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A Prospective Observational Study on the Long-term Stability of ICL V4c and Changes in Retinochoroidal Perfusion after Implantation

A Prospective Observational Study on the Long-term Stability of ICL V4c and Changes in Retinochoroidal Perfusion after Implantation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500109035
Enrollment
Unknown
Registered
2025-09-10
Start date
2025-09-12
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

High Myopia

Interventions

Implantation of Implantable Collamer Lens (ICL V4c) Group:NA

Sponsors

The Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 50 years, with no gender limitation; 2. Stable refractive status (annual refractive change less than 0.50 diopters over the past two years); 3. Scheduled to undergo ICL V4c implantation, having completed a comprehensive preoperative evaluation and meeting all surgical indications; 4. No significant fundus pathology and normal ocular anatomical development; 5. Able to comply with the scheduled preoperative and postoperative examination protocols and has signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Individuals with a history of or currently suffering from any serious clinical disorders affecting the circulatory, endocrine, neurological, gastrointestinal, respiratory, hematologic, immunologic, psychiatric, or metabolic systems, or any other conditions that may interfere with study outcomes; 2. Patients with active ocular infections or those undergoing anti-inflammatory treatments; 3. Pregnant or breastfeeding women; 4. Individuals with severe psychological or cognitive impairments that prevent understanding of study requirements or provision of informed consent; 5. Subjects who, for any other reason, are deemed unsuitable for study participation by the investigators.

Design outcomes

Primary

MeasureTime frame
Retinal Thickness;Vessel Density;Choroidal Vascularity Index (CVI);Choroidal Thickness (CT);Vault;ICL Location;Higher Order Aberrations;

Secondary

MeasureTime frame
Visual Acuity Test;Intraocular Pressure (IOP);

Countries

China

Contacts

Public ContactHan Wei

The Second Affiliated Hospital, School of Medicine, Zhejiang University

w2180102857@outlook.com+86 188 8854 1379

Outcome results

None listed

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