Binocular Treatment of Amblyopia Before and After Strabismus Surgery

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT01791946
First received: February 7, 2013
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Amblyopia
Strabismus
Procedure: Binocular Treatment Training
Procedure: Sham Binocular Treatment Training

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Binocular Treatment of Amblyopia Before and After Strabismus Surgery

Resource links provided by NLM:


Further study details as provided by Massachusetts Eye and Ear Infirmary:

Primary Outcome Measures:
  • 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. [ Time Frame: This is a change outcome measure. That is measurements will be taken at baseline, 6 weeks, and approximately 3 months. ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: January 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Group A (Post-Surgery Treatment)
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 Training
The binocular treatment training 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.
Experimental: Treatment Group B (Pre-Surgery Treatment)
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 Training
The binocular treatment training 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.
Sham Comparator: Sham Treatment
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 Training
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01791946

Locations
United States, Massachusetts
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Investigators
Principal Investigator: Dean Cestari, M.D. Massachusetts Eye and Ear Infirmary
  More Information

Publications:
Responsible Party: Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT01791946     History of Changes
Other Study ID Numbers: 12-186H
Study First Received: February 7, 2013
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts Eye and Ear Infirmary:
lazy eye
cross eye
cross eyed

Additional relevant MeSH terms:
Amblyopia
Strabismus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Ocular Motility Disorders
Cranial Nerve Diseases

ClinicalTrials.gov processed this record on September 15, 2014