Efficacy and Safety of Posterior Scleral Reinforcement on Controlling Myopia in Adults With High Myopia
Posterior Scleral Reinforcement for Adults With High Myopia
1 other identifier
interventional
120
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2018
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2017
CompletedFirst Posted
Study publicly available on registry
December 21, 2017
CompletedStudy Start
First participant enrolled
April 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedDecember 22, 2017
December 1, 2017
2.5 years
December 12, 2017
December 20, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Cycloplegic autorefraction
Level of myopia and myopia progression as assessed by autorefraction
2 years
Axial length
Longth of the eyeball as assessed by IOL Master or Lenstar
2 years
Secondary Outcomes (2)
Number of participants with treatment-related adverse events
2 years
Visual acuity
2 years
Study Arms (2)
Surgical group
EXPERIMENTALIn this arm, the adults with high myopia will be given posterior scleral reinforcement.
Control group
NO INTERVENTIONIn this arm, the adults with high myopia will not be given any surgical treatment.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- STUDY CHAIR
Ningli Wang, PhD
Beijing Tongren Eye Center, Beijing Tongren Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice director of Ophthalmology clinical research center
Study Record Dates
First Submitted
December 12, 2017
First Posted
December 21, 2017
Study Start
April 1, 2018
Primary Completion
October 1, 2020
Study Completion
December 31, 2020
Last Updated
December 22, 2017
Record last verified: 2017-12