The Relationship Between Structure and Visual Function in Myopia Foveoschisis

NCT02915133 | Suspended

• 1 other identifier: 2016HM-MF
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

High Myopia

Keywords

high myopia; myopia foveoschisis; macular buckling

Outcome Measures

Primary Outcomes (2)

• change from baseline OCT at 6 months

  6 month postoperatively

• change from multifocal ERG at 6 months

  6 month postoperatively

Secondary Outcomes (1)

• change from Best-corrected visual acuity (BCVA) at 6 months

  6 month postoperatively

Study Arms (1)

MF-MB

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

Procedure: macular buckling surgery

Interventions

macular buckling surgery PROCEDURE

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

MF-MB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• axial length ≥ 26.5 mm or refractive error (spherical equivalent) ≥ 8.0 diopter;
• macular foveoschisis that requires surgical intervention.

You may not qualify if:

• ocular trauma or surgery history;
• glaucoma, diabetic retinopathy;
• intraocular active hemorrhage or inflammation;
• unable to coordinate the OCT, mfERG, or other ophthalmological examinations.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Fundus Disease Center of Zhongshan Ophthalmic Center

Study Record Dates

• First Submitted: September 4, 2016
• First Posted: September 26, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: September 18, 2021
• Last Updated: September 19, 2019

Record last verified: 2019-09

Locations

CN (1)