Macular Hole Reopening

June 24, 2009 updated by: Shinjo Ophthalmologic Institute

Incidence and Factors Related to Macular Hole Reopening

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

831

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Miyazaki, Japan, 880-0035
        • Shinjo Ophthalmologic Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Eight hundred seventy-seven eyes of 831 patients with a mean age of 64.9 ± 8.0 years were studied.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A complete clinical examination including BCVA, slit-lamp biomicroscopy with a contact lens, indirect ophthalmoscopy, and fundus photography were performed post surgery.
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shinjo Ophthalmologic Institute

Investigators

  • Principal Investigator: Kazuyuki Kumagai, MD, Shinjo Ophthalmologic Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1990

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

June 24, 2009

First Submitted That Met QC Criteria

June 24, 2009

First Posted (Estimate)

June 25, 2009

Study Record Updates

Last Update Posted (Estimate)

June 25, 2009

Last Update Submitted That Met QC Criteria

June 24, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShinjoOI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vitrectomy

Clinical Trials on Vitrectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe