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Evaluation of Anatomic and Visual Outcomes of Initially Closed Macular Holes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01229657
First Posted: October 28, 2010
Last Update Posted: October 28, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sun Yat-sen University
October 27, 2010
October 28, 2010
October 28, 2010
March 2010
May 2010   (Final data collection date for primary outcome measure)
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No Changes Posted
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Evaluation of Anatomic and Visual Outcomes of Initially Closed Macular Holes
Study of the Anatomic and Visual Outcomes in Patients With Initially Closed Macular Holes After Vitreoretinal Surgery
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Probability Sample
Patients with initially closed macular holes after vitreoretinal surgery and with one to seven years of follow-up
Macular Holes
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
79
May 2010
May 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01229657
SunYat-senU
2008B030301306 ( Other Grant/Funding Number: Science and Technology Projects of Guangdong Province )
2007B031302007 ( Other Grant/Funding Number: Science and Technology Projects of Guangdong Province )
Yes
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Shaochong Zhang, Zhongshan Ophthalmic Center, Sun Yat-sen University
Sun Yat-sen University
Not Provided
Study Chair: Shaochong Zhang, MD Zhongshan Ophthalmic Center, Sun Yat-sen University
Sun Yat-sen University
October 2010