Trial Comparing Patching Versus Atropine for Amblyopia in 7 to < 13 Year Olds - Full Text View

Sponsor:	Jaeb Center for Health Research
Collaborator:	National Eye Institute (NEI)
Information provided by:	Jaeb Center for Health Research
ClinicalTrials.gov Identifier:	NCT00315328

Purpose

The purpose of this study is:

To compare the effectiveness of weekend atropine plus near activities and daily patching plus near activities for moderate amblyopia (20/40 to 20/100) and severe amblyopia (20/125 to 20/400) in improving vision in the amblyopic eye of 7 to <13 year olds.
To determine the maximum improvement in vision of the amblyopic eye with each treatment.
To determine whether amblyopia is associated with structural abnormalities of optic nerve fiber layer.

Condition	Intervention	Phase
Amblyopia	Drug: Atropine Device: Patching Procedure: Near activities	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized Trial Comparing Patching Versus Atropine for Amblyopia in 7 to < 13 Year Olds

Resource links provided by NLM:

Drug Information available for: Atropine Atropine sulfate

U.S. FDA Resources

Further study details as provided by Jaeb Center for Health Research:

Primary Outcome Measures:

Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.
Mean Visual Acuity in the Amblyopic Eye at 17 Weeks [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.
Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks [ Time Frame: Baseline to 17 weeks ] [ Designated as safety issue: No ]
Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated.

A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks.
Mean Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks [ Time Frame: Baseline to 17 weeks ] [ Designated as safety issue: No ]
Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated.

A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks.

Secondary Outcome Measures:

Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia [ Time Frame: 17 or 19 weeks ] [ Designated as safety issue: Yes ]
The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only [ Time Frame: 17 or 19 weeks ] [ Designated as safety issue: Yes ]
The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism [ Time Frame: 17 or 19 weeks ] [ Designated as safety issue: Yes ]
The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia [ Time Frame: 17 or 19 weeks ] [ Designated as safety issue: Yes ]
Stereoacuity is scored as seconds of arc with values of: <800, 800, 400, 200, 100, 60, 40. The lower the arc second value, the better the score (i.e. 40 arc sec is best stereoacuity; <800 is the worst). A change score was defined as the difference between baseline and outcome in score level (i.e. moving from 800 at baseline to 400 at outcome is one level change, moving from 800 to 200 is two levels, etc.) change in levels was categorized as "within one level" meaning change was -1, 0, or +1.
Amblyopia Treatment Index - Social Stigma (Moderate Amblyopia Only) [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
Questionnaire scores on the Social Stigma subscale of the Amblyopia Treatment Index. Questions were evaluated on a likert type scale as strongly agree (5) to strongly disagree (1), with a higher number indicating worse response.
Amblyopia Treatment Index - Compliance (Moderate Amblyopia Only) [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
Questionnaire scores on the compliance subscale of the Amblyopia Treatment Index. Questions were evaluated on a likert type scale as strongly agree (5) to strongly disagree (1), with a higher number indicating worse response.
Amblyopia Treatment Index - Adverse Effects Scale (Moderate Amblyopia Only) [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
Questionnaire scores on the adverse events subscale of the Amblyopia Treatment Index. Questions were evaluated on a likert type scale as strongly agree (5) to strongly disagree (1), with a higher number indicating worse response.
Distribution of Visual Acuity in the Fellow Eye at 17 Weeks [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.
Mean Visual Acuity in the Fellow Eye at 17 Weeks [ Time Frame: 17 weeks ] [ Designated as safety issue: Yes ]
Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.
Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks [ Time Frame: Baseline to 17 weeks ] [ Designated as safety issue: Yes ]
Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated.

A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks.
Mean Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks [ Time Frame: Baseline to 17 weeks ] [ Designated as safety issue: Yes ]
Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated.

A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks.

Enrollment:	233
Study Start Date:	August 2005
Study Completion Date:	January 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Patching Patching 2 hours per day plus near activities for one hour while patching (with increase to 4 hours per day for moderate amblyopes and >4 hours per day for severe amblyopes at 5 weeks if acuity not improved at least 5 letters)	Device: Patching Patching 2 hours per day Other Name: Coverlet, 3M Opticlude, Ortopad® Procedure: Near activities near visual activities for at least one hour per day
Active Comparator: Atropine Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day (with increase to daily atropine at 5 weeks if acuity not improved by at least 5 letters)	Drug: Atropine Atropine 1% each weekend day in the sound eye Other Name: Atropine Procedure: Near activities near visual activities for at least one hour per day

Show Detailed Description

Eligibility

Ages Eligible for Study:	7 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 7 to 12 years old (inclusive)
Amblyopia associated with strabismus, anisometropia, or both
Visual acuity in the amblyopic eye 19 to 71 letters on Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS©) (20/40 to 20/400 inclusive)
Visual acuity in the sound eye 79 letters or better on E-ETDRS© (20/25 or better)
Interocular difference >=15 letters (3 lines)
Spectacles, if needed, worn for at least 16 weeks or visual acuity documented to be stable

Inclusion Criteria for Optional Ancillary Study:

Enrolled into the main study
Refractive error in both eyes between -0.25 and +5.00D, inclusive (to avoid the need to adjust for refractive error)
Birth weight >1500 grams
No history of Central Nervous System (CNS) disease (e.g. intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), meningitis, developmental abnormalities of the brain, hydrocephalus, cerebral palsy, hypoxic ischemic encephalopathy

Exclusion Criteria:

Amblyopia treatment (other than spectacles) in the last 6 months
Myopia (more than -0.25D spherical equivalent) in either eye

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315328

Locations

United States, Pennsylvania
Pennsylvania College of Optometry
Philadelphia, Pennsylvania, United States, 19141
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

Jaeb Center for Health Research

National Eye Institute (NEI)

Investigators

Study Chair:	Richard W. Hertle, M.D.	Children's Hospital of Pittsburgh
Study Chair:	Mitchell M. Scheiman, O.D.	Pennsylvania College of Optometry

More Information

Additional Information:

PEDIG public website This link exits the ClinicalTrials.gov site

Publications:

Scheiman MM, Hertle RW, Kraker RT, Beck RW, Birch EE, Felius J, Holmes JM, Kundart J, Morrison DG, Repka MX, Tamkins SM; Pediatric Eye Disease Investigator Group. Patching vs atropine to treat amblyopia in children aged 7 to 12 years: a randomized trial. Arch Ophthalmol. 2008 Dec;126(12):1634-42.

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.

Repka MX, Kraker RT, Tamkins SM, Suh DW, Sala NA, Beck RW; Pediatric Eye Disease Investigator Group. Retinal nerve fiber layer thickness in amblyopic eyes. Am J Ophthalmol. 2009 Jul;148(1):143-7. Epub 2009 Mar 27.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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:	Boy W. Beck, M.D., Ph.D., Executive Director, Jaeb Center for Health Research
ClinicalTrials.gov Identifier:	NCT00315328 History of Changes
Other Study ID Numbers:	NEI-119, 2U10EY011751
Study First Received:	April 14, 2006
Results First Received:	September 9, 2009
Last Updated:	June 6, 2011
Health Authority:	United States: Federal Government; United States: Food and Drug Administration

Keywords provided by Jaeb Center for Health Research:

Amblyopia
Atropine
Patching

Additional relevant MeSH terms:

Amblyopia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Atropine
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents

Cardiovascular Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 07, 2012