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

Phase 2

• Conditions: Posterior Scleral Reinforcement; High Myopia; Myopia Progression; Axial Elongation; Adults
• Interventions: Procedure: Posterior scleral reinforcement

• Registration Number: NCT03381079
• Lead Sponsor: Beijing Tongren Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-12
• Study First Submitted: 2017-12-12
• Study First Submitted QC: 2017-12-17
• Last Update Submitted: 2017-12-20
• Study First Posted: 2017-12-21
• Last Update Posted: 2017-12-22
• Study Start: 2018-04-01
• Primary Completion: 2020-10-01
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical group	Posterior scleral reinforcement	In this arm, the adults with high myopia will be given posterior scleral reinforcement.

Primary Outcome Measures

Name	Time	Method
Cycloplegic autorefraction	2 years	Level of myopia and myopia progression as assessed by autorefraction
Axial length	2 years	Longth of the eyeball as assessed by IOL Master or Lenstar

Secondary Outcome Measures

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