Pars Plana Vitrectomy Alone in the Treatment of Macular Schisis in High Myopic Eyes

July 2, 2018 updated by: Aier School of Ophthalmology, Central South University

Application of Pars Plana Vitrectomy in the Treatment of Macular Schisis in High Myopic Eyes

High myopic schisis (HMF) has the clinical feature of separation between retinal layers. It is sometimes accompanied with foveal retinal detachment, macular lamellar hole, epiretinal membrane and vitreous retraction. HMF may develop to macular hole, macular detachment and will damage the visual function. Pars plana vitrectomy (PPV) is a commonly used surgery in the treatment of HMF. PPV together with internal limiting membrane (ILM) peeling and long-term gas tamponade was reported to be safe and effective. But nowadays there was no available long-term gas in our country. Also, whether ILM peeling is necessary remains controversial, Indole cyanine green (ICG)was proved to have potential toxicity to the retina and the ILM peeling has the risk of causing secondary macular hole. We propose to make a prospective nonrandomized controlled study to evaluate the safety and efficiency of using PPV alone in the treatment of HMF.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Wensheng Li, Doctor
  • Phone Number: +8618650424985 +8618650424985
  • Email: drlws@qq.com

Study Locations

  • China
      • Shanghai, China, 200000
        • Recruiting
        • Shanghai Aier Eye Hospital
        • Contact:
        • Contact:
          • Wensheng Li, Doctor
          • Phone Number: +8618650424985 +8618650424985
          • Email: drlws@qq.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study population will be selected from the in-patients in Shanghai Aier Eye Hospital.

Description

Inclusion Criteria:

  1. Patients diagnosed as high myopic macular retinoschisis, with axial length more than 26.5mm.
  2. Morphologic manifestation in OCT shows split between retinal layers in macular area.
  3. Patients without severe systemic disease and can tolerate surgery.

Exclusion Criteria:

  1. Patients also have other ocular disease, including glaucoma, keratitis,uveitis, retinal detachment,etc.
  2. Patients with nystagmus or have difficult to open the eye.
  3. Patients with severe systemic disease and cannot tolerate surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with HMF
Patients who are diagnosed as high myopic macular schisis and agree to receive pars plana vitrectomy as the treatment are planned to allocated in this group
Procedure: Pars plana vitrectomy
pars plana vitrectomy without ICG staining and ILM peeling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The morphologic change of macular area
Time Frame: OCT will be done one day before surgery and one week, one month, three months and six months after surgery
The thickness of the macular fovea in optical coherence tomography (OCT)
OCT will be done one day before surgery and one week, one month, three months and six months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The best corrected visual acuity (BCVA) change
Time Frame: One day before surgery and one week, one month, three months and six months after surgery
The BCVA of all involved patients
One day before surgery and one week, one month, three months and six months after surgery
The best corrected near visual acuity (BCNVA) change
Time Frame: One day before surgery and one week, one month, three months and six months after surgery
The BCNVA of all involved patients
One day before surgery and one week, one month, three months and six months after surgery
The visual function change
Time Frame: One day before surgery and one week, one month, three months and six months after surgery
The contrast sensitivity of all involved patients
One day before surgery and one week, one month, three months and six months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aier School of Ophthalmology, Central South University

Investigators

  • Study Director: Wensheng Li, Doctor, Shanghai Aier Eye Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

May 31, 2019

Study Registration Dates

First Submitted

June 15, 2018

First Submitted That Met QC Criteria

July 2, 2018

First Posted (Actual)

July 13, 2018

Study Record Updates

Last Update Posted (Actual)

July 13, 2018

Last Update Submitted That Met QC Criteria

July 2, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHIRB2018014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

all individual participant data (IPD) that underlie results

IPD Sharing Time Frame

After this study is finished the data will become available for 1year.

IPD Sharing Access Criteria

The analytical data will be accessed in published articles.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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