Macular Hole Reopening

Vitrectomy Clinical Trial

Official title:

Incidence and Factors Related to Macular Hole Reopening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00927628
• Other study ID #: ShinjoOI
• Status: Completed
• Phase: N/A
• First received: June 24, 2009
• Last updated: June 24, 2009
• Start date: October 1990
• Est. completion date: December 2008

Study information

• Verified date: June 2009
• Source: Shinjo Ophthalmologic Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 831
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Vitrectomy

Intervention

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.

Locations

Country	Name	City	State
Japan	Shinjo Ophthalmologic Institute	Miyazaki

Sponsors (1)

Lead Sponsor	Collaborator
Shinjo Ophthalmologic Institute

Country where clinical trial is conducted

Japan, 

References & Publications (6)

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. — View Citation

Gross JG. Late reopening and spontaneous closure of previously repaired macular holes. Am J Ophthalmol. 2005 Sep;140(3):556-8. — View Citation

Kokame GT. Recurrence of macular holes. Ophthalmology. 1995 Feb;102(2):172-3. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No