NCT05628909

Brief Summary

The purpose of this study is to explore the efficiency and safety of the surgical procedure of pars plana vitrectomy with silicone oil tamponade and without internal limiting membrane peeling for myopic foveoschisis eyes with high risk of macular hole formation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
159

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 29, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 29, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 29, 2022

Status Verified

November 1, 2022

Enrollment Period

2.2 years

First QC Date

November 8, 2022

Last Update Submit

November 26, 2022

Conditions

Hypermyopic Foveoschisis

Outcome Measures

Primary Outcomes (1)

  • Complete resolved rate of foveoschisis observed on OCT image.

    The compete resolved of foveoschisis was evaluated using OCT image.

    18 months

Secondary Outcomes (2)

  • Best corrected visual acuity (BCVA) change compared with baseline BCVA.

    18 months

  • The posoperative macular hole formation rate.

    18 months

Study Arms (3)

Silicone oil group

EXPERIMENTAL

Patients randomized into this group were received pars plana vitrectomy surgery with silicone oil tamponade and without internal limiting membrane peeling. And silicone oil tamponade was removed at least 12 months after the primary surgery with completely resolved of foveoschisis.

Procedure: PPV with SO tamponade

Gas group 1

ACTIVE COMPARATOR

Patients randomized into this group were received pars plana vitrectomy surgery with fovea-sparing internal limiting membrane peeling and gas tamponade.

Procedure: PPV with fovea-sparing ILMP and gas tamponade

Gas group 2

ACTIVE COMPARATOR

Patients randomized into this group were received pars plana vitrectomy surgery with gas tamponade and without internal limiting membrane peeling.

Procedure: PPV with gas tamponade

Interventions

PPV with SO tamponadePROCEDURE

Patients randomized into silicone oil group were received pars plana vitrectomy surgery with silicone oil tamponade and without internal limiting membrane peeling. And silicone oil tamponade was removed at least 12 months after the primary surgery with completely resolved of foveoschisis.

Silicone oil group
PPV with fovea-sparing ILMP and gas tamponadePROCEDURE

Patients randomized into gas group 1 were received pars plana vitrectomy surgery with fovea-sparing internal limiting membrane peeling and gas tamponade.

Gas group 1
PPV with gas tamponadePROCEDURE

Patients randomized into gas group 2 were received pars plana vitrectomy surgery without internal limiting membrane peeling and gas tamponade.

Gas group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with spherical ≥ -8 diopters or axial length ≥ 26.5mm.
  • The foveoshisis combined with foveal detachment was showed on the OCT image. The foveal detachment height≥ 250 um ,and the thickness of sensory retina of foveal detachment was ≤100 um;
  • patients signed the ICF.
  • patients with BCVA ≤0.5,and with visual disturbance symptoms.

You may not qualify if:

  • patients with macular hole
  • accompanied or secondary of other fundus disease
  • received vitrectomy due to other diseases
  • glaucoma cannot be controled by medication
  • patients with other retinal or choroidal disease that may affect VA
  • poor patients compliance
  • poor condition that cannot undertake the surgery
  • optical opacities which make it difficult to exam fundus or measure on OCT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Interventions

Predictive Value of Tests

Intervention Hierarchy (Ancestors)

Sensitivity and SpecificityEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Mingwei Zhao, M.D.

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

  • Yuou Yao, M.D.

    Peking University People's Hospital

    STUDY DIRECTOR

Central Study Contacts

Mingwei Zhao, M.D.

CONTACT

13801057408dr_mingweizhao@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Opthalmology department

Study Record Dates

First Submitted

November 8, 2022

First Posted

November 29, 2022

Study Start

October 29, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

November 29, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)