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NCT02915133 Clinical Trial

The Relationship Between Structure and Visual Function in Myopia Foveoschisis

High Myopia Clinical Trial

Official title:
Correlation of Structural and Visual Function Changes in Myopia Foveoschisis Patients Undergoing Macular Buckle Surgery

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT02915133
Other study ID # 2016HM-MF
Secondary ID
Status Suspended
Phase
First received
Last updated
Start date October 2016
Est. completion date September 18, 2021

Study information
Verified date September 2019
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Suspended
Enrollment 20
Est. completion date September 18, 2021
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• macular buckling surgery
Participants with high myopia foveoschisis are scheduled to macular buckling (MB) surgery.

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, 

Outcome
Type Measure Description Time frame Safety issue
Primary change from baseline OCT at 6 months 6 month postoperatively
Primary change from multifocal ERG at 6 months 6 month postoperatively
Secondary change from Best-corrected visual acuity (BCVA) at 6 months 6 month postoperatively
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