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

Y

Yifan Feng

Status

Unknown

Conditions

Macular Holes

Study type

Observational

Funder types

Other

Identifiers

NCT01687829
F20120913

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

400 participants in 2 patient groups

ILM-on group
Description:
patients were scheduled to undergo macular hole surgery without internal limiting membrane (ILM) peeling
ILM-off group
Description:
patients were scheduled to undergo macular hole surgery with internal limiting membrane (ILM) peeling

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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