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Multicenter clinical trial to evaluate the efficacy and safety of PRL-S5

Multicenter clinical trial to evaluate the efficacy and safety of PRL-S5

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066095
Enrollment
Unknown
Registered
2022-11-24
Start date
2022-11-30
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Myopia

Interventions

Part A: Experimental group:Implantation of PRL-S5
Part A: Control group:Implantation of ICL-V4C
Part B: Single arm:Implantation of PRL-S5

Sponsors

Eye and Ear, Nose, and Throat Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: (1) Aged 20 to 50 years old, male or female; (2) With myopia between -3.0D and -28.0D; (3) BCDVA=0.2 (decimal visual acuity) (4) Be able to understand the purpose of the trial, participate voluntarily and sign the informed consent form by the patient himself or his legal guardian, and be able to complete the postoperative follow-up on time.

Exclusion criteria

Exclusion criteria: (1) Combined with other eye diseases judged by the investigator to be unsuitable for phakic refractive lens implantation, such as Marfan syndrome, pseudoexfoliation syndrome, pigment dissemination syndrome,iritis, uveitis, retinal detachment, macular edema, diabetic retinopathy, keratoconus, corneal endothelial dystrophy, cataract, glaucoma, high intraocular pressure, etc.; (2) There is a history of trauma that affects visual function or inner eye surgery; (3) Central anterior chamber depth < 2.5mm; (4) The anterior chamber angle is narrow; (5) Corneal endothelial cell count is less than 2000 cells/mm2; (6) Subjective refraction: cylindrical degree = 1.5D; (7) Unstable refractive state (the change in refractive error is larger than 0.5D in the past year); (8) There is damage or slack in suspensory ligament, or aphakic, or with lens subluxation; (9) Other circumstances judged by the investigator to be unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
The effective rate of the products at 6 months after surgery;—

Secondary

MeasureTime frame
The BCDVA, refraction, UCDVA and glasses independence rate of the surgical eye at each visit after surgery;—

Countries

China

Contacts

Public ContactXingtao Zhou

Eye and Ear, Nose, and Throat Hospital, Fudan University

doctzhouxingtao@163.com+86 21 64377134

Outcome results

None listed

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