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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
June 24, 2009
June 25, 2009
June 25, 2009
October 1990
December 2008   (Final data collection date for primary outcome measure)
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. ]
Same as current
No Changes Posted
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Macular Hole Reopening
Incidence and Factors Related to 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.
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.
Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample
Eight hundred seventy-seven eyes of 831 patients with a mean age of 64.9 ± 8.0 years were studied.
Vitrectomy
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.
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.
Intervention: Procedure: Vitrectomy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
831
December 2008
December 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
40 Years to 80 Years   (Adult, Senior)
Not Provided
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00927628
ShinjoOI
Yes
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Dr. Kazuyuki Kumagai, Shinjo Ophthalmologic Institute
Shinjo Ophthalmologic Institute
Not Provided
Principal Investigator: Kazuyuki Kumagai, MD Shinjo Ophthalmologic Institute
Shinjo Ophthalmologic Institute
June 2009