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Macular Hole Reopening

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00927628
First Posted: June 25, 2009
Last Update Posted: June 25, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shinjo Ophthalmologic Institute
  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. ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes 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.
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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