Posterior Scleral Reinforcement for Adults With High Myopia
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 120
- Primary Endpoint
- Cycloplegic autorefraction
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Surgical group
In this arm, the adults with high myopia will be given posterior scleral reinforcement.
Intervention: Posterior scleral reinforcement (Procedure)
Control group
In this arm, the adults with high myopia will not be given any surgical treatment.
Outcomes
Primary Outcomes
Cycloplegic autorefraction
Time Frame: 2 years
Level of myopia and myopia progression as assessed by autorefraction
Axial length
Time Frame: 2 years
Longth of the eyeball as assessed by IOL Master or Lenstar
Secondary Outcomes
- Visual acuity(2 years)
- Number of participants with treatment-related adverse events(2 years)
Investigators
Shi-Ming Li
Vice director of Ophthalmology clinical research center
Beijing Tongren Hospital