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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical group | Experimental | In this arm, the adults with high myopia will be given posterior scleral reinforcement. |
|
| Control group | No Intervention | In this arm, the adults with high myopia will not be given any surgical treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posterior scleral reinforcement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cycloplegic autorefraction | Level of myopia and myopia progression as assessed by autorefraction | 2 years |
| Axial length | Longth of the eyeball as assessed by IOL Master or Lenstar | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events | Bleeding, inflammation or retinal detachment as assessed by B scan, slitlamp, etc. | 2 years |
| Visual acuity | An index for visual function measured by visual acuity chart |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shi-Ming Li, PhD | Contact | +86-10-58269920 | lishiming81@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ningli Wang, PhD | Beijing Tongren Eye Center, Beijing Tongren Hospital | Study Chair |
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| 2 years |