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

Posterior Scleral Reinforcement for Adults With High Myopia

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03381079

Enrollment

120

Registered

2017-12-21

Start date

2018-04-01

Completion date

2020-12-31

Last updated

2017-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adults, Axial Elongation, High Myopia, Myopia Progression, Posterior Scleral Reinforcement

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.

Interventions

PROCEDUREPosterior 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Contacts

Primary ContactShi-Ming Li, PhD

lishiming81@163.com+86-10-58269920

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026