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Determining the Efficacy of Full-time Occlusion Therapy in Severe Amblyopia at Different Ages

Primary Purpose

Amblyopia, Strabismus

Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Occlusion therapy by Eye Patch
Occlusion therapy
Sponsored by
Mughal Eye Trust Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amblyopia focused on measuring Amblyopia, Strabismus, Occlusion therapy, Visual improvement

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • a visual acuity of 6/60 or 0.1-0.2 ETDRS in one eye and 6/6 or 1.0 ETDRS in the good eye
  • strabismic amblyopia
  • patients of any age were included.

Exclusion Criteria:

  • structural damage to the eye (organic amblyopia)
  • ametropic amblyopia

Sites / Locations

  • Mughal Eye Trust Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Visual improvement

Arm Description

To see how efficiently visual improvement occurs by Full-time Occlusion therapy with an eye patch in severe amblyopia.

Outcomes

Primary Outcome Measures

Visual Acuity improvement
Full-time occlusion therapy of good eye was performed for 2-3 months while closely monitoring the vision of both the good and the amblyopic eye. Vision was assessed by EDTRS Charts as well as Snellen's Chart.

Secondary Outcome Measures

improvement in stereopsis
as equal visual acuity is attained by both eyes, the stereopsis also improves. It was assessed by satandardized TNO plates with the patient wearing polarized glasses over their own corrective spectacles.

Full Information

First Posted
March 29, 2014
Last Updated
April 14, 2014
Sponsor
Mughal Eye Trust Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02113709
Brief Title
Determining the Efficacy of Full-time Occlusion Therapy in Severe Amblyopia at Different Ages
Official Title
Determining the Efficacy of Full-time Occlusion Therapy in Severe Amblyopia at All Ages
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mughal Eye Trust Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Objective: To find out how much visual improvement is possible in severe amblyopia using full-time occlusion therapy with an eye patch and to see if improvement is influenced by the patient's age. Methods: An interventional clinical trial of 115 consecutive cases with unilateral, severe amblyopia was conducted at a tertiary referral center from Jan 2010 to Oct 2012. Patients were divided into three age groups: 3-7 years (n= 38), 8-12 years (n=41), 13-35 years (n=36). After a complete ophthalmological examination by a single ophthalmologist, cases with organic visual loss were excluded; cases with previous part-time occlusion therapy that had failed were included in the study. Patients were given optimal refractive correction for a month, followed by full-time occlusion therapy along with near visual activities for 3-4 hours/day. The therapy was continued until maximum visual recovery was achieved (6/6 Snellen's). Therapy was gradually reduced and stopped. Patients were followed-up regularly for the next 18 months.
Detailed Description
Amblyopia, ('blunt vision' in Ancient Greek), also known as lazy eye, is a visual deficiency in an eye that is otherwise physically normal, or that is greater than would be expected from any structural abnormalities of the eye. There are unsubstantiated beliefs that it is more difficult to treat amblyopia in older age groups, that children that have already received failed amblyopia therapy do not respond to treatment and that full-time occlusion therapy may result in occlusion (disuse) amblyopia of the good eye. The aim of this study was to assess whether these beliefs are true. Materials and methods This was a prospective, interventional clinical trial of 115 consecutive cases with unilateral, severe amblyopia conducted at a tertiary referral center in Lahore, Pakistan, from January 2010 to October 2012. Eligibility criteria included an age of over three years, visual acuity in the amblyopic eye from 6/60 Snellen's or even counting fingers only, visual acuity in the sound eye of 6/6. A complete ophthalmic examination was performed by only one ophthalmologist (SI). This included examining the fixation pattern of both eyes, presence or absence of a phoria or a tropia by a cover-uncover test, fundus examination and color vision using Ishihara color plates. Any case with an organic cause for visual loss was excluded from the study after a thorough ophthalmological examination. Assessment of visual acuity of either eye for both near and distance acuity (Snellen's and ETDRS charts) refraction and Best Corrected Visual Acuity (BCVA) was performed by a trained optician who was masked to the study and patient's demographics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia, Strabismus
Keywords
Amblyopia, Strabismus, Occlusion therapy, Visual improvement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Visual improvement
Arm Type
Experimental
Arm Description
To see how efficiently visual improvement occurs by Full-time Occlusion therapy with an eye patch in severe amblyopia.
Intervention Type
Device
Intervention Name(s)
Occlusion therapy by Eye Patch
Intervention Description
The good eye was occluded by a stick-on eye patch to stimulate the amblyopic eye and its neural connections to learn to see again.
Intervention Type
Device
Intervention Name(s)
Occlusion therapy
Other Intervention Name(s)
eye patch (commercially pre-packed)
Intervention Description
To see how much improvement in visual acuity occurs by full-time occlusion therapy.
Primary Outcome Measure Information:
Title
Visual Acuity improvement
Description
Full-time occlusion therapy of good eye was performed for 2-3 months while closely monitoring the vision of both the good and the amblyopic eye. Vision was assessed by EDTRS Charts as well as Snellen's Chart.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
improvement in stereopsis
Description
as equal visual acuity is attained by both eyes, the stereopsis also improves. It was assessed by satandardized TNO plates with the patient wearing polarized glasses over their own corrective spectacles.
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Does the patched good eye develop occlusion amblyopia
Description
The vision of patched good eye was meticulously monitored to note the development of occlusion amblyopia
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: a visual acuity of 6/60 or 0.1-0.2 ETDRS in one eye and 6/6 or 1.0 ETDRS in the good eye strabismic amblyopia patients of any age were included. Exclusion Criteria: structural damage to the eye (organic amblyopia) ametropic amblyopia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameera Irfan, FRCS
Organizational Affiliation
Mughal Eye Trust Hospital, Lahore, Pakistan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mughal Eye Trust Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54770
Country
Pakistan

12. IPD Sharing Statement

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Determining the Efficacy of Full-time Occlusion Therapy in Severe Amblyopia at Different Ages

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