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Macular Hole Reopening

Incidence and Factors Related to Macular Hole Reopening

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00927628
Enrollment
831
Registered
2009-06-25
Start date
1990-10-31
Completion date
2008-12-31
Last updated
2009-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitrectomy

Keywords

vitrectomy, macular hole, ILM peeling

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.

Interventions

PROCEDUREVitrectomy

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.

Sponsors

Shinjo Ophthalmologic Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years

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.

Design outcomes

Primary

MeasureTime frame
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.

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026