Prospective, multicenter, post-marketing study to evaluate the effectiveness of a monofocal implantable phakic contact lens (IPCL) in myopic and hyperopic patients, with and without astigmatism

Phase 4

Conditions: H52
Disorders of refraction and accommodation

Registration Number: DRKS00024073

Lead Sponsor: Care Group, India

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 40

Inclusion Criteria

• Baseline Refractive Errors between +2.00D and +6.50D and -6.00D and -30.00D of myopia/hyperopia
• Stable refraction for 12 months before study enrollment
• Contact lens not worn for at least 2 weeks (rigid and toric contact lenses) or 3 days (soft contact lenses) prior to the first refraction
• Patients with a BSCVA of at least 20/40
• All patients to be enrolled in the study will be between 21 and 45 years old
• Patients willing to have IPCL implanted in both eyes
• Patient should be able to comply with the standardized post-operative follow-up visits through the 3-year study period
• Patient able to give consent

Exclusion Criteria

• Anterior Chamber depth < 2.8 mm
• Endothelial Cell Density (ECD) less than 2000 cells / mm3
• History and/or clinical signs of iritis/uveitis, diabetic retinopathy, glaucoma, previous ocular surgery, ocular hypertension, progressive sight-threatening disease other than myopia, pseudoexfoliation, and/or insulin- dependent diabetes, keratoconus, monocular vision
• Patient is pregnant, plans to become pregnant or is lactating during the course of the study, or has any condition associated with the fluctuation of hormones that could lead to refractive changes
• Participation in other clinical trials

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary effectiveness endpoint is a gain of 2 or more lines in uncorrected distance visual acuity (UCDVA).<br>Uncorrected distance visual acuity is tested using ETDRS charts at 4 meters.

Secondary Outcome Measures