Back to resultsEfficacy and Safety of Posterior Scleral Reinforcement on Controlling Myopia in Adults With High Myopia
Primary Purpose
High Myopia, Posterior Scleral Reinforcement, Adults
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Posterior scleral reinforcement
Sponsored by
About this trial
This is an interventional treatment trial for High Myopia
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Surgical group
Control group
Arm Description
In this arm, the adults with high myopia will be given posterior scleral reinforcement.
In this arm, the adults with high myopia will not be given any surgical treatment.
Outcomes
Primary Outcome Measures
Cycloplegic autorefraction
Level of myopia and myopia progression as assessed by autorefraction
Axial length
Longth of the eyeball as assessed by IOL Master or Lenstar
Secondary Outcome Measures
Number of participants with treatment-related adverse events
Bleeding, inflammation or retinal detachment as assessed by B scan, slitlamp, etc.
Visual acuity
An index for visual function measured by visual acuity chart
Full Information
NCT ID
NCT03381079
First Posted
December 12, 2017
Last Updated
December 20, 2017
Sponsor
Beijing Tongren Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03381079
Brief Title
Efficacy and Safety of Posterior Scleral Reinforcement on Controlling Myopia in Adults With High Myopia
Official Title
Posterior Scleral Reinforcement for Adults With High Myopia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Anticipated)
Primary Completion Date
October 1, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tongren Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Myopia, Posterior Scleral Reinforcement, Adults, Axial Elongation, Myopia Progression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surgical group
Arm Type
Experimental
Arm Description
In this arm, the adults with high myopia will be given posterior scleral reinforcement.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
In this arm, the adults with high myopia will not be given any surgical treatment.
Intervention Type
Procedure
Intervention Name(s)
Posterior scleral reinforcement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cycloplegic autorefraction
Description
Level of myopia and myopia progression as assessed by autorefraction
Time Frame
2 years
Title
Axial length
Description
Longth of the eyeball as assessed by IOL Master or Lenstar
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events
Description
Bleeding, inflammation or retinal detachment as assessed by B scan, slitlamp, etc.
Time Frame
2 years
Title
Visual acuity
Description
An index for visual function measured by visual acuity chart
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shi-Ming Li, PhD
Phone
+86-10-58269920
Email
lishiming81@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ningli Wang, PhD
Organizational Affiliation
Beijing Tongren Eye Center, Beijing Tongren Hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy and Safety of Posterior Scleral Reinforcement on Controlling Myopia in Adults With High Myopia
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