Macular Hole Reopening

Sponsor
Shinjo Ophthalmologic Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00927628
Collaborator
(none)
831
1
218
3.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Vitrectomy

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 Design

Study Type:
Observational
Actual Enrollment :
831 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Incidence and Factors Related to Macular Hole Reopening
Study Start Date :
Oct 1, 1990
Actual Primary Completion Date :
Dec 1, 2008
Actual Study Completion Date :
Dec 1, 2008

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 80 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shinjo Ophthalmologic Institute Miyazaki Japan 880-0035

Sponsors and Collaborators

  • Shinjo Ophthalmologic Institute

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00927628
Other Study ID Numbers:
  • ShinjoOI
First Posted:
Jun 25, 2009
Last Update Posted:
Jun 25, 2009
Last Verified:
Jun 1, 2009
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 25, 2009