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Evaluation of Anatomic and Visual Outcomes of Initially Closed Macular Holes

NCT ID: NCT01229657

Last Updated: 2010-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-05-31

Brief Summary

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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

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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.

Conditions

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Macular Holes

Keywords

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Reopening of macular hole; Visual acuity; Phacoemulsification cataract surgery; Vitrectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Zhongshan Ophthalmic Center, Sun Yat-sen University

Principal Investigators

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Shaochong Zhang, MD

Role: STUDY_CHAIR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

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Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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2008B030301306

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2007B031302007

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SunYat-senU

Identifier Type: -

Identifier Source: org_study_id