Clinical trial NCT00927628: Macular Hole Reopening
Official title: Incidence and Factors Related to Macular Hole Reopening
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitrectomy
Keywords: vitrectomy
macular hole
ILM peeling
Lead sponsor: Shinjo Ophthalmologic Institute
Sponsor class: OTHER
First posted: 2009-06-25
Enrollment: 831
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief 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.

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 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.

Primary outcomes:
measure: A complete clinical examination including BCVA, slit-lamp biomicroscopy with a contact lens, indirect ophthalmoscopy, and fundus photography were performed post surgery.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Miyazaki
country: Japan
facility: Shinjo Ophthalmologic Institute
Study officials:
affiliation: Shinjo Ophthalmologic Institute
name: Kazuyuki Kumagai, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Kokame GT. Recurrence of macular holes. Ophthalmology. 1995 Feb;102(2):172-3. doi: 10.1016/s0161-6420(95)31042-1. No abstract available.
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. doi: 10.1097/00006982-200410000-00006.
citation: 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.
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. doi: 10.1097/IAE.0b013e3180ed45cc.
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.