The Relationship Between Structure and Visual Function in Myopia Foveoschisis

NCT ID: NCT02915133

Last Updated: 2019-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2021-09-18

Brief Summary

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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.

Detailed Description

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Conditions

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High Myopia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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MF-MB

Consecutive participants with high myopic foveoschisis are scheduled to macular buckling (MB) surgery.

macular buckling surgery

Intervention Type PROCEDURE

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

Interventions

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macular buckling surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Lin Lu

Director, Fundus Disease Center of Zhongshan Ophthalmic Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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2016HM-MF

Identifier Type: -

Identifier Source: org_study_id

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