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
• Status: Suspended
• 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
• 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.

Related Conditions & MeSH terms

• High Myopia
• Myopia

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