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Trial record 30 of 34 for:    myopic macular degeneration

The Relationship Between Structure and Visual Function in Myopia Foveoschisis

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ClinicalTrials.gov Identifier: NCT02915133
Recruitment Status : Unknown
Verified October 2016 by Lin Lu, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : September 26, 2016
Last Update Posted : October 7, 2016
Sponsor:
Information provided by (Responsible Party):
Lin Lu, Sun Yat-sen University

Brief Summary:
Macular foveoschisis (MF) is a common complication of pathological myopia, which is characterized by choroid-retinal degeneration and vision impairment. Although pars plana vitrectomy (PPV) is the primary method for MF treatment, there is still a large proportion of recurrent MF due to the extremely long global axial length and posterior staphyloma. Macular buckling (MB) surgery aims at counteracting the traction exerted by the posterior staphyloma, and has been proven an effective method for treating MF. Optical Coherence Tomography (OCT) is widely used for the structural analysis of MF. Multifocol electroretinogram (mfERG) is an objective examination for visual evaluation. To our knowledge, there is a lack of data on the comprehensive visual function evaluations of MF patients associated with OCT findings. Our clinical trial aims to provide the structural and functional relationship in MF patients undergoing MB surgery, and find out potential factors to determine the visual prognosis.

Condition or disease Intervention/treatment
High Myopia Procedure: macular buckling surgery

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Correlation of Structural and Visual Function Changes in Myopia Foveoschisis Patients Undergoing Macular Buckle Surgery
Study Start Date : October 2016
Estimated Primary Completion Date : December 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
MF-MB
Consecutive participants with high myopic foveoschisis are scheduled to macular buckling (MB) surgery.
Procedure: macular buckling surgery
Participants with high myopia foveoschisis are scheduled to macular buckling (MB) surgery.




Primary Outcome Measures :
  1. change from baseline OCT at 6 months [ Time Frame: 6 month postoperatively ]
  2. change from multifocal ERG at 6 months [ Time Frame: 6 month postoperatively ]

Secondary Outcome Measures :
  1. change from Best-corrected visual acuity (BCVA) at 6 months [ Time Frame: 6 month postoperatively ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive participants with high myopia associated macular foveoschsis, who scheduled for surgery at Zhongshan Ophthalmic Center, Sun Yat-sen University.
Criteria

Inclusion Criteria:

  1. axial length ≥ 26.5 mm or refractive error (spherical equivalent) ≥ 8.0 diopter;
  2. macular foveoschisis that requires surgical intervention.

Exclusion Criteria:

  1. ocular trauma or surgery history;
  2. glaucoma, diabetic retinopathy;
  3. intraocular active hemorrhage or inflammation;
  4. unable to coordinate the OCT, mfERG, or other ophthalmological examinations.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02915133


Contacts
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Contact: Lu Lin, PhD lulin888@126.com

Locations
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China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Lu Lin         
Sponsors and Collaborators
Sun Yat-sen University

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Responsible Party: Lin Lu, Director, Fundus Disease Center of Zhongshan Ophthalmic Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02915133     History of Changes
Other Study ID Numbers: 2016HM-MF
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: October 7, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Lin Lu, Sun Yat-sen University:
high myopia
myopia foveoschisis
macular buckling

Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases