The Experience of a Randomized Clinical Trial of … · anti-VEGF treatment over the course of the study No anticipated ocular treatment except for anti- ... EVT eccentric viewing

The Experience of a RandomizedClinical Trial of Closed-CircuitTelevision Versus Eccentric ViewingTraining for People withAge-Related Macular DegenerationSusan J. Leat, Francis Fengqin Si, Deborah Gold, Dawn Pickering,Keith Gordon, and William Hodge

Structured abstract: Introduction: In addition to optical devices, closed-circuittelevisions (CCTVs) and eccentric viewing training are both recognized interven-tions to improve reading performance in individuals with vision loss secondary toage-related macular degeneration. Both are relatively expensive, however, either inthe cost of the device or in the amount of time personnel need to provide training.In this randomized trial, we compared the effectiveness of these two interventions.Methods: Participants with age-related macular degeneration and visual acuitybetween 6/48 (20/160) and 6/120 (20/400) first received basic low vision care,including optical devices. At the subsequent baseline visit, they undertook a batteryof measures including logMAR visual acuity; reading speed and accuracy for text in1.3M and 1M fonts; reading information on medicine bottles, utility bills, and foodpackages; the NEI-VFQ; the Geriatric Depression Scale; and a reading inventoryquestionnaire. They were then randomized to either obtaining a CCTV for home useor eccentric viewing training over the following six weeks. Results: Recruitment wasmore difficult than expected for this population. Of 145 patients referred, 29 met theinclusion-exclusion criteria, 14 were willing to enroll, and 10 completed the trial. Forthe primary outcome (reading speed for 1.3M print), there was a significant im-provement between baseline and outcome for the CCTV group (p � 0.005), but notfor the eccentric viewing training group (p � 0.28), and the CCTV group showedsignificantly greater change (p � 0.04). There was a nonsignificant improvement inreading speed for 1M text and a decrease in the amount of time taken to read utilitybill information in the CCTV group. There was a significant improvement in nearvisual acuity with current glasses with eccentric viewing training. The other mea-sures did not reach statistical significance. Discussion: Randomized clinical trials forlow vision rehabilitation, particularly in the elderly population with vision loss, arechallenging, but such trials are important for the allocation of resources. This trialshowed early indications of more impact on reading performance from CCTV than

354 Journal of Visual Impairment & Blindness, July-August 2017 ©2017 AFB, All Rights Reserved

In Western countries, age-related maculardegeneration is the most frequent causeof severe visual impairment (Klein, Lee,Gangnon, & Klein, 2013; Quartilho et al.,2016) and reading is the most commongoal—it is the first or second rehabilita-tion goal for 96% of this population(Elliott et al., 1997). People with age-relatedmacular degeneration usually requiremagnification in order to be able to readstandard print. Magnification can be pro-vided either by optical devices or, for mod-erate and advanced vision loss, electronicvideo enhancement systems or videomagnifiers, commonly called closed-circuit televisions (CCTVs). The signif-icant advantages of CCTV over opticalmagnifiers are that it provides high levelsof magnification with a greater field ofview (compared to the equivalent opticaldevice); allows reading at a more typicalviewing distance of about 40–50 cm(15.8�–19.7�); and allows binocular view-ing (which higher-powered optical mag-nifiers cannot) (Peterson, Wolffsohn, Ru-binstein, & Lowe, 2003). There is ageneral consensus among studies thatreading speeds are faster with CCTVscompared to optical magnifiers and thatthe duration of reading is increased

Funded by Lawson Research Institute in Lon-don, Ontario (Lawson IRF-063-08 and SJHCFoundation-Jarmain Family Fund). Our thanksgo to Shampa Bose for coordinating the studyand Julia Baryla (University of Western On-tario), Jane Chen, Susan Nieto, Suzanne Decaryand Roxanne Hazell at CNIB (formerly Cana-dian National Institute for the Blind), Toronto,and Lisa Hamm, Betty Leeson, Sherry Malchoat CNIB, London, Ontario, for help in recruitingparticipants and collecting data. Alex Mao aidedwith data analysis and Optelec contributed to-

©2017 AFB, All Rights Reserved Journal of

(Goodrich & Kirby, 2001; Peterson etal., 2003).

Those with more advanced age-relatedmacular degeneration develop a centralscotoma, which necessitates the develop-ment of a preferred retinal locus for fix-ation, instead of the dysfunctional ana-tomical fovea. Although preferred retinallocus development occurs naturally withtime for the majority of patients (Cross-land, Culham, Kabanarou, & Rubin,2005; Fletcher & Schuchard, 1997), it isthought that in many cases the naturallydeveloped preferred retinal locus is not inthe ideal position (Fine & Rubin, 1999;Fletcher & Schuchard, 1997; Nilsson,1990; Petre, Hazel, Fine, & Rubin, 2000).Therefore, eccentric viewing trainingis commonly recommended (Owsley,McGwin, Lee, Wasserman, & Searcey,2009; Stelmack, Massof, & Stelmack,2004) with several purposes in mind: todevelop the more consistent and efficientuse of a preferred retinal locus; to speedup the process of developing a preferredretinal locus; and to optimize the pre-ferred retinal locus position (Gaffney,Margrain, Bunce, & Binns, 2014).

Both of these interventions for moreadvanced vision loss are relatively expensive.Currently, handheld and tabletop CCTVsrange in price from $500 to $3,000. Theamount of time involved in eccentricviewing training varies between approxi-mately 1 and 14 hours (Gaffney et al.,2014; Stelmack et al., 2004), with an es-timated average of 4 hours (Stelmack etal., 2004), and it is costly if undertaken byan occupational therapist or low visiontherapist, since their fees for 4 or up to 14hours of work needs to be paid by thegovernment, private insurance, or the

Visual Impairment & Blindness, July-August 2017 355

not know the dose effect for eccentricviewing training—that is, it is not knownhow much is sufficient to gain the nearmaximum improvement and at what pointfurther training does not yield furtherbenefit (Gaffney et al., 2014). There arevery few randomized clinical trials ofthe effectiveness of eccentric viewingtraining, and even fewer in comparison toother interventions (Gaffney et al., 2014;Hamade, Hodge, Rakibuz-Zaman, &Malvankar-Mehta, 2016).

Depending on what is funded or af-fordable for patients, some clinics mayspend more resources on eccentricviewing training while others spendmore on electronic devices. In the prov-ince of Ontario, Canada, there may be atendency to use resources for CCTVs,since these are funded through the As-sistive Devices Program (ADP) for eli-gible individuals (Ontario Ministry ofHealth and Long Term Care, 2008).

In an ideal world, one might want toinclude both CCTV and eccentric view-ing training, but given the reality of lim-ited resources, agencies need to considerwhich of these treatments or interventionswould have the bigger impact. Assumingthat resources are not limitless, it is im-portant to know which interventions aremore effective in order to improve read-ing for people with age-related maculardegeneration. To answer this question, weinitiated a randomized clinical trial ofCCTV provision versus eccentric viewingtraining for people with moderate to ad-vanced age-related macular degenerationwho had already received a low visionassessment and appropriate optical de-vices. The primary hypothesis was that aCCTV would provide greater increases in

356 Journal of Visual Impairment & Blindness, July-August 2

ing training (specifically, that it would im-prove reading speed by at least 10 wordsper minute for 1.3M print). Secondaryoutcomes were: reading accuracy for1.3M reading speed, and accuracy for 1Mprint, and reading performance for utilityand telephone bills and a medicine bottlelabel. The following instruments (question-naires) were also used to measure out-comes: a reading behavior inventory, theVFQ-25 plus questions 3 and A4, and theGeriatric Depression Scale.

MethodsThis study was a prospective, random-ized, parallel-armed clinical trial. The set-ting was CNIB (formerly Canadian Na-tional Institute for the Blind), Toronto,Canada, which draws patients from abroad population base of six million in theGreater Toronto area in southern Ontario.We aimed for an initial sample of 30participants. Inclusion and exclusion cri-teria are listed in Table 1. The better endof the visual acuity range was selected sothat prospective participants would havebeen likely to have central vision loss andrequire CCTV or eccentric viewing train-ing, and the poorer limit was chosen be-cause individuals with poorer vision thanthe range specified would have been un-likely to benefit sufficiently from the op-tical devices that would be provided tothose in the eccentric viewing traininggroup of the study.

The study received ethics clearancethrough the Western University ResearchEthics Board and followed the tenets ofthe Declaration of Helsinki on EthicalPrinciples for Medical Research Involv-ing Human Subjects. All participants

017 ©2017 AFB, All Rights Reserved

clinical trial was registered with Clinical-Trials.gov (2017).

The study protocol is shown in Figure1. After patients had received a standardlow vision assessment from the low vi-sion therapist at CNIB and met the initialeligibility criteria (diagnosis, reading as agoal, English language ability, and no ob-vious cognitive difficulties), they were in-vited to participate. The low vision as-sessment included: case history and goalassessment; distance visual acuity withthe Early Treatment Diabetic RetinopathyStudy (ETDRS) chart; near visual acuitywith continuous text print; contrast sensi-tivity assessment; determination of mag-nification; a trial of optical devices; andmodification of magnification to deter-mine the optimum device and magnifica-tion. The magnification was based on thenear reading acuity and the goal print size

Table 1Inclusion and exclusion criteria.

Initial inclusion criteria

Diagnosis of AMD reducing visual acuity tobetween 20/160 and 20/400 (logMAR0.9–1.3) in the better eye

First-time patient at CNIBAged over 50 yearsNo previous EVT or CCTVAble to read EnglishA helper at home to help with EVT

Exclusion criteria

No anticipated ocular treatment includinganti-VEGF treatment over the course ofthe study

Reading not being a goalMinimental (Folstein, et al., 1975) score �

22 (the copy design task was enlarged to a8.5 � 11 page)

Other ocular disease reducing central vision

AMD � age-related macular degeneration; EVT �television.

(which was 1.3M or the patient’s own

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goal, whichever was smaller), and incor-porating a 2X acuity reserve (Lovie-Kitchin, 2011). The final device was theone that gave maximum reading fluencyfor the target print size. Demonstration ofreading stands, line guides, illumination,and fit-overs for glare was also included.If the optimum aid for reading was ahandheld or stand magnifier, this devicewas provided through the CNIB. Theclient was directed to go to his orher eye care practitioner for provision ofspectacle-mounted microscopes (prismhalf eye or full field microscope). Fit-overs for glare were available throughCNIB, and prescription tints were pro-vided through the eye care practitioner.To increase recruitment, we asked optom-etrists in Toronto who were known to offerlow vision services to refer potential par-ticipants. In these cases, the initial

Relaxed inclusion criteria

or referral to the study, the lower limit of VA waschanged to 20/630, so as to allow for thepossibility of improvement with new glassesnchangednchangednchangednchangednchanged

Relaxed exclusion criteria

anticipated ocular treatment except for anti-EGF treatment over the course of the study

changedchanged

changed

ntric viewing training; CCTV � closed-circuit

F

UUUUU

NoV

UnUn

Un

ecce

low vision assessment and provision of

Visual Impairment & Blindness, July-August 2017 357

Figure 1. Study protocol. VA � visual acuity; OH � ocular health; MMSE � Mini MentalStatus Exam; VFQ � VFQ-25; RBI � Reading Behavior Inventory; GDS � Geriatric Depres-

358 Journal of Visual Impairment & Blindness, July-August 2017 ©2017 AFB, All Rights Reserved

optical devices were undertaken by theoptometrist.

BASELINE VISIT

After a six-week period to allow partici-pants time to visit their eye care practi-tioners, obtain microscopes, and practicewith standard low vision devices, the par-ticipants attended CNIB for the baselineassessment. An eye care practitioner per-formed an eye examination to determineeligibility regarding the eye condition orconditions and ocular history. Then thefollowing were performed and recorded:ETDRS distance visual acuity for botheyes with by-letter scoring, near readingacuity with the current spectacles for botheyes with the Lighthouse chart, readingacuity with the current optical aid, thetype of optical aids, Mini Mental StatusExam (MMSE), Geriatric Depression Scale,and a check for fulfillment of other in-clusion criteria.

Reading speed and accuracy wereassessed with elementary school fifthgrade–level texts that were approximately150 words long in either 1.3M or 1Mprint. Print that is 1.3M is equivalent to12-point font, which is commonly used inletters and documents, whereas 1M printrepresents average newsprint. Four pas-sages were selected that had been previ-ously validated in the lab of Dr. Leat.The paragraphs did not contain un-common proper nouns or any quotedspeech. Out of eight candidate para-graphs, four paragraphs were selectedand matched in pairs to the closest Flesch-Kincaid grade and the closest (almostidentical) average reading speeds. Twowere assigned to the 1.3M print andtwo to the 1M print. The order of the

©2017 AFB, All Rights Reserved Journal of

randomized to baseline or outcome be-tween participants. For this task, par-ticipants were allowed to use their pre-ferred optical devices and were allowedto adjust the lighting (both were re-corded). They were asked to read outloud as fast as possible, but withoutsacrificing accuracy. After a demonstra-tion of the task with a different text,participants were asked to read the para-graphs. The participant was handed thetext, and timing with a stopwatchstarted when reading began. All errorswere recorded. The number of correctwords per minute and the number oferrors per 100 words were calculated.

Three other reading tasks were included,which were modeled on Dougherty etal. (2009). These were: reading theamount due on a utility bill, microwavecooking time that was indicated on afood package, and the patient’s nameand dosage (number of tablets per day)on a medicine bottle. The amount oftime taken and the accuracy were re-corded for each. As for the text reading,participants were allowed to use theirpreferred devices and lighting. Theychose their preferred lighting and de-vice using a demonstration version ofeach task. There were two versions ofeach task, which were randomized be-tween participants to baseline or out-come visit. There was an upper timelimit of two minutes for each of thesetasks, after which time they were re-corded as incorrect if the patient had notresponded.

Participants were asked verbally abouttheir reading patterns using Questions 1and 3 from the Reading Behavior Inven-tory (Goodrich, Kirby, Wood, & Peters,

Visual Impairment & Blindness, July-August 2017 359

2001) was administered using standardprocedure, with the additional instruction“if you use a low vision device for anactivity, please answer the questions asthough you were using it.” The additionalquestions A3 and A4 were included, giv-ing a total of 27 questions. Last, the Ge-riatric Depression Scale-15 was adminis-tered (Yesavage et al., 1982).

After these tasks, participants were ran-domized into either the CCTV or the ec-centric viewing training group. Random-ization was stratified by presenting visualacuity (group 1: 0.90 –1.00 logMAR;group 2: 1.00–1.20; group 3: 1.20–1.3).The intervention protocols are shown inBoxes 1 and 2. The duration of both in-terventions was six weeks. The eccentricviewing training was undertaken by a lowvision therapist and the protocol includedcomponents which are commonly in-cluded by low vision therapists (Stelmack

CCTV inThe 22� Clearview tabletop CCTV was usCCTV assessment (within one week of ran

Assistive Devices Program (ADP) assesAfter determining the participant’s reread thegoal print was assessed, the mwas multiplied by 5X, and then the pmagnification until they could comformagnification was recorded and the pparticipant was trained to use the CC

The CCTV was delivered and set up at thThe participant was asked to use the CCTV

each day during a six-week period.During the trial period, the participant rece

to check the setup and their use of the C

CCTV � closed-circuit television.

Box 1

et al., 2004).

360 Journal of Visual Impairment & Blindness, July-August 2

OUTCOME VISIT

The outcome assessment was the sameas the baseline, with the exception thatparticipants in the CCTV group wereasked to use the CCTV for the readingtexts and those in the eccentric viewingtraining group were asked to use theirtrained preferred retinal locus. For theother reading tasks (the utility bill, med-icine bottle, and food package), partic-ipants were allowed to use whicheverdevice, viewing strategies, and lightingthat they preferred—that is, those in theCCTV group could choose to use theiroptical device or the CCTV. After theoutcome visit, both groups were offeredthe alternative treatment.

DATA ANALYSIS

The reading speed measurements werecalculated in log10 correct words per min-

ventionor all participants in the study.

ization). This was based on the standardnt procedure, briefly described as follows:g goals, the minimum magnification toification was recorded, this magnificationipant was allowed to increase or decreasey and fluently read the goal print. Thisrred polarity was determined. Last, thecontrols.tient’s house.a minimum of two sessions of 10 minutes

two phone calls with standard questionsV.

tered fdom

smeadinagn

artictablrefeTVe pa

for

ivedCT

ute (log CWMP) for analysis. The main

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Eccentric viewing training interventionFirst EVT training visit (within one week of randomization, duration 1.5 to 2 hours)• For the better eye, the central scotoma was plotted with a tangent screen.• Training started with blind-spot awareness (Fletcher & Schuchard, 1997) using the

face method.• The likely direction of eccentric viewing was determined from the tangent screen

plot, confirmed with the clock or face method. If the field loss was symmetric aroundfixation, the participant was asked to move their gaze upwards (since this is one ofthe most common and effective directions for EVT (Fletcher & Schuchard, 1997;Petre et al. 2000). If there was an asymmetric scotoma, the participant was asked tomove their gaze to give the best horizontal area of intact visual field for reading,extending to the right, and which was nearest to fovea. This gaze shift wasdemonstrated with the Amsler chart or tangent screen.

• The direction was confirmed with the clock or face method. The participant wasasked to fixate on the center of the trainer’s face or a clock and to note which sectionof the face or numbers on the clock were clearest. Fixation was moved away fromthe clearest section. If there was no clear preference, the EVT position would bechosen to be upwards (as above).

• Using Quillman-type exercises, a print size two times larger than the participant’snear visual acuity (with their bifocal glasses) was chosen. The participant was trainedto move their fixation in the direction of the determined EVT. The amount ofimprovement in near visual acuity for print with EVT was determined.

• Quillman-type exercises in a range of print sizes were provided (including thresholdand 2X smaller and 2X larger than threshold) for both with and without the opticalmagnifier.

• Last, the EVT was demonstrated with the participant’s own optical aid.• For the home training, the participant was asked to practice with an observer and

simply give feedback regarding their level of accuracy.• They were asked to practice for at least two sessions of 10 minutes each per day for

three weeks.

The participant received one phone call with standard questions between sessions 1 and 2to check their compliance and use of an observer.

Second EVT visit (three weeks later, duration 1.5 to 2 hours)• After reviewing the participant’s progress, steady-eye strategy (Gaffney et al., 2014)

was demonstrated, during which the participant maintains his or her fixation in theEVT position, rather than making a fixation movement to each word and then to theEVT position.

• A new range of exercise print sizes was determined and provided. The participantwas asked to practice for another three weeks.

EVT � eccentric viewing training; CCTV � closed-circuit television.

Box 2

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outcomes, which are the reading speedsand accuracies, were analyzed by two-way two-sample t-tests between the pre-and post-results for the CCTV and ec-centric viewing training groups. Pairedt-tests were also undertaken betweenthe pre- and post-measures for eachgroup separately.

ResultsIn this study, we aimed for 30 partici-pants. After 8 months, only 3 had beenrecruited, and only 7 by 1 year. We lostpotential participants at each step of therecruitment process. At the end of 2 years,of 145 patients referred to CNIB in thattime frame, 35 charts were reviewed aspotential participants, 29 met the inclusion-exclusion criteria (the others either didnot meet the visual acuity requirement,had communication difficulties secondaryto English as a second language, or had alack of support to perform the eccentricviewing training at home). Of these 29, 14were willing to participate (the otherswere not willing for reasons includingunwell health, feeling there would betravel difficulties (despite being offered ataxi service), having too many doctor’sappointments, feeling that they could notask their child to take them to more ap-pointments, believing that they would notbenefit, lacking the patience to do dailytraining, or being uninterested. At thenext visit (the baseline visit), we also lostparticipants whose visual acuity was im-proved to better than the inclusion crite-rion after they received new spectaclesfrom their eye care practitioner whomthey had seen between visits. Early in therecruitment process, we realized that the

362 Journal of Visual Impairment & Blindness, July-August 2

ideal). We relaxed them as indicated inTable 1.

After 18 months, to recruit more par-ticipants, a decision was made to movethe study to CNIB, London, Ontario,another large city where CNIB is thelargest provider of low vision services.Eventually, after 2 years of recruit-ment, a decision was made to close thestudy.

Of the 10 participants who finally com-pleted the study, 4 were randomized tothe eccentric viewing training group (av-erage age 82, 2 of whom were female)and 6 to the CCTV (average age 83.5, 3 ofwhom were female).

At baseline, there were no significantdifferences in distance visual acuity,reading speeds, reading accuracy, theamount of time taken for reading tasks,MMSE, Geriatric Depression Scale, orthe VFQ (composite score or any sub-scales) between the two groups (p �0.05). However, there was a significantdifference in near logMAR visual acu-ity with the current glasses (eccentricviewing training group � 1.42, CCTVgroup � 1.3, p � 0.035), where a higherlogMAR score represents poorer visualacuity.

Figure 2 shows the primary outcomevariable (reading speed for 1.3M text).Within the CCTV group, there was a sig-nificant improvement at the outcome visitcompared to the baseline (paired t-test,p � 0.005), but not within the eccentricviewing training group (p � 0.28). Atwo-sample t-test of the changes (pre-post) showed a significant difference be-tween the groups (p � 0.04). Figure 3shows the secondary outcome of read-ing speed for 1M text. There was no

017 ©2017 AFB, All Rights Reserved

for 1

within the eccentric viewing training orthe CCTV group, although this almostreached significance within the CCTVgroup (p � 0.051). The between-groupsdifference in change (pre-post) did notquite reach significance (p � 0.089).Similar analyses for accuracy showedno significant differences.

Figure 4 shows the results for theamount of time taken to read the utilitybill. There was, however, a significantimprovement in the amount of timetaken within the CCTV group, but not

Figure 2. Primary outcome: Reading speed

Figure 3. Secondary outcome: Reading speed fo

©2017 AFB, All Rights Reserved Journal of

within the eccentric viewing traininggroup, and there was no significant dif-ference in the change (pre-post) be-tween the groups. It is noteworthy thatthe large variability in the amount oftime taken at baseline is mostly due toone individual who read the bill veryquickly.

Figure 5 shows the changes in nearvisual acuity. There was a significantimprovement in near visual acuity (withcurrent eyeglasses) within the eccentricviewing training group, but no signifi-

.3M text (average � SD).

r 1M text (average � SD).

Visual Impairment & Blindness, July-August 2017 363

utili

cant difference pre-post between thegroups.

For all other measures there were nosignificant differences between or withinthe groups.

DiscussionDespite the small sample size, this trialshowed early indications of more im-provement in reading speed with CCTVthan from eccentric viewing training.There was a significant improvement in

Figure 4. Amount of time taken to read the

Figure 5. Near reading acuity with own eyeglass

364 Journal of Visual Impairment & Blindness, July-August 2

the main outcome variable (reading speedfor 1.3M print) in the CCTV group andbetween the two groups. There was nosignificant improvement in reading speedwithin either group for 1M print, althoughit almost reached significance withinthe CCTV group. There was faster per-formance with the utility bill withinthe CCTV group. These results are inagreement with the results of Vukicevicand Fitzmaurice (2005), in which theyfound that eccentric viewing training did

ty bill (average � SD).

es (average � SD).

017 ©2017 AFB, All Rights Reserved

not make any further improvement overmagnification in the performance of dailyliving tasks that require high acuity,while eccentric viewing training eitherwith or without magnification improvedparticipants’ perceived ability for low-acuity tasks such as shopping or house-hold chores. Studies of eccentric viewingtraining alone have shown a modest in-crease of reading speed of 25% to 34%(Kasten, Haschke, Meinhold, & Oertel-Verweyen, 2010; Verdina et al., 2013).We found an increase of 16% with eccen-tric viewing training with 1.3M print(which was not significant) compared toan 86% increase with CCTV for 1.3Mand 74% for 1M print. These increaseswith CCTV are similar to those found byPeterson et al. (2003), who reported thatreading with a stand-mounted CCTV was73% faster than with an optical aid. Thisfinding indicates that for the task ofreading, CCTV will give the greater ben-efit.

Interestingly, in the present study, nearvisual acuity with the participants’ ownspectacles improved after eccentric view-ing training. This latter finding may indi-cate that eccentric viewing training has aplace in the armory of low vision reha-bilitation interventions. Although visualacuity was still reduced (logMAR 1.28,which is close to 20/400), some improve-ment may be obtained for low-acuitytasks such as dressing, grooming, and mo-bility (Vukicevic & Fitzmaurice, 2005). Butfor high-acuity, reading-related tasks,magnification is still required, since evenwith eccentric viewing training visualacuity is limited by the use of the pre-ferred retinal locus, which is eccentric tothe fovea—that is, eccentric viewing

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either optical or electronic magnifyingdevices.

This study illustrates how undertakingrandomized clinical trials—particularlythose for elderly people with visionloss—is challenging, which may be partof the reason that there are very few ran-domized clinical trials of low vision re-habilitation (Leat, 2016). Many of thosethat do exist compare usual rehabilitationwith a delayed provision of services (Stel-mack et al., 2008; Stelmack, Tang, Wei,& Massof, 2012). Reeves, Harper, andRussell (2004) recruited 194 participantsfor a study comparing conventional lowvision rehabilitation with low vision re-habilitation that was “enhanced” withhome visits. There are also very few ran-domized clinical trials of eccentric view-ing training (Gaffney et al., 2014). Vu-kicevic and Fitzmaurice (2005) comparedeccentric viewing training, eccentric view-ing training plus magnification, magnifica-tion alone, and a nonintervention group.However, they combined a previous piloteccentric viewing training group with therandomized eccentric viewing traininggroup, and it also appears that the eccen-tric viewing training was done with acomputer program at home.

To undertake this type of trial, a large,accessible population or multicenter trialsare required to recruit a sufficient numberof participants, since there are manyreasons why people are ineligible or arenot able or willing to participate. In par-ticular, it may be difficult to recruit visu-ally impaired participants to studies thatinvolve multiple visits and training. Al-though eccentric viewing training is un-dertaken at CNIB, it does not usuallyrequire the person to return for multiple

Visual Impairment & Blindness, July-August 2017 365

effortful training program, participantswho are already elderly and visually im-paired, and who are often experiencingmultiple morbidities, may be reluctant totake part.

We originally set up the inclusion-exclusion criteria to be optimal for a suc-cessful outcome, but had to relax a num-ber of these (see Table 1). For example, itwas ideal that no ocular treatment of anykind should be undertaken during thetrial, since this might have changed visualfunction and have influenced the results.But we had to change this criterion in thecase of anti-VEGF treatment, since it is socommon in the relevant population. How-ever, the strength of a randomized clinicaltrial such as the present study is that therandomization between groups ensuresthat this factor would be similar betweenthe groups at the close of the study.

Randomized clinical trials are consid-ered the strongest form of study for aclinical intervention, but it is clear thatthey are difficult and not possible in allsituations. Nor is it possible to alwaysmask the personnel who perform the out-come assessment as to which group aparticipant belongs. For example, in thecurrent study it was clear whether theparticipant was using a CCTV or not.Despite the difficulties of these types oftrials in this population, more are neededin order to obtain a larger evidence basefor optimum and cost-efficient provisionof low vision rehabilitation.

ConclusionRandomized clinical trials for low visionrehabilitation, particularly in the elderlypopulation, are challenging, but such tri-als are important for allocation of re-

366 Journal of Visual Impairment & Blindness, July-August 2

show early indications of more impact onreading speed from CCTV than from ec-centric viewing training. In most situa-tions where funds are limited, it seemsthat providing CCTV would be more ef-fective for people’s primary goal thanwould eccentric viewing training.

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Susan J. Leat, Ph.D., F.C.Optom., professor,School of Optometry and Vision Science, Univer-sity of Waterloo, 200 University Avenue West,Waterloo, ON N2L 3G1, Canada; e-mail: [email protected]. Francis Fengqin Si, M.D., PGY1resident, Family Medicine, Western University,SJFMC, 346 Platt’s lane, London, Ontario, N6G1J1, Canada; e-mail: [email protected]. Deb-orah Gold, Ph.D., executive director, BALANCEfor Blind Adults, The Crossways Complex, 2340Dundas Street West, Unit G-06, Toronto, ON,M6P 4A9, Canada; e-mail: [email protected]. Dawn Pickering, B.Sc., CLVT, business de-velopment executive, 1 Yonge Street, Suite 1801,Toronto, ON, M5E 1W7 CARF, Canada; e-mail:[email protected]. Keith Gordon, Ph.D., vicepresident research, CNIB, 1929 Bayview Avenue,Toronto, Ontario, M4G 3E8, Canada; e-mail:[email protected]. William Hodge, M.D.,Ph.D., professor of ophthalmology and epidemiol-ogy, Western University, 268 Grosvenor Street, Lon-don, ON, N4A 4V2, Canada; e-mail: [email protected]. Address all correspondence to Dr. Leat.

368 Journal of Visual Impairment & Blindness, July-August 2

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