Evaluation of Anatomic and Visual Outcomes of Initially Closed Macular Holes

Macular Holes Clinical Trial

Official title:

Study of the Anatomic and Visual Outcomes in Patients With Initially Closed Macular Holes After Vitreoretinal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01229657
• Other study ID #: SunYat-senU
• Secondary ID: 2008B03030130620
• Status: Completed
• Phase: N/A
• First received: October 27, 2010
• Last updated: October 27, 2010
• Start date: March 2010
• Est. completion date: May 2010

Study information

• Verified date: October 2010
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Macular Holes
• Retinal Perforations

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China,