1 Evidence Based Treatment of Amblyopia in 2005 What we have learnt from the Pediatric Eye Disease...

1

Evidence Based Treatment of Amblyopia

in 2005

What we have learnt from the Pediatric Eye Disease Investigator Group [PEDIG]

Lionel Kowal

2

• Amblyopia is the most common cause of monocular visual impairment in children.

• Existing data on the treatment of amblyopia largely retrospective / uncontrolled.

Rationale for PEDIG Amblyopia Studies

3

PEDIG : Network of community & university- based ophthalmologists and

optometrists• A Randomized Trial of Atropine Versus Patching for

Treatment of Moderate Amblyopia in Children - ATS 1• A Randomized Trial Comparing Part-time Versus Full-time

Patching for Severe Amblyopia - ATS 2A• A Randomized Trial Comparing Part-time Versus Minimal-

time Patching for Moderate Amblyopia - ATS 2B• Prospective Study of Recidivism After Cessation of

Amblyopia Treatment - ATS 2C• An Evaluation of Treatment of Amblyopia in

Children 7-<18 Years Old – ATS3• A Randomized Trial of Atropine Regimens for Treatment of

Moderate Amblyopia in Children – ATS4

ATS1 4

Amblyopia Treatment StudyATS 1

A Randomized Trial of Atropine Versus Patching

for Treatment of Moderate Amblyopia in Children

The Pediatric Eye Disease Investigator Group. A randomized trial of atropine vs patching for treatment of moderate pamblyopiaArchives of Ophthalmology 2002;120:268-278

ATS1 5

• To compare patching and atropine as treatments for moderate amblyopia in children 3 to <7 years old

• To develop estimates of the success rates of treatment

• To identify factors that may be associated with successful treatment

Objectives

ATS1 6

• A randomized, controlled single-masked multi-center clinical trial

• 2 treatment groups

• Primary outcome: VA @ 6 mo

• Treatment after 6 mo: investigator discretion

Patching

Atropine

Study Design

ATS1 7

Eligibility Able to measure VA with single surrounded

HOTV

• Strabismic and/or anisometropic amblyopia

• Visual Acuity: – Amblyopic eye: 6/12 to 6/30– Sound eye: 6/12 or better– 3 lines or more interocular difference

• < 2 mo of amblyopia therapy in prior 2 y

ATS1 8

Electronic Visual Acuity Tester

20/400 20/200 20/100 20/50 20/25

Holmes, JM, Beck, RW, et al The Amblyopia Treatment Study Visual Acuity Testing Protocol Archives of Ophthalmology 2001:119;1345-1353.

ATS1 9

Patching Treatment

• Initial– 6 h/d up to all waking hours at investigator’s

discretion

• Subsequent (@ 17 w)– If <6/9 and <3 line improvement, increase up to

all or all but one waking hours

– If >6/9 or >3 line improvement, investigator could decrease patching to a minimum of 1 h/d

ATS1 10

Atropine Treatment

• Initial– 1 drop atropine 1% daily in sound eye

• Subsequent (@ 17 w)

– If <6/9 and <3 line improvement, replace hypermetropic lens of sound eye with plano

– If >6/9 or >3 line improvement, investigator could decrease atropine to 2/w

ATS1 11

Amblyopia Treatment Index• Questionnaire of 18 items, each scored from 1 to 5,

with 5 representing the most difficult

• Three subscales measured

adverse effects of treatment difficulties with compliance social stigma of treatment

• Items are summed to create each subscale score, then scaled to a common range

The Pediatric Eye Disease Investigator GroupImpact of Patching and Atropine Treatment on the Child and Family in the Amblyopia Treatment Study Archives of Ophthalmology 2003:121;1625-1632

ATS1 12

Patient Characteristics

Female 47%

Caucasian 83%

African American 5%

Hispanic 6%

Asian 2%

Mixed 2%

Other 2%

N=419

ATS1 13

<3 y 2%

3 to <4 y 15%

4 to <5 y 20%

5 to <6 y 33%

6 to <7 y 30%

Mean Age 5.3 y

Age n=419

ATS1 14

Strabismus 38%

Anisometropia 37%

Combined-mechanism 24%

Cause of Amblyopia n=419

Prior Treatment

26% received previous treatment for amblyopia

ATS1 15

Patient Follow Up

Patching Group215

Atropine Group204

6 Month Exam Completed 208 (97%)

Patients Randomized419

6 Month Exam Completed194 (95%)

2 Year Exam Completed 176 (86%)

2 Year Exam Completed 187 (87%)

ATS1 16

Patching Group: Number of Hours of Patching Prescribed

43%

30%

20%

7%

6 hours

8 hours

10 hours

>=12 hours

At Enrollment

30%

27%

33%

10%

6-7 hours

8-9 hours

>=12 hours

Maximum

10-11 hours

The number of hours prescribed at baselinewas the maximum for 80% of patients

ATS1 17

Atropine Group

• All patients prescribed one drop of 1% atropine daily

• A plano spectacle lens was prescribed for the sound eye during follow up for 56 /194 patients

ATS1 18

Amblyopic Eye Acuity at 6 Months

Patching Atropine (N=208) (N=194)

Mean improvement from 3.16 lines 2.84 linesbaseline

Mean acuity at 6 months 6/9 6/9-2

(Snellen approximation)

>6/9 or >3 line improvement from baseline 79% 74%

ATS1 19

0%

20%

40%

60%

80%

100% Patching

0%

20%

40%

60%

80%

100%

Atropine

Amblyopic Eye at 6 MonthsA

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6-month Amblyopic Eye Visual Acuity

>20/16

>20/20

>20/25

>20/32

>20/40

>20/50

>20/63

>20/80

>20/100

>20/125

>20/160

N=208

N=194

ATS1 20

Amblyopic EyeMean Acuity at Each Visit

Patching Atropine20/20

20/25

20/30

20/40

20/50

20/60

20/80

20/60-

20/40

20/30- 20/30

20/50+

20/40+20/30-2

5 wks 6 mos0 wks 16 wks

ATS1 21

Treatment Effect in Subgroups at 6 Months

• Effect of treatment was similar in subgroups based on:

• Age: – <5 years old, >5 years old

• Cause of amblyopia: – strabismus, anisometropia, combined

• Baseline visual acuity in amblyopic eye– 20/80 to 20/100 , 20/40 to 20/60

ATS1 22

Effect of Treatment on Sound Eyeat 6 Months

• A decrease in visual acuity of 1 or more lines at 6 months:

patching - 17 patients (8%) atropine - 47 patients (23%)

• Some cases were due to improper refractive correction

• In other cases there likely was residual cycloplegia from atropine not having been discontinued

ATS1 23

Ocular Side EffectsAny ocular side effect 26%

Types of ocular side effectsLid/conjunctival irritation 4%Light sensitivity 18%Eye pain/headache 2%Other 2%

Facial Flushing 2%

Systemic Side Effects 3%

* Reported at any visit in first 6 months

Atropine Side Effects*N=208

ATS1 24

Skin Irritation

Mild 41%

Moderate/Severe 6%

* Reported at any visit in first 6 months

Patching Side Effects*N=215

ATS1 25

Amblyopia Treatment Index• Both treatments were well tolerated

• All 3 subscale scores were consistently worse in the patching group

Median ScoreSubscale Patching AtropineAdverse Effects 2.25 2.00

Difficulty with Compliance 2.20 1.80

Social Stigma 3.00 2.00

ATS1 26

Amblyopic Eye Acuity at 2 YearsPatching Atropine

(N=188) (N=179)

Mean improvement from 3.7 lines 3.6 linesbaseline

Mean acuity at 2 years 20/32+2 20/32+1

(Snellen approximation)

>20/32 or >3 line improvement from baseline 86% 84%

Two-year follow-up of a 6-month randomized trial of atropine vs patching for treatment of moderate amblyopia in children.Arch Ophthalmol. 2005 Feb;123(2):149-57.

ATS1 27

0%

20%

40%

60%

80%

100%

Atropine

0%

20%

40%

60%

80%

100% Patching

Amblyopic Eye at 2 YearsA

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>20/16

>20/20

>20/25

>20/32

>20/40

>20/50

>20/63

>20/80

>20/100

>20/125

>20/160

N=188

N=176

ATS1 28

Summary

• There was substantial improvement in amblyopic eye visual acuity with both treatments

• Improvement was more rapid in the patching group

• The difference between groups in amblyopic eye acuity at six months was small (about a third of a line)

• There was no difference between groups in amblyopic eye acuity after 2 years

ATS2 29

Amblyopia Treatment StudyATS 2A, 2B, 2C

AN EVALUATION OF PATCHING REGIMENS

ATS2 30

• Patching is most commonly prescribed. However, controversy exists concerning how much treatment is necessary.

• Most data on the response according to the daily dosage of patching are retrospective and uncontrolled.

• There is no standard of care once initial treatment of amblyopia is completed.

Rationale

ATS2 31

Randomized Trials

Patching 2 hours versus 6 hours daily for moderate amblyopia (20/40 to 20/80)

Patching 6 hours versus full-time for severe amblyopia (20/100 to 20/400)

ATS2 32

Eligibility• Age < 7 years

• Able to measure visual acuity with single surrounded HOTV optotypes


• Visual acuity: – Amblyopic eye: 20/40 to 20/400– Sound eye: 20/40 or better– 3 lines or more interocular difference

• No more than 2 months of amblyopia therapy in prior 2 years

ATS2 33

Severe Amblyopia Trial20/100-20/400

Moderate Amblyopia Trial 20/40-20/80

Randomize Randomize

Full-time patchingall or all but 1 hr per day

Part-timepatching

6 hrs per day

Part-timepatching

6 hrs per day

Minimal-timepatching

2 hrs per day

Visit A: 5 ± 1 weekVisual acuity testing both eyesOcular alignment assessmentAmblyopia Treatment Index

Visit B: 17 ± 1 weekVisual acuity testing (masked) both eyes

Ocular alignment assessmentStereoacuity Testing

Study Design

ATS2 34

Treatment ProtocolSevere amblyopia: 6 hours of patching

Full time patching

Moderate amblyopia: 2 hours of patching 6 hours of patching

All treatment groups were prescribed at least 1 hour of nearactivities while patching.

Investigator - Patching decreased to no less than 7 hours per week

Investigator - Patching could be continued, reduced, or stopped

ATS2B 35

Results ATS 2B

2 vs. 6 hours of patching

for moderate amblyopia (20/40 – 20/80)

The Pediatric Eye Disease Investigator GroupA Randomized Trial of Patching Regimens for Treatment of Moderate Amblyopia in ChildrenArchives Of Ophthalmology 121:2003;603-611

ATS2B 36

Patient CharacteristicsN=189

Female 44%

Caucasian 85%

Age (mean) 5.2 years

Cause of Amblyopia

Strabismus 40%

Anisometropia 33%

Combined 27%

Prior Amblyopia Treatment 14%

ATS2B 37

Patient Follow Up

2 Hour Groupn=95

6 Hour Groupn=94

Patients Randomized

N=189

4-MONTHMASKED

EXAM

Completedn=92

(97%)

Completedn=89

(95%)

ATS2B 38

Amblyopic Eye Acuity at 4 Months2 Hours

Patching

N=92

6 Hours

Patching

N=89

Mean improvement from baseline 2.4 lines 2.4 lines

Mean acuity at 4 months

(Snellen approximation)20/32-2 20/32-2

>20/32 or >3 line improvement from baseline

62% 62%

ATS2B 39


20/32

20/40

20/50

20/63

20/80

20/63+20/63+

Mea

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Scor

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2 Hours N=95

6 Hours N=94

Baseline

20/40+20/40+

2 Hours N=87

6 Hours N=85

5 Weeks

20/32-220/32-2

2 Hours N=92

6 Hours N=89

4 Months

ATS2B 40

Amblyopia Treatment Index• Both treatments were well tolerated.

• The subscale scores were similar between the groups on the adverse event and treatment compliance subscales.

• On the social stigma subscale, which includes questions related to the patch making the child feel different, the 6-hour group was worse.

Median ScoreSubscale 2 Hours 6 HoursAdverse Effects 2.13 2.13



ATS2B 41

Summary2 vs. 6 hours for moderate amblyopia

• Amblyopia improved with both patching regimens, when combined with prescribing 1 hour of near activities

• There was no demonstrable advantage to the greater number of hours either in the rapidity or magnitude of improvement after 4 months of treatment

ATS2B 42

Summary - Adverse Effects

• We found no indication that 6 hours of patching compared with 2 hours of patching was associated with a higher rate of adverse effects on the sound eye acuity

• New heterotropias were rare

ATS2B 43

Conclusions

• When combined with prescribing 1 hour of near activities, 2 hours of daily patching appears to be as effective as 6 hours of daily patching in treating moderate amblyopia in children 3 to < 7 years of age

• A shorter duration of patching may ease the implementation of patching therapy and monitoring compliance for some parents

ATS2A 44

Results ATS 2A

6 hours vs. full time patching for severe amblyopia (20/100 – 20/400)

The Pediatric Eye Disease Investigator GroupA Randomized Trial of Prescribed Patching Regimens for Treatment of Severe Amblyopia in Children Ophthalmology 2003:11;2075-2087

ATS2A 45

Patient CharacteristicsN= 175

Female 46%

Caucasian 83%


Cause of Amblyopia

Strabismus 27%

Anisometropia 34%

Combined 38%


ATS2A 46

Patient Follow Up

6 Hour Groupn=85

Full-time Groupn=90

Patients Randomized

N=175

4-MONTHMASKED

EXAM

Completedn=73

(86%)

Completedn=84

(93%)

ATS2A 47

Amblyopic Eye Acuity at 4 Months

6 Hours

Patching

N=73

Full-time

Patching

N=84



(Snellen approximation)20/50 20/50-2

ATS2A 48


20/160

20/200

20/125

20/063

20/080

20/100

20/250

20/050

20/040

Mea

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core

Full-time N=90

Six-hrs N=85

Baseline Exam

20/16020/160+1

Full-time N=77

Six-hrs N=75

Five-week Exam

20/63-220/63-2

Full-time N=84

Six-hrs

N=73

Four-month Exam

20/5020/50-2

ATS2A 49

Treatment Effect in Subgroups at 4 Months

Effect of treatment was similar in subgroups based on:• Age:

– <5 years old, >5 years old


• Baseline visual acuity in amblyopic eye– 20/100 to 20/160 , 20/200 to 20/400

ATS2A 50

Amblyopia Treatment Index• Both treatments were well tolerated

• The subscale scores were similar between the groups on the adverse event, treatment compliance, and social stigma subscale subscales

Median ScoreSubscale 6 Hours Full-TimeAdverse Effects 2.25 2.50



ATS2A 51

Summary6 hrs vs. full-time for severe amblyopia

• Amblyopia improved with both prescribed patching regimens, when combined with prescribing 1 hour of near activities

• Compared to 6-hour patching, there was no demonstrable advantage to full-time patching in the rapidity or the magnitude of improvement after 4 months of treatment

52

Amblyopia Recurrence ATS 2C

• Prospective observational study

• 156 children with successfully treated amblyopia – ready to stop treatment

• Treatment STOPPED at enrollment

Risk of amblyopia recurrence after cessation of treatment.J AAPOS. 2004 Oct;8(5):420-8.

53

Previous Rx

Enrollment156 children

5w 13w 26w 52wStudy period – off treatment

Study Design

Treatment STOPPED

54

Recurrence overall during 1-year follow-up

Recurrence ( 2 logMAR -Confirmed by repeat testing)21% (95% CI 14% to 28%)

Alternative Definition – Non replicated 2 logMAR VA

No recurrenceAll recurrences - 24%(95% CI 17% to 32%)

21%

3%

55

Timing of the 35 recurrences

100

110

120

130

140

150

0 5 10 15 20 25 30 35 40 45 50

Pts

Weeks

14 (40%)

10 (29%)5 (14%)

6 (17%)

56

Patching vs Atropine

Patching Stopped (77% pts)

Atropine Stopped (23% pts)

25% Recurrence (95% CI 17% to 34%)

21% Recurrence (95% CI 7% to 35%)

57

Patching hours stopped

0%

20%

40%

60%

80%

100%

2h >2<6h 6-8h >8h

Patching hours stopped at enrollment

Recurrence 15% 18% 43% 43%

P=0.008

58

Conclusions of Amblyopia Recurrence Study

• ¼ of successfully amblyopic children experience a recurrence over 1 year of f/u

• Recurrence risk is similar for stopping patching and atropine

• Most recurrences occur within 3 months – early follow-up is critical – but long term follow-up is also important

• If 6 or more hours of patching stopped – recurrence risk is lower if patching is reduced to 2 hours per day before cessation – suggests “weaning” is beneficial

ATS3 59

An Evaluation of Treatment of Amblyopia in

Children 7-<18 Years Old – ATS3

Supported by the National Eye

Institute

ATS3PS 60

PEDIG Pilot Study

Eligibility • Age 10 to <18 years

• Amblyopic eye acuity of 20/40 to 20/160

Treatment • >2 hours daily patching

• At least one hour of near activities during patching

Outcome: Visual acuity after two months of treatment

Results: Visual acuity improved >2 lines in 18 (27%)

of 66 patients

A prospective, pilot study of treatment of amblyopia in children 10 to <18 years old.Am J Ophthalmol. 2004:137;581-583.

ATS3 61

•To determine the response rate to amblyopia treatment in children from 7 to <18 years

•To determine the frequency of recidivism of successfully-treated amblyopia in children 7 to <18 years

Objectives

ATS3 62

Eligibility

• Age 7 years to <18 years

• Amblyopia associated with strabismus, anisometropia, or both

• Best corrected visual acuity in the amblyopic eye 20/40 to 20/400

• Best corrected visual acuity in the sound eye 20/25 or better

• No myopia in amblyopic eye >-6.00 D spherical equivalent

• No amblyopia treatment (other than spectacles) in the past month and no more than one month of amblyopia treatment in the last 6 months

ATS3 63

•Randomized, controlled multi-center clinical trial

•Sample size: >360 children (>90 in each of 4 age groups)

•Treatment groups:

Control Group: Optical correction only

Active Group: Optical correction Patching plus near activities

Atropine (patients <13 yrs only)

•Primary analysis: Comparison of proportion of treatment

responders between treatment groups

Study Design

ATS3 64

Enrollment Prescription of spectacles

Randomization (within 30 days of enrollment)Visual acuity testing in new spectacles

Randomized Trial Follow Up

Post-randomized Trial Follow Up

Observation Phase Follow Up Treatment is discontinued

End of Study

NonrespondersResponders

Active Group Control Group

Study Flow

ATS3 65

Enrollment/Randomization

Screening/Enrollment Visit: • Patients are prescribed new spectacles (if needed)

Randomization Visit (within 1 month): • New spectacles are placed on patient for the first time

• Visual acuity is tested using E-ETDRS protocol, which yields a letter score

• Patient is randomized as long as visual acuity still meets eligibility criteria

ATS3 66

Treatment Groups

Patients are randomized to one of the following treatment

groups:

Control Group: • Optical correction only

Active Treatment Group: • Optical correction• Patching 2-6 hours daily• At least 1 hour of near activities daily during patching • Atropine 1% one drop daily (pts <13 yrs only)

ATS3 67

Randomized Trial Follow UpFollow-up visits occur every 6 weeks up to 24 weeks

• Visual acuity is tested with the E-ETDRS protocol

• Using the best of two measured amblyopic eye visual acuities, the patient is classified as a responder, nonresponder or neither

• When the patient meets criteria for either responder or non-responder and this is confirmed by masked exam, the randomized trial is over

ATS3 68

Responder/Nonresponder Criteria

Responder Criteria: 10 letter (2 line) or more improvement in amblyopic eye acuity compared with acuity at randomization

Nonresponder Criteria: minimal improvement that is visit specific, but less than 10 letters by 24 weeks

ATS3 69

Post-Randomized TrialNonresponders:

– End study follow up – Control group patients may start on active treatment outside study

Responders: – Continue assigned treatment until no further improvement– Once improvement has stopped:

• Control Group patients end study, but may start on active treatment outside study

• Active Treatment Group patients discontinue treatment and enter the Observation Phase

ATS3 70

Observation Phase Visits occur at 13 wks, 26 weeks, and 52 weeks after

treatment discontinuation

• Visual acuity is assessed at each visit

• Recurrence: acuity 10 or more letters worse than acuity at treatment discontinuation

71

RESULTS

• 507 patients

• 49 sites– 1 to 33 patients/per site

72

Patient Characteristics 7 < 13 YRSN=404 (%)

TREATMENT (N = 201) OPTICAL CORRECTION (N = 203)AGE 9.8 (1.6) 9.5 (1.7)FEMALE 89 (44) 87 (43)NO PRIOR TREATMENT 96 (48) 99 (49)CAUSE OF AMBLYOPIAStrabismus 52 (26) 52 (26)Anisometropia 75 (38) 81 (41)Combined 73 (37) 66 (33)ACUITY IN AMBLYOPIC EYE20/200 - 400 16 (8) 18 (9)20/100 – 160 44 (22) 48 (24)20/40 – 80 141 (70) 137 (67)

73

Patient Characteristics 13 < 18 YRSN=103 (%)

TREATMENT (N = 55) OPTICAL CORRECTION (N = 48)AGE 14.7 (1.4) 14.9 (1.2)FEMALE 31 (56) 25 (52)NO PRIOR TREATMENT 36 (65) 33 (69)CAUSE OF AMBLYOPIAStrabismus 11 (20) 14 (29)Anisometropia 20 (36) 17 (35)Combined 24 (44) 17 (35)ACUITY IN AMBLYOPIC EYE20/200 - 400 2 (4) 3 (6)20/100 – 160 20 (36) 16 (33)20/40 – 80 33 (60) 29 (60)

74

Responder Rate 7 < 13 YRS

TREATMENT (N = 201) OPTICAL CORRECTION (N = 203)TOTAL 106 (53) 50 (25)AMBLYOPIA LEVEL 20/40 – 80 (N 141/137) 70 (50) 30 (22)20/100-400 (N 60/66) 36 (60) 20 (30)

PRIOR AMBLYOPIA TREATMENTYes (N 105/104) 42 (40) 14 (13)No (N 96/99) 64 (67) 36 (36)

N (%)* All Statistically Different

75

Responder Rate 13 < 18 YRS

TREATMENT (N = 55) OPTICAL CORRECTION (N = 48)TOTAL 14 (25) 11 (23)AMBLYOPIA LEVEL 20/40 – 80 (N 33/29) 7 (21) 6 (21)20/100-400 (N 22/19) 7 (32) 5 (26)

PRIOR AMBLYOPIA TREATMENTYes (N 38/28) 6 (16) 7 (25)No (N 17/20) * 8 (47) * 4 (20) *

N (%)* Suggestive of Difference

76

Conclusions• Amblyopic vision improves with optical

correction alone in about ¼ of all 7 to 17 Year Olds and ½ of 7 to 12 years olds with additional treatment.

• Amblyopic vision improves in 7 to < 13 year old children but not 13 to < 18 year olds who have been treated previously.

• All amblyopic eyes have remaining visual deficit.• Persistence of effect after treatment cessation is

unknown.

77

Amblyopia Treatment Study 4

(ATS4) A Randomized Trial of

Atropine Regimens for Treatment of Moderate Amblyopia in Children

78

Study Objectives

• To compare daily versus weekend atropine (two-days) for moderate amblyopia (20/40 to 20/80) in children 3 to <7 years old

• To determine the maximum amount of improvement that could be achieved with these atropine schedules.

79

Study Design

• A randomized, controlled, single-masked multi-center clinical trial

• 2 treatment groups:

• Primary outcome: Visual acuity at 4 months

• Secondary outcome: Maximum visual acuity improvement

daily atropine

weekend atropine

80

Eligibility

• Age < 7 years

• Able to measure visual acuity with single surrounded HOTV optotypes


• No amblyopia treatment in the past month and no more than 1 month of amblyopia treatment in the past six months

81

EligibilityVisual Acuity

• Amblyopic eye - 20/40 to 20/80

• Sound eye - > 20/40

• Inter-eye acuity difference - > 3 lines

82

Atropine Treatment

• weekend or daily atropine 1% solution was prescribed

• For patients in the daily atropine group, if the amblyopic eye acuity improved to be the same as or better than the sound eye acuity, atropine could be decreased to no less than twice per week

83

Visit Schedule

• 5-week visit

• Masked outcome visit at 4 months– Amblyopic eye at 17 weeks, sound eye and

binocularity at 19 weeks

• Additional visits at investigator discretion

• Partial responders returned every 8 weeks

84

Patient CharacteristicsN=168

Female 39%

Caucasian 79%


Cause of Amblyopia

Strabismus 33%

Anisometropia 41%

Combined 23%


85

Patient Follow-Up

Weekend Groupn=85

Daily Groupn=83

Patients Randomized

N=168

4-MONTHMASKED

EXAM

Completedn=83

(98%)

Completedn=77

(93%)

86

Amblyopic Eye at 4 Months

Weekend atropine

N=83

Daily atropine

N=77



(Snellen approximation)20/32-1 20/32-1

>20/32 or >3 line improvement from baseline

66% 66%

87

0%

20%

40%

60%

80%

100%

6-Hours Patching

0%

20%

40%

60%

80%

100% 2-Hours Patching

Amblyopic Eye at 4 MonthsA

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>20/16

>20/20

>20/25

>20/32

>20/40

>20/50

>20/63

>20/80

>20/100

>20/125

>20/160

N=92

N=89

0%

20%

40%

60%

80%

100%

Weekend Atropine

0%

20%

40%

60%

80%

100%

Daily Atropine

N=77

N=83

88

5 Weeks

20/40+120/40


20/32

20/40

20/50

20/63Mea

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Scor

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DailyN=83

WeekendN=85

Baseline

Daily N=78

Weekend N=81

DailyN=77

WeekendN=83

20/63+220/63+2

4 Months

20/32-120/32-1

89

Acuity at Study Completion

• 20/25 or better OR equal to sound eye– Daily - 39 (47%) – Weekend - 45 (53%)

• Mean Amblyopic eye acuity– Daily – 0.23 logMAR (20/32-3)

• 2.3 lines of improvement

– Weekend – 0.21 log MAR (20/32-1) • 2.5 lines of improvement

90

Treatment Effect in Subgroups

• Effect of treatment was similar in subgroups based on:

• Age: – <5 years old, >5 years old


• Baseline visual acuity in amblyopic eye– <20/63, >20/50

91

Effect of Treatment on the Sound Eye

• A decrease in sound eye visual acuity of 2 or more lines at 4 months:

Weekend atropine - 2 patients (2.4%) Daily atropine - 2 patients (2.6%)

• Further Follow-up Testing:• One in each group same as or better than

baseline• One in each group 20/32 compared with 20/20

at baseline

92

Other adverse effects

• Light sensitivity (no treatment changes)– Daily group – 13 (16%)– Weekend group – 25 (29%)

• Facial flushing / fever– 2 patients in daily group – 1 stayed on

treatment and 1 switched to homatropine

93

Ocular alignment

• 2 in daily and none in weekend developed > 8 deviation

• 2 in daily, 3 in weekend had disappearance of a microstrabismus

• 10% developed new strabismus or a preexisting angle of strabismus that had increased by at least 10

• 8% had their strabismus resolved or reduced by at least 10

94

Amblyopia Treatment Index• Both treatments were well tolerated.

• The subscale scores were similar between the groups on the adverse event and social stigma subscales.

• On the compliance subscale the weekend group was slightly worse.

Median ScoreSubscale Weekend DailyAdverse Effects 2.00 2.00



95

Conclusions

• Weekend atropine appears to be as effective as daily atropine in treating moderate amblyopia in children 3 to < 7 years of age

• A reduced frequency is another alternative treatment for amblyopia.

• The magnitude of the visual acuity improvement was similar to that seen for 2-hour and 6-hour prescribed patching regimens for moderate amblyopia.

1 Evidence Based Treatment of Amblyopia in 2005 What we have learnt from the Pediatric Eye Disease...

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