Predictors of Vitrectomy Outcomes in Myopic Foveoschisis

NCT07774637 | Recruiting DMC

• 1 other identifier: R2028/71/2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective pilot study evaluates factors that predict outcomes after vitrectomy for myopic foveoschisis (MFS), a sight-threatening complication of high myopia that can lead to progressive visual loss, foveal detachment, macular holes, and retinal detachment. Although vitrectomy can relieve traction and improve retinal anatomy, the optimal timing of surgery and the factors associated with visual recovery remain uncertain, particularly in patients with relatively good pre-operative vision. The study will recruit 30 adults aged 40-90 years from Singapore National Eye Centre surgical retina clinics. Participants must have high myopia (worse than -6 dioptres and axial length \>26 mm) with MFS requiring surgery because of progressive vision loss with OCT-confirmed deterioration over six months and/or foveal detachment. Patients with other ocular diseases or conditions that could confound imaging or functional testing, poor surgical candidacy, cognitive impairment, or ungradable imaging will be excluded. Participants will undergo standard-of-care 23- or 25-gauge pars plana vitrectomy, with fovea-sparing internal limiting membrane peeling or flap, possible gas tamponade, and cataract surgery where clinically indicated. The research does not alter the usual surgical approach; its main purpose is to collect structural and functional outcome data over 12 months. Assessments will be performed at baseline and during postoperative follow-up, including best-corrected visual acuity, refracted logMAR visual acuity, microperimetry, M-chart testing for metamorphopsia, contrast sensitivity using the Manifold Contrast Vision Meter, and swept-source OCT. OCT measures will include central retinal thickness, foveal detachment, inner and outer macular schisis, lamellar holes, and epiretinal membrane. Demographic and clinical variables, including age, sex, co-morbidities, and lens status, will also be collected. The primary functional outcome is stable or improved best-corrected visual acuity. Anatomical success is defined as improvement in retinoschisis and resolution of pre-existing foveal detachment. The investigators hypothesise that improvement can occur across a range of MFS severities, and that baseline OCT features and functional measures can help predict 12-month surgical success. As a pilot study, no formal sample-size calculation is planned. Analyses will describe clinical characteristics, compare outcomes between better and poorer pre-operative visual-acuity groups, and use multivariable logistic regression to identify prognostic factors. Risks are limited to usual surgical complications and confidentiality risks; all study tests are non-invasive. Data will be securely stored, access restricted to the study team, and participants will provide informed consent. Parallel studies will be conducted with overseas collaborators.

Conditions

Myopic Traction Maculopathy

Keywords

myopic foveoschisis; pars plana vitrectomy; internal limiting membrane peel; pathological myopia; myopic traction maculopathy

Outcome Measures

Primary Outcomes (2)

• visual acuity

  change in best corrected snellen chart visual acuity

  12 months

• anatomical success

  change in retinoschisis and resolution of pre-existing foveal detachment as measured via optical coherence tomography in microns

  12 months

Study Arms (1)

Predictors of Vitrectomy Outcomes in Myopic Foveoschisis

ACTIVE COMPARATOR

pars plana vitrectomy and internal limiting membrane peel / flap in various stages of myopic foveoschisis

Procedure: pars plana vitrectomy

Interventions

pars plana vitrectomy PROCEDURE

pars plana vitrectomy with internal limiting membrane peel or flap

Predictors of Vitrectomy Outcomes in Myopic Foveoschisis

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• patients with ocular disorders, prior treatments, or other conditions that could affect structural imaging or functional measurements
• corneal opacity
• uveitis
• dense cataract
• vitreous haemorrhage
• central serous chorioretinopathy
• prior retinal laser photocoagulation or photodynamic therapy
• previous or concurrent retinal detachment
• retinal dystrophies
• macular scarring
• retinal vascular occlusion
• ocular ischaemic syndrome
• ungradable OCT/OCTA imaging.
• Patients who are cognitively impaired or prisoners are excluded.
• Patients considered poor highly myopic surgical candidates are also excluded, including those with myopic choroidal neovascularisation, macular scar, or complete macular atrophy according to the ATN classification.

Sponsors & Collaborators

• Singapore National Eye Centre: lead
• Chang Gung Memorial Hospital: collaborator

Study Sites (1)

Singapore National Eye Centre

Singapore, Singapore, 168751, Singapore

RECRUITING

Related Publications (3)

• Ikuno Y, Sayanagi K, Ohji M, Kamei M, Gomi F, Harino S, Fujikado T, Tano Y. Vitrectomy and internal limiting membrane peeling for myopic foveoschisis. Am J Ophthalmol. 2004 Apr;137(4):719-24. doi: 10.1016/j.ajo.2003.10.019.

  PMID: 15059711 BACKGROUND

• Figueroa MS, Ruiz-Moreno JM, Gonzalez del Valle F, Govetto A, de la Vega C, Plascencia RN, Contreras I, Medina JL. LONG-TERM OUTCOMES OF 23-GAUGE PARS PLANA VITRECTOMY WITH INTERNAL LIMITING MEMBRANE PEELING AND GAS TAMPONADE FOR MYOPIC TRACTION MACULOPATHY: A Prospective Study. Retina. 2015 Sep;35(9):1836-43. doi: 10.1097/IAE.0000000000000554.

  PMID: 25946689 BACKGROUND

• Gohil R, Sivaprasad S, Han LT, Mathew R, Kiousis G, Yang Y. Myopic foveoschisis: a clinical review. Eye (Lond). 2015 May;29(5):593-601. doi: 10.1038/eye.2014.311. Epub 2015 Mar 6.

  PMID: 25744445 BACKGROUND

MeSH Terms

Conditions

Myopia, Degenerative

Condition Hierarchy (Ancestors)

Myopia; Refractive Errors; Eye Diseases

Study Officials

• Andrew Tsai, MD

  Singapore National Eye Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Tsai, MD

CONTACT

+65 6227 7255; andrew.tsai.s.h@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 19, 2026
• Study Start: June 10, 2024
• Primary Completion (Estimated): June 10, 2028
• Study Completion (Estimated): June 10, 2029
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)