Efficacy and Safety of Posterior Scleral Reinforcement on Controlling Myopia in Adults With High Myopia

December 20, 2017 updated by: Shi-Ming Li, Beijing Tongren Hospital

Posterior Scleral Reinforcement for Adults With High Myopia

This study will evaluate the efficacy and safety of posterior scleral reinforcement on controlling myopia progression, including change in refraction, axial elongation as well as sight-threatening complications, in adults with high myopia. Half the adults will receive posterior scleral reinforcement, while the other half will receive no surgerical treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

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

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Cycloplegic spherical equivalent less than -6.0 D
  • Myopia progression greater than 1.0 D per year
  • Normal IOP, no strabismus or any other ocular pathological changes
  • no any other ocular or systematic diseases that may affect refractive development

Exclusion Criteria:

  • Currently or history using other interventions to control myopia progression (acupuncture, drugs, contact lens, ear needles and so on)
  • Unable to cooperate with the ocular examination,questionnaire survey,or orthokeratology wearing

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surgical group
In this arm, the adults with high myopia will be given posterior scleral reinforcement.
Procedure: Posterior scleral reinforcement
Posterior scleral reinforcement (pPSR) is a procedure applied with autologous or biological material or synthetic materials reinforcing pole of the sclera after eyeball, in order to prevent or alleviate myopic development.
No Intervention: Control group
In this arm, the adults with high myopia will not be given any surgical treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cycloplegic autorefraction
Time Frame: 2 years
Level of myopia and myopia progression as assessed by autorefraction
2 years
Axial length
Time Frame: 2 years
Longth of the eyeball as assessed by IOL Master or Lenstar
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events
Time Frame: 2 years
Bleeding, inflammation or retinal detachment as assessed by B scan, slitlamp, etc.
2 years
Visual acuity
Time Frame: 2 years
An index for visual function measured by visual acuity chart
2 years

Collaborators and Investigators

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

Sponsor

Beijing Tongren Hospital

Investigators

  • Study Chair: Ningli Wang, PhD, Beijing Tongren Eye Center, Beijing Tongren Hospital

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 (Anticipated)

April 1, 2018

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

December 12, 2017

First Submitted That Met QC Criteria

December 17, 2017

First Posted (Actual)

December 21, 2017

Study Record Updates

Last Update Posted (Actual)

December 22, 2017

Last Update Submitted That Met QC Criteria

December 20, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRECKY2017-049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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