The Relationship Between Structure and Visual Function in Myopia Foveoschisis

September 17, 2019 updated by: Lin Lu, Sun Yat-sen University

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Zhongshan Ophthalmic Center, Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change from baseline OCT at 6 months
Time Frame: 6 month postoperatively
6 month postoperatively
change from multifocal ERG at 6 months
Time Frame: 6 month postoperatively
6 month postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
change from Best-corrected visual acuity (BCVA) at 6 months
Time Frame: 6 month postoperatively
6 month postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

September 18, 2021

Study Registration Dates

First Submitted

September 4, 2016

First Submitted That Met QC Criteria

September 23, 2016

First Posted (Estimate)

September 26, 2016

Study Record Updates

Last Update Posted (Actual)

September 19, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016HM-MF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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