Evaluation of Anatomic and Visual Outcomes of Initially Closed Macular Holes

Completed

• Conditions: Macular Holes

• Registration Number: NCT01229657
• Lead Sponsor: Sun Yat-sen University

Brief Summary

To evaluate the anatomic and visual outcomes in patients with initially closed macular holes after vitreoretinal surgery and with one to seven years of follow-up.

Detailed Description

In recent years, peeling of the internal limiting membrane (ILM) has been used as a supplementary treatment to reducing the tangential tractional forces and inducing hole closure in macular hole surgery, and thus the anatomic success rate has increased to over 90%. However, despite these high rates of surgical success, the reopening of initially closed macular holes has also been observed from the first month to several years following surgery. Because about 45% to 95% of phakic patients frequently develop a progressive nuclear sclerosis cataract after macular hole surgery and require combined or subsequent cataract extraction to improve visual acuity, cataract extraction has become a potential factor in causing macular hole reopening, although this is still under debate. The purpose of this study is to describe the long-term anatomic and visual outcomes in patients who had initial anatomic success with macular hole surgery and who had postoperative follow-up of one or more years. All patient's charts were reviewed for age, macular hole stage (using the Gass classification), macular hole duration, epiretinal membrane of macula presence, ILM peeling, preoperative and postoperative visual acuity, rate of macular hole reopening, cataract extraction, and length of follow-up after vitrectomy.

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2010-10
• Study First Submitted: 2010-10-27
• Study First Submitted QC: 2010-10-27
• Last Update Submitted: 2010-10-27
• Study First Posted: 2010-10-28
• Last Update Posted: 2010-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

• successful closure of a macular hole after initial vitreoretinal surgery
• a follow-up of at least one year

Exclusion Criteria

• post-traumatic holes,
• myopic macular holes,
• macular holes associated with a rhegmatogenous retinal detachment,
• eyes with silicone oil tamponade.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China