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

Sponsor
Beijing Tongren Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03381079
Collaborator
(none)
120
Enrollment
2
Arms
33
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Posterior scleral reinforcement
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Posterior Scleral Reinforcement for Adults With High Myopia
Anticipated Study Start Date :
Apr 1, 2018
Anticipated Primary Completion Date :
Oct 1, 2020
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Cycloplegic autorefraction [2 years]

    Level of myopia and myopia progression as assessed by autorefraction

  2. Axial length [2 years]

    Longth of the eyeball as assessed by IOL Master or Lenstar

Secondary Outcome Measures

  1. Number of participants with treatment-related adverse events [2 years]

    Bleeding, inflammation or retinal detachment as assessed by B scan, slitlamp, etc.

  2. Visual acuity [2 years]

    An index for visual function measured by visual acuity chart

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Beijing Tongren Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shi-Ming Li, Vice director of Ophthalmology clinical research center, Beijing Tongren Hospital
ClinicalTrials.gov Identifier:
NCT03381079
Other Study ID Numbers:
  • TRECKY2017-049
First Posted:
Dec 21, 2017
Last Update Posted:
Dec 22, 2017
Last Verified:
Dec 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Myopia

Study Results

No Results Posted as of Dec 22, 2017