The Relationship Between Structure and Visual Function in Myopia Foveoschisis

• Sponsor: Sun Yat-sen University (Other)
• Overall Status: Suspended
• CT.gov ID: NCT02915133
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Duration (Months): 59.6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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	Phase
High Myopia	Procedure: macular buckling surgery

Study Design

• Study Type: Observational
• Anticipated 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: Oct 1, 2016
• Anticipated Primary Completion Date: Dec 1, 2020
• Anticipated Study Completion Date: Sep 18, 2021

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. change from baseline OCT at 6 months [6 month postoperatively]

2. change from multifocal ERG at 6 months [6 month postoperatively]

Secondary Outcome Measures

1. change from Best-corrected visual acuity (BCVA) at 6 months [6 month postoperatively]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong	China	510060

Sponsors and Collaborators

• Sun Yat-sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lin Lu, Director, Fundus Disease Center of Zhongshan Ophthalmic Center, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT02915133
• Other Study ID Numbers: 2016HM-MF
• First Posted: Sep 26, 2016
• Last Update Posted: Sep 19, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Lin Lu, Director, Fundus Disease Center of Zhongshan Ophthalmic Center, Sun Yat-sen University: high myopia; myopia foveoschisis; macular buckling
• Additional relevant MeSH terms: Myopia

Study Results

No Results Posted as of Sep 19, 2019