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.

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Key information

Conditions

Vitrectomy Eye Diseases Retinal Diseases Retinal Perforations

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shinjo Ophthalmologic Institute

Miyazaki, 880-0035, Japan

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitrectomy

Procedure

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Shinjo Ophthalmologic Institute

Other

Registry information

Official study title

Incidence and Factors Related to Macular Hole Reopening

Important dates

Study start: 1990
Primary completion: 2008
Study completion: 2008
First posted: Jun 25, 2009
Registry last updated: Jun 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed