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SuspendedNCT02915133Updated Sep 19, 2019

The Relationship Between Structure and Visual Function in Myopia Foveoschisis

An observational study in High Myopia, sponsored by Sun Yat-sen University. Suspended at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-19.

Sponsored by Sun Yat-sen University · Observational

Why this study was suspended
study changed waiting renew
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • High Myopia

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Keywords

  • high myopia
  • myopia foveoschisis
  • macular buckling
03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's planned enrollment of 20 is below the median of 150 across 173 observational studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • MF-MB

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

    Procedure: macular buckling surgery

Interventions

  • Proceduremacular buckling surgery

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

06

What researchers measure

Primary outcomes

  1. change from baseline OCT at 6 months

    Time frame: 6 month postoperatively

  2. change from multifocal ERG at 6 months

    Time frame: 6 month postoperatively

Secondary outcomes

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

    Time frame: 6 month postoperatively

07

Study locations

1 site
  • Zhongshan Ophthalmic Center, Sun Yat-sen University
    Guangzhou, Guangdong 510060, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02915133
Lead sponsor
Sun Yat-sen University
Responsible party
Lin Lu (Director, Fundus Disease Center of Zhongshan Ophthalmic Center, Sun Yat-sen University) — Principal investigator
First posted
Sep 26, 2016
Start date
Oct 2016
Primary completion
Dec 2020 (estimated)
Completion
Sep 18, 2021 (estimated)
Last update
Sep 19, 2019
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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