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A non-inferiority, multi-center, randomized, single-blind, positive parallel controlled clinical trial of scleral biological patch for posterior scleral reinforcement in the control of progressive high myopia

A non-inferiority, multi-center, randomized, single-blind, positive parallel controlled clinical trial of scleral biological patch for posterior scleral reinforcement in the control of progressive high myopia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110824
Enrollment
Unknown
Registered
2025-10-21
Start date
2025-10-24
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Progressive high myopia

Interventions

Intervention Group:scleral biological mesh
Control Group:Allograft repair material of PSR

Sponsors

The Eye Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years old, gender is not limited; 2. Progressive high myopia, target eye equivalent spherical lens =27mm, and continuous progression of myopia within the last year; 3. Best-corrected visual acuity > 0.2 in the target eye; 4. The patient or guardian voluntarily participates in this trial and signs an informed consent form.

Exclusion criteria

Exclusion criteria: 1. A clear history of ocular trauma or ophthalmic surgery within the past 6 months; 2. Non-axial myopia such as simple myopia, curvature myopia, exponential myopia, and myopia caused by other syndromes such as Marfan syndrome, Stickler syndrome, etc. 3. Severe fundus lesions such as macular retinoschisis, hole and retinal detachment secondary to progressive high myopia; (4) combined with glaucoma, keratoconus, congenital ptosis and other eye diseases; 5. Acute or chronic inflammation or tumor of the eyeball or its surrounding tissue; 6. Systemic diseases such as leukemia, collagen disease, diabetic retinopathy, nephrotic retinopathy, uncontrolled hypertension; 7. Severe allergic constitution or intolerance to anesthetic drugs; 8. Women who are pregnant, planning to become pregnant, or breastfeeding; 9. Participated in other clinical trials within the past 3 months; 10. Other conditions considered by the investigator to be unsuitable for participation in the trial, such as inability to receive complete follow-up, inability to cooperate with medical treatment due to mental and behavioral abnormalities, and history of previous eye surgery that may affect the trial results. If you meet any of the above criteria, you will not be enrolled.(YNMT)·

Design outcomes

Primary

MeasureTime frame
The proportion of effective axial length control at 12 months after surgery;

Secondary

MeasureTime frame
Axial length change index;

Countries

China

Contacts

Public ContactJia Qu

The Eye and Optometry Hospital affiliated to Wenzhou Medical University

jia.qu@eye.ac.cn+86 138 0689 8805

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026