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A Multicenter, Non-interventional, Retrospective Clinical Observation Study on the Efficacy of EVO+ ICL (V5) for Correcting Myopia in the Chinese Population

A Multicenter, Non-interventional, Retrospective Clinical Observation Study on the Efficacy of EVO+ ICL (V5) for Correcting Myopia in the Chinese Population

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600127795
Enrollment
Unknown
Registered
2026-07-07
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

Myopia

Interventions

EVO+ ICL (V5) Central-Hole Posterior Chamber Phakic Intraocular Lens Implantation group:None

Sponsors

Eye & ENT hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Age at surgery ranged from 18 to 45 years old. 2. Preoperative refractive error: myopia from -0.5 D to -18.0 D, with or without astigmatism = 6.0 D. 3. Bilateral eyes implanted with either EVO+ ICL (V5) or EVO+ Toric ICL (V5).

Exclusion criteria

Exclusion criteria: 1. Patients with low/abnormal corneal endothelial cell density, Fuchs endothelial corneal dystrophy, or other corneal diseases. 2. Ocular hypertension in either eye. 3. Presence of any type of cataract in the operative eye, or non-traumatic cataract in the fellow eye. 4. Primary open-angle glaucoma or narrow-angle glaucoma. 5. Narrow anterior chamber angle (e.g., grade less than ? confirmed by gonioscopy). 6. Pregnancy or lactation period. 7. History or presence of any ocular disease that is expected to result in a postoperative visual acuity worse than 0.477 logMAR (20/60 Snellen) or inability to achieve better postoperative visual sensitivity. 8. Anterior chamber depth (ACD) of the eyes scheduled for lens implantation, measured from the corneal endothelium to the anterior lens capsule, less than 2.80 mm.

Design outcomes

Primary

MeasureTime frame
uncorrected distance visual acuity;corrected distance visual acuity;Refraction;

Secondary

MeasureTime frame
Incidence rate of ocular adverse events;intraocular pressure;Subjective Visual Quality Assessment;Corneal endothelium density;Vault;

Countries

China

Contacts

Public ContactWang Xiaoying

Eye & ENT hospital of Fudan University

xiaoying02.wang@fdeent.org+86 21 64377134

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026