H52
Conditions
Interventions
Group 1: All subjects will be implanted binocularly with the Implantable Phakic Contact Lens (IPCL V2.0).
Examination schedule:
Pre-operative Visit
Operative Visit
Post-operative Visit -1 Day
Post-op
Sponsors
Care Group, India
Eligibility
Sex/Gender
All
Age
21 Years to 45 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary effectiveness endpoint is a gain of 2 or more lines in uncorrected distance visual acuity (UCDVA). Uncorrected distance visual acuity is tested using ETDRS charts at 4 meters. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Assessments: - Adverse Events - Device Deficiency | — |
Countries
Germany
Outcome results
None listed