Macular Hole Surgery With and Without Internal Limiting Membrane Peeling：A Systematic Review and Meta-analysis

NCT ID: NCT01687829

Last Updated: 2014-02-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-05-31

Brief Summary

Since Kelly and Wendel first reported successful closure of idiopathic macular holes (MH) by vitrectomy in 1991, many surgical modifications have been made to improve the anatomical and visual outcomes of this surgery. Recently, internal limiting membrane (ILM) peeling has become used widely as an adjunctive procedure during MH surgery because the removal of ILM is thought to reduce the tangential traction on the macula, a major factor in the pathogenesis of idiopathic macular holes. However, the role of ILM peeling in macular hole surgery is not yet well defined. To the best of our knowledge, there is no meta-analysis on comparison of the efficacy of ILM peeling and suture for MH surgery. This study reviewed the published literature comparing surgical results with and without ILM peeling and and performed a meta-analysis to determine whether there is any benefit or detriment anatomically and/or visually.

Conditions

Macular Holes

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

ILM-on group

patients were scheduled to undergo macular hole surgery without internal limiting membrane (ILM) peeling

No interventions assigned to this group

ILM-off group

patients were scheduled to undergo macular hole surgery with internal limiting membrane (ILM) peeling

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Eligible participants are those with idiopathic FTMH in stages 2-3, of less or equal than 18 months duration (based on symptoms reported by the patient) and with a visual acuity equal to or worse than 20/40 in the study eye.

Exclusion Criteria

• Patients with idiopathic FTMH stages 2-3 but longer than 18 months duration or with other causes of decreased vision (e.g. corneal scarring, age-related macular degeneration, diabetic retinopathy, glaucoma if central and/or paracentral absolute visual field defects are present) and
• Those with FTMH related to high myopia (> 6 dioptres) or trauma will be excluded from the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wenzhou Medical University

OTHER

Sponsor Role: collaborator

Yifan Feng

OTHER

Sponsor Role: lead

Responsible Party

Yifan Feng

Eye Hospital, Wenzhou Medical College, China

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yifan Feng, MD

Role: PRINCIPAL_INVESTIGATOR

Wenzhou Medical University

Locations

Wenzhou Medical College

Wenzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Yifan Feng, MD

Role: primary

wzafengyifan@163.com

+86-577-88068880

Other Identifiers

F20120913

Identifier Type: -

Identifier Source: org_study_id