Health Condition 1: H524- Presbyopia Health Condition 2: H524- Presbyopia
Conditions
Interventions
Intervention1: Presbyopic IPCL Implant: Presbyopic IPCL will be implanted for correction of Presbyopia with Moderate Myopia and Hyperopia
Control Intervention1: NA: NA
Sponsors
Care Group India
Eligibility
Inclusion criteria
Inclusion criteria: Bilateral Baseline Refractive Errors between -5.0 to +5.0 D Sph of myopia/Hyperopia (manifest refraction spherical equivalent [MRSE]). A maximum of 4.0 D of manifest refractive cylinder have documented stable refraction for 12 months before study enrollment (+ 0.5 D, + 1.0 D for high refractive errors) BSCVA of at least 20/100 in the study eye Patient should be able to comply with the standardized postoperative follow-up visits through the 3-year study period
Exclusion criteria
Exclusion criteria: Anterior Chamber depth 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Outcomes: Lens opacity analysis (Lens Opacity Classification System III [LOCS III]) / Pentacam crystalline Lens Endothelial Cell Density and Morphology (CD, CV) Measurement of IOP ASOCT â?? IPCL vaulting Effectiveness Outcomes: Uncorrected visual acuity (UCVA) Distance and near (30cm and 60cm) Best Spectacle Corrected Visual Acuity (BsCVA) for distance and for nearTimepoint: Day 1 1 Week (5 to 9 days) 1 Month (3 to 5 weeks) 3 Months (10 to 14 weeks) 6 Months (21 to 26 weeks) 12 Months (11 to 14 months) 24 Months (23 to 27 months) 36 Months (35 to 39 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Anterior Chamber Inflammation (Aqueous cells, flare) Pigment Dispersion (Iris transillumination defects, Pigment dispersion on endothelium, phakic lens surface, clear lens surface and anterior chamber angle) Lens thickness Macular Thickness Changes (Posterior Segment OCT) Contrast sensitivity Glare acuity Operative and post-operative complications Timepoint: Day 1 1 Week (5 to 9 days) 1 Month (3 to 5 weeks) 3 Months (10 to 14 weeks) 6 Months (21 to 26 weeks) 12 Months (11 to 14 months) 24 Months (23 to 27 months) 36 Months (35 to 39 months) | — |
Countries
India
Contacts
Public ContactProf Jeewan Singh Titiyal
AIIMS
Outcome results
None listed