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

NCT02113709 | Unknown DMC

• 1 other identifier: SIrfanMEHT
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Amblyopia; Strabismus

Keywords

Amblyopia; Strabismus; Occlusion therapy; Visual improvement

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (1)

• improvement in stereopsis

  1 year

Other Outcomes (1)

• Does the patched good eye develop occlusion amblyopia

  3 months

Study Arms (1)

Visual improvement

EXPERIMENTAL

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

Device: Occlusion therapy by Eye Patch; Device: Occlusion therapy

Interventions

Occlusion therapy by Eye Patch DEVICE

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.

Visual improvement

Occlusion therapy DEVICE

To see how much improvement in visual acuity occurs by full-time occlusion therapy.

Also known as: eye patch (commercially pre-packed)

Visual improvement

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mughal Eye Trust Hospital: lead

Study Sites (1)

Mughal Eye Trust Hospital

Lahore, Punjab Province, 54770, Pakistan

Location

MeSH Terms

Conditions

Amblyopia; Strabismus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Ocular Motility Disorders; Cranial Nerve Diseases

Study Officials

• Sameera Irfan, FRCS

  Mughal Eye Trust Hospital, Lahore, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Ophthalmologist

Study Record Dates

• First Submitted: March 29, 2014
• First Posted: April 15, 2014
• Study Start: January 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: June 1, 2014
• Last Updated: April 15, 2014

Record last verified: 2014-04

Locations

PA (1)