Macular Hole Reopening

Completed

• Conditions: Vitrectomy
• Interventions: Procedure: Vitrectomy

• Registration Number: NCT00927628
• Lead Sponsor: Shinjo Ophthalmologic Institute

Brief Summary

The purpose of this investigation was to determine the incidence and the factors that cause a reopening of a macular hole (MH) after a surgical closure.

Detailed Description

A reopening of a macular hole (MH) is a well-known complication of successfully closed MHs. Recently, internal limiting membrane (ILM) peeling has become widely used as an adjunctive procedure during MH surgery. The incidence of a reopening of a MH is 0 to 8.6% in eyes in which the ILM was peeled off, and 2 to 16% in which the ILM was not peeled off. Part of the variation in the percentages of reopening was the length of the follow-up period; eyes with longer follow-up periods have higher incidences of reopening.

Study Timeline

• Study Start: 1990-10
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-06
• Study First Submitted: 2009-06-24
• Study First Submitted QC: 2009-06-24
• Last Update Submitted: 2009-06-24
• Study First Posted: 2009-06-25
• Last Update Posted: 2009-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 831

Inclusion Criteria

• patients who underwent vitrectomy with or without internal limiting membrane (ILM) peeling for an idiopathic full-thickness macular hole

Exclusion Criteria

• eyes with previous vitreous surgery, cystoid macular edema from any cause, and traumatically-induced MH were excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vitrectomy	Vitrectomy	Patients underwent vitrectomy with or without internal limiting membrane (ILM) peeling for an idiopathic full-thickness macular hole. Simultaneous phacoemulsification with intraocular lens implantation was performed on all phakic patients who were \>40-years-of-age.

Primary Outcome Measures

Name	Time	Method
A complete clinical examination including BCVA, slit-lamp biomicroscopy with a contact lens, indirect ophthalmoscopy, and fundus photography were performed post surgery.	Patients were examined preoperatively and postoperatively on day one, and at two weeks, and one, three, and six months. Thereafter, they were examined every three to six months.

Trial Locations

Locations (1)

Shinjo Ophthalmologic Institute; 🇯🇵 Miyazaki, Japan