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Safety and Efficacy of Modified ICL implantation

Safety and Efficacy of Modified ICL implantation

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044000
Enrollment
Unknown
Registered
2021-03-06
Start date
2021-07-01
Completion date
Unknown
Last updated
2021-07-12

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

Conditions

High Myopia

Interventions

Experimental group:one incision non-visco device ICL inplantation
Control group:ICL inplanted with ophthalmic visco device

Sponsors

Changsha Aier Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
21 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Age range between 21-45 years old with the progression of myopia stable (the degree increase in recent one year = 6.00D; 3. Anterior chamber depth >= 2.8mm, peripheral chamber angle >= 30 degrees and corneal endothelial cell density >= 2000 cells · mm-2; 4. Preoperative intraocular pressure < 21mmhg (1kPa = 7.5mmhg); 5. The subjects themselves had reasonable expectations of the operation before the operation, fully understand the possible complications of the surgery, sign the informed consent in person, and are able to be followed-up on time.

Exclusion criteria

Exclusion criteria: 1. Pupil diameter > 7.5mm; 2. There are organic or morphological lesions caused by high myopia, such as posterior scleral staphyloma, primary open-angle glaucoma, macular splitting, cystoid macular edema, etc; 3. The subjects have combined condition of any ocular or systemic diseases that may affect the refractive status of the eyes. For example, Marfan's syndrome, retinopathy of prematurity, diabetes, etc; 4. The subjects who is incline to have scar constitution or has systemic collagen disease, etc; 5. Preoperative primary glaucoma and intraocular pressure > 21mmhg caused by various reasons.

Design outcomes

Primary

MeasureTime frame
corneal endothelial cell density;Time of Surgery;

Secondary

MeasureTime frame
IOP;UCVA, BCVA;Vault;

Countries

China

Contacts

Public ContactDing Lin

Changsha Aier Eye Hospital

dlinoph@163.com+86 13787255158

Outcome results

None listed

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