Evaluation of Anatomic and Visual Outcomes of Initially Closed Macular Holes

This study has been completed.
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01229657
First received: October 27, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

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.


Condition
Macular Holes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Study of the Anatomic and Visual Outcomes in Patients With Initially Closed Macular Holes After Vitreoretinal Surgery

Further study details as provided by Sun Yat-sen University:

Enrollment: 79
Study Start Date: March 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with initially closed macular holes after vitreoretinal surgery and with one to seven years of follow-up

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01229657

Locations
China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Study Chair: Shaochong Zhang, MD Zhongshan Ophthalmic Center, Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Shaochong Zhang, Zhongshan Ophthalmic Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01229657     History of Changes
Other Study ID Numbers: SunYat-senU, 2008B030301306, 2007B031302007
Study First Received: October 27, 2010
Last Updated: October 27, 2010
Health Authority: China: Ethics Committee

Keywords provided by Sun Yat-sen University:
Reopening of macular hole;
Visual acuity;
Phacoemulsification cataract surgery;
Vitrectomy

Additional relevant MeSH terms:
Retinal Perforations
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 20, 2014