Macular Hole Reopening

NCT ID: NCT00927628

Last Updated: 2009-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

831 participants

Study Classification

OBSERVATIONAL

Study Start Date

1990-10-31

Study Completion Date

2008-12-31

Brief Summary

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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

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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.

Conditions

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Vitrectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Vitrectomy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shinjo Ophthalmologic Institute

OTHER

Sponsor Role lead

Responsible Party

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Shinjo Ophthalmologic Institute

Principal Investigators

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Kazuyuki Kumagai, MD

Role: PRINCIPAL_INVESTIGATOR

Shinjo Ophthalmologic Institute

Locations

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Shinjo Ophthalmologic Institute

Miyazaki, Miyazaki, Japan

Site Status

Countries

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Japan

References

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Duker JS, Wendel R, Patel AC, Puliafito CA. Late re-opening of macular holes after initially successful treatment with vitreous surgery. Ophthalmology. 1994 Aug;101(8):1373-8. doi: 10.1016/s0161-6420(13)31174-9.

Reference Type BACKGROUND
PMID: 8058282 (View on PubMed)

Kokame GT. Recurrence of macular holes. Ophthalmology. 1995 Feb;102(2):172-3. doi: 10.1016/s0161-6420(95)31042-1. No abstract available.

Reference Type BACKGROUND
PMID: 7862400 (View on PubMed)

Kumagai K, Furukawa M, Ogino N, Uemura A, Demizu S, Larson E. Vitreous surgery with and without internal limiting membrane peeling for macular hole repair. Retina. 2004 Oct;24(5):721-7. doi: 10.1097/00006982-200410000-00006.

Reference Type BACKGROUND
PMID: 15492625 (View on PubMed)

Gross JG. Late reopening and spontaneous closure of previously repaired macular holes. Am J Ophthalmol. 2005 Sep;140(3):556-8. doi: 10.1016/j.ajo.2005.03.044.

Reference Type BACKGROUND
PMID: 16139019 (View on PubMed)

Kumagai K, Furukawa M, Ogino N, Larson E, Uemura A. Long-term outcomes of macular hole surgery with triamcinolone acetonide-assisted internal limiting membrane peeling. Retina. 2007 Nov-Dec;27(9):1249-54. doi: 10.1097/IAE.0b013e3180ed45cc.

Reference Type BACKGROUND
PMID: 18046233 (View on PubMed)

Kumagai K, Ogino N, Furukawa M, Larson E, Uemura A. Surgical outcomes for patients who develop macular holes after pars plana vitrectomy. Am J Ophthalmol. 2008 Jun;145(6):1077-80. doi: 10.1016/j.ajo.2008.01.030. Epub 2008 Apr 18.

Reference Type BACKGROUND
PMID: 18378210 (View on PubMed)

Other Identifiers

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ShinjoOI

Identifier Type: -

Identifier Source: org_study_id

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