Binocular Treatment of Amblyopia Before and After Strabismus Surgery

NCT01791946 | Completed

• 1 other identifier: 12-186H
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to assess the effectiveness of an investigational binocular treatment in improving vision in strabismic amblyopes (i.e., patients with lazy eye, or poor vision in one eye due to a present or former eye misalignment). Patients will be randomized to receive the study treatment either before or after strabismus surgery (i.e., corrective eye alignment surgery) or sham treatment before surgery. The study hypothesis is that there will be no significant change in vision in neither the pre nor post-surgery groups and no significant change in vision in neither the sham nor actual treatment groups.

Conditions

Amblyopia; Strabismus

Keywords

lazy eye; cross eye; cross eyed

Outcome Measures

Primary Outcomes (1)

• The primary outcome variable is a composite of the difference in visual acuity and stereo vision measurements taken before binocular treatment and strabismus surgery versus after binocular treatment and strabismus surgery.

  This is a change outcome measure. That is measurements will be taken at baseline, 6 weeks, and approximately 3 months.

Study Arms (3)

Treatment Group A (Post-Surgery)

EXPERIMENTAL

Subjects enrolled in this arm will first have eye alignment corrective surgery and then complete six weeks of the investigational binocular treatment training.

Procedure: Binocular Treatment

Treatment Group B (Pre-Surgery)

EXPERIMENTAL

Subjects enrolled in this arm will first complete six weeks of the investigational binocular treatment training and then have eye alignment corrective surgery.

Procedure: Binocular Treatment

Sham Treatment

SHAM COMPARATOR

Subjects enrolled in this arm will first complete six weeks of the sham binocular treatment and then undergo eye alignment corrective surgery.

Procedure: Sham Binocular Treatment

Interventions

Binocular Treatment PROCEDURE

The binocular treatment involves the completion of visual tasks via virtual reality goggles. The stimulus is presented to each eye separately, allowing for varying levels of contrast to be presented to each eye. (The visual task is therefore made more or less difficult with the variation of contrast presented to either eye.) Subjects will complete the computer-based visual tasks for approximately 36 hours total over the course of six weeks, or six hours per week for six weeks.

Treatment Group A (Post-Surgery); Treatment Group B (Pre-Surgery)

Sham Binocular Treatment PROCEDURE

The sham treatment involves the same computer-based visual tasks and timeframe as the binocular treatment training but there will be no variation in contrast presentation to either eye.

Sham Treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Presence of amblyopia in one eye due to congenital strabismus.
• Amblyopic eye has a fully-corrected visual acuity of 20/30 or less with no other cause for the visual loss except amblyopia.
• Patient is 18 to 60 years old.
• Corrected vision in other eye is normal.
• Eligible for strabismus surgery or has completed it previously with a successful outcome, as determined by the treating physician.
• Available and willing to comply with examination procedures and schedule.
• Signed and dated informed consent.

You may not qualify if:

• Fully-corrected visual acuity of less than 20/30 in both eyes.
• Visual decrement due to anything other than amblyopia.
• At high risk for developing intractable diplopia (double vision) if vision in weak eye is improved. (To be determined by treating physician.)
• Unable or unavailable to complete at least 18 hours of binocular treatment over the course of six weeks.
• Currently enrolled in another research study.

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead

Study Sites (1)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

• Hess RF, Mansouri B, Thompson B. Restoration of binocular vision in amblyopia. Strabismus. 2011 Sep;19(3):110-8. doi: 10.3109/09273972.2011.600418.

  PMID: 21870914 RESULT

• Hess RF, Mansouri B, Thompson B. A new binocular approach to the treatment of amblyopia in adults well beyond the critical period of visual development. Restor Neurol Neurosci. 2010;28(6):793-802. doi: 10.3233/RNN-2010-0550.

  PMID: 21209494 RESULT

MeSH Terms

Conditions

Amblyopia; Strabismus; Esotropia

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

• Dean Cestari, M.D.

  Massachusetts Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2013
• First Posted: February 15, 2013
• Study Start: January 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 13, 2017

Record last verified: 2015-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)