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

Capital Medical University

Status and phase: Unknown; Phase 2

Conditions: Axial Elongation; Myopia Progression; Adults; High Myopia; Posterior Scleral Reinforcement

Treatments: Procedure: Posterior scleral reinforcement

Study type: Interventional

Funder types: Other

Identifiers

NCT03381079

TRECKY2017-049

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Surgical group

Experimental group

Description:

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

Treatment:

Procedure: Posterior scleral reinforcement

Control group

No Intervention group

Description:

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