Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye for Amblyopia in Children 3 to <7 Years Old (ATS8)

This study has been completed.

Sponsor:

Collaborator:

National Eye Institute (NEI)

Information provided by (Responsible Party):

Ray Kraker, Jaeb Center for Health Research

ClinicalTrials.gov Identifier:

NCT00315302

First received: April 14, 2006

Last updated: May 16, 2012

Last verified: May 2012

History of Changes

Results First Received: August 3, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Amblyopia
Interventions:	Drug: Atropine Device: Plano Lens

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between Feb 2005 and May 2007, 240 subjects were randomized at 30 sites (180 with moderate amblyopia 20/40 to 20/100 in a primary cohort, and an additional 60 with severe amblyopia 20/125 to 20/400 that were followed as a secondary cohort).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects must have had stable visual acuity in glasses (if applicable) before enrollment and randomization.

Reporting Groups

	Description
Atropine-Moderate Amblyopia	Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
Atropine Plus Plano-Moderate Amblyopia	Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
Atropine-Severe Amblyopia	Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
Atropine Plus Plano-Severe Amblyopia	Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)

Participant Flow: Overall Study

	Atropine-Moderate Amblyopia	Atropine Plus Plano-Moderate Amblyopia	Atropine-Severe Amblyopia	Atropine Plus Plano-Severe Amblyopia
STARTED	90	90	26	34
5 Week Visit	85	86	26	30
10 Week Visit	86 ^[1]	85	24	29
18 Week Primary Outcome Visit	84	88 ^[2]	24	31 ^[2]
Partial Responder Phase (Post 18 Weeks)	16 ^[3]	13 ^[3]	9 ^[3]	11 ^[3]
COMPLETED	84 ^[4]	88 ^[4]	24 ^[4]	31 ^[4]
NOT COMPLETED	6	2	2	3

[1]	Can be higher as includes subjects who may have missed the 5 week visit
[2]	Can be higher as includes subjects who may have missed the 10 week or other visit
[3]	Those who improved in the amblyopic eye at 18wk outcome continued on treatment w/ visits every 8wks.
[4]	Completed defined as completing 18 week primary outcome exam

Baseline Characteristics

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Reporting Groups

	Description
Atropine-Moderate Amblyopia	Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
Atropine Plus Plano-Moderate Amblyopia	Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
Atropine-Severe Amblyopia	Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
Atropine Plus Plano-Severe Amblyopia	Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
Total	Total of all reporting groups

Baseline Measures

	Atropine-Moderate Amblyopia	Atropine Plus Plano-Moderate Amblyopia	Atropine-Severe Amblyopia	Atropine Plus Plano-Severe Amblyopia	Total
Number of Participants [units: participants]	90	90	26	34	240
Age ^[1] [units: participants]
<=18 years	90	90	26	34	240
Between 18 and 65 years	0	0	0	0	0
>=65 years	0	0	0	0	0
Age ^[1] [units: years] Mean ± Standard Deviation	5.2 ± 1.1	5.1 ± 1.0	4.5 ± 0.9	4.4 ± 1.0	5.0 ± 1.1
Gender [units: participants]
Female	47	47	8	16	118
Male	43	43	18	18	122
Race/Ethnicity, Customized [units: Participants]
White	75	70	23	28	196
African-American	1	4	1	3	9
Hispanic or Latino	12	14	2	3	31
Asian	1	2	0	0	3
Unknown / Not reported	1	0	0	0	1
Region of Enrollment [units: participants]
United States	89	90	26	34	239
Canada	1	0	0	0	1
Cause of Amblyopia [units: participants]
Strabismus	38	37	10	11	96
Anisometropia	32	30	5	8	75
Strabismus and anisometropia	20	23	11	15	69
Distance Visual Acuity in Amblyopic Eye ^[2] [units: participants]
20/400 (worse)	0	0	0	8	8
20/320	0	0	8	2	10
20/250	0	0	1	3	4
20/200	0	0	5	5	10
20/160	0	0	5	5	10
20/125	0	0	7	11	18
20/100	7	15	0	0	22
20/80	14	15	0	0	29
20/63	29	28	0	0	57
20/50	24	17	0	0	41
20/40 (better)	16	15	0	0	31
Distance Visual Acuity in Sound Eye ^[2] [units: participants]
20/40 (worse)	3	3	4	7	17
20/32	18	18	11	12	59
20/25	27	28	8	7	70
20/20	31	33	3	8	75
20/16 (better)	11	8	0	0	19
Prior Treatment for Amblyopia at Enrollment [units: participants]
None	76	72	24	28	200
Patching	9	12	1	6	28
Atropine	1	2	0	0	3
Patching and Atropine	4	4	1	0	9
Refractive Error in Amblyopic Eye (spherical equivalent/diopters) ^[3] [units: participants]
0 to < +1.00 D	1	0	0	0	1
+1.00 to < +2.00 D	0	6	1	0	7
+2.00 D to < +3.00 D	8	6	3	0	17
+3.00 D to < +4.00 D	13	15	3	4	35
>= +4.00 D	68	63	19	30	180
Refractive Error in Sound Eye (spherical equivalent/diopters) ^[3] [units: participants]
+ 1.50 to < + 2.00 D	17	23	6	6	52
+ 2.00 D to < + 3.00 D	14	19	8	5	46
+3.00 D to < + 4.00 D	20	12	2	8	42
>= + 4.00 D	39	36	10	15	100
Distance Visual Acuity in Amblyopic Eye ^[2] [units: log of min angle of resolution (logMAR)] Mean ± Standard Deviation	0.47 ± 0.12	0.50 ± 0.13	0.99 ± 0.16	1.01 ± 0.20	0.61 ± 0.27
Distance Visual Acuity in Sound Eye ^[2] [units: log of min angle of resolution (logMAR)] Mean ± Standard Deviation	0.07 ± 0.10	0.07 ± 0.10	0.16 ± 0.09	0.15 ± 0.11	.09 ± .11
Intereye Acuity Difference ^[4] [units: logMAR lines] Mean ± Standard Deviation	4.0 ± 1.2	4.3 ± 1.3	8.3 ± 1.7	8.6 ± 2.2	5.2 ± 2.4
Refractive Error in Amblyopic Eye (spherical equivalent/diopters) ^[3] [units: diopters] Mean ± Standard Deviation	4.99 ± 1.66	4.94 ± 1.81	5.25 ± 2.09	5.36 ± 1.29	5.05 ± 1.72
Refractive Error in Sound Eye (spherical equivalent/diopters) ^[3] [units: diopters] Mean ± Standard Deviation	3.71 ± 1.71	3.54 ± 1.86	3.60 ± 2.18	3.71 ± 1.58	3.63 ± 1.79

[1]	Age at enrollment
[2]	Visual acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at 18 weeks resulting in a Snellen acuity score that can range from 20/16 to 20/800. This visual acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis. 20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst
[3]	Measured in diopters (D) using cycloplegic refraction sphere, cylinder, and axis. Spherical equivalent is defined as the sphere plus 1/2 the cylinder.
[4]	Intereye difference defined as the difference between logMAR scores (amblyopic eye minus sound eye)

Outcome Measures

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1. Primary:

Visual Acuity Mean Score in the Amblyopic Eye [ Time Frame: 18 weeks ]

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2. Primary:

Visual Acuity Distribution in the Amblyopic Eye [ Time Frame: 18 weeks ]

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3. Primary:

Mean Change in Visual Acuity in the Amblyopic Eye [ Time Frame: baseline to 18 weeks ]

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4. Primary:

Distribution of Change in Visual Acuity in the Amblyopic Eye [ Time Frame: baseline to 18 weeks ]

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5. Secondary:

Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia [ Time Frame: 18 weeks ]

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6. Secondary:

Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only [ Time Frame: 18 weeks ]

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7. Secondary:

Mean Change in Visual Acuity in the Sound Eye [ Time Frame: baseline to 18 weeks ]

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8. Secondary:

Distribution of Change in Visual Acuity in the Sound Eye [ Time Frame: baseline to 18 weeks ]

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9. Secondary:

Visual Acuity Distribution in the Sound Eye [ Time Frame: 18 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Raymond Kraker
Organization: Jaeb Center for Health Research
phone: 813-975-8690
e-mail: pedig@jaeb.org

Publications of Results:

Pediatric Eye Disease Investigator Group. Pharmacological plus optical penalization treatment for amblyopia: results of a randomized trial. Arch Ophthalmol. 2009 Jan;127(1):22-30.

Other Publications:

Repka MX, Kraker RT, Beck RW, Birch E, Cotter SA, Holmes JM, Hertle RW, Hoover DL, Klimek DL, Marsh-Tootle W, Scheiman MM, Suh DW, Weakley DR; Pediatric Eye Disease Investigator Group. Treatment of severe amblyopia with weekend atropine: results from 2 randomized clinical trials. J AAPOS. 2009 Jun;13(3):258-63.

Publications automatically indexed to this study:

Wallace DK, Lazar EL, Melia M, Birch EE, Holmes JM, Hopkins KB, Kraker RT, Kulp MT, Pang Y, Repka MX, Tamkins SM, Weise KK; Pediatric Eye Disease Investigator Group. Stereoacuity in children with anisometropic amblyopia. J AAPOS. 2011 Oct;15(5):455-61.

Repka M, Simons K, Kraker R; Pediatric Eye Disease Investigator Group. Laterality of amblyopia. Am J Ophthalmol. 2010 Aug;150(2):270-4. Epub 2010 May 8.

Responsible Party:	Ray Kraker, Jaeb Center for Health Research
ClinicalTrials.gov Identifier:	NCT00315302 History of Changes
Other Study ID Numbers:	NEI-115, 2U10EY011751
Study First Received:	April 14, 2006
Results First Received:	August 3, 2009
Last Updated:	May 16, 2012
Health Authority:	United States: Federal Government United States: Food and Drug Administration

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