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The Relationship Between Structure and Visual Function in Myopia Foveoschisis

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

Status
Suspended
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02915133
Enrollment
20
Registered
2016-09-26
Start date
2016-10-31
Completion date
2021-09-18
Last updated
2019-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Myopia

Keywords

high myopia, myopia foveoschisis, macular buckling

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.

Interventions

PROCEDUREmacular buckling surgery

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

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
change from baseline OCT at 6 months6 month postoperatively
change from multifocal ERG at 6 months6 month postoperatively

Secondary

MeasureTime frame
change from Best-corrected visual acuity (BCVA) at 6 months6 month postoperatively

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026