Macular Hole Reopening

This study has been completed.
Sponsor:
Information provided by:
Shinjo Ophthalmologic Institute
ClinicalTrials.gov Identifier:
NCT00927628
First received: June 24, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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 Intervention
Vitrectomy
Procedure: Vitrectomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Incidence and Factors Related to Macular Hole Reopening

Further study details as provided by Shinjo Ophthalmologic Institute:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 831
Study Start Date: October 1990
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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.

Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00927628

Locations
Japan
Shinjo Ophthalmologic Institute
Miyazaki, Japan, 880-0035
Sponsors and Collaborators
Shinjo Ophthalmologic Institute
Investigators
Principal Investigator: Kazuyuki Kumagai, MD Shinjo Ophthalmologic Institute
  More Information

Publications:
Responsible Party: Dr. Kazuyuki Kumagai, Shinjo Ophthalmologic Institute
ClinicalTrials.gov Identifier: NCT00927628     History of Changes
Other Study ID Numbers: ShinjoOI
Study First Received: June 24, 2009
Last Updated: June 24, 2009
Health Authority: Japan: Institutional Review Board

Keywords provided by Shinjo Ophthalmologic Institute:
vitrectomy
macular hole
ILM peeling

Additional relevant MeSH terms:
Retinal Perforations
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 31, 2014