Vitrectomy Clinical Trial
Official title:
Incidence and Factors Related to Macular Hole Reopening
Verified date | June 2009 |
Source | Shinjo Ophthalmologic Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 831 |
Est. completion date | December 2008 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | |
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. |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Japan | Shinjo Ophthalmologic Institute | Miyazaki |
Lead Sponsor | Collaborator |
---|---|
Shinjo Ophthalmologic Institute |
Japan,
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
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 |
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