Macular Hole Reopening
Completed
- Conditions
- Vitrectomy
- Registration Number
- NCT00927628
- Lead Sponsor
- Shinjo Ophthalmologic Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 831
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Shinjo Ophthalmologic Institute
🇯🇵Miyazaki, Japan
Shinjo Ophthalmologic Institute🇯🇵Miyazaki, Japan