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

NCT ID: NCT03381079

Last Updated: 2017-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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High Myopia Posterior Scleral Reinforcement Adults Axial Elongation Myopia Progression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Surgical group

In this arm, the adults with high myopia will be given posterior scleral reinforcement.

Group Type EXPERIMENTAL

Posterior scleral reinforcement

Intervention Type PROCEDURE

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.

Control group

In this arm, the adults with high myopia will not be given any surgical treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tongren Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shi-Ming Li

Vice director of Ophthalmology clinical research center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ningli Wang, PhD

Role: STUDY_CHAIR

Beijing Tongren Eye Center, Beijing Tongren Hospital

Central Contacts

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Shi-Ming Li, PhD

Role: CONTACT

Phone: +86-10-58269920

Email: [email protected]

Other Identifiers

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TRECKY2017-049

Identifier Type: -

Identifier Source: org_study_id