None listed
Conditions
Interventions
Intervention1: Eyecryl Phakic Toric iol: Phakic Toric intraocular lenses are clear implantable lenses that are surgically placed either in anterior chamber (AC) or posterior chamber (PC) without remov
Sponsors
Research Foundation Nethradhama Eye Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with myopia or myopic astigmatism of any degree 2. Age 21 years or above 3. Calculated IOL Power is within the range of the investigational IOL 4. Corneal Cylindrical error within the range defined in the clinical investigation plan 5. UCVA 0.5 or worse 6. Stable refraction (±0.5D; ±1.0D for higher refractive errors), as expressed by manifest refraction spherical equivalent (MRSE) for a minimum 12 months prior to surgery, verified by consecutive refractions and/or medical records or prescription history 7. Subject, who is a current contact lens wearer, needs to demonstrate a stable refraction (±0.5D) expressed as MRSE, on two consecutive examination dates and stability of the refraction is determined by the following criteria: a. Contact lenses were not worn for at least 2 weeks or 3 days prior to the first refraction b. Two refractions were performed at least 7 days apart 8. Signed informed consent form 9. Expected dilated pupil size at least large enough to visualize the axis marking 10. Patients who are willing to attend all follow-up appointments 11. Patients must sign and be given a copy of the written Informed Consent form 12. Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study
Exclusion criteria
Exclusion criteria: 1. Patients who are younger than 21 years old. 2. Subject has acute and chronic disease or illness that would increase the operative risk or confound the outcomes of the Evaluation 3. Subject is taking any systematic medication that can confound the outcome of the study or increase the risk to the subjectâ??s health 4. Subject has ocular condition that can predispose for future complications 5. Subject has had previous intraocular or corneal surgery 6. Subject with less than the minimum endothelial cell density at 2000 cells/mm2 at the time of enrollment. 7. Subject is pregnant, plans to become pregnant, or is lactating during the course of the Evaluation or has another condition associated with fluctuation of hormones 8. ACD from corneal endothelium 9. Concurrent participation in another drug or device Evaluation 10. No cataract of any grade. 11. Coefficient of variation of endothelial cell area >0.45 12. Percent Hexagonality of endothelial cell shape 13. Monocular subject Vulnerable subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To develop and validate sizing formulae for EYECRYLTM Phakic and EYECRYLTM Phakic Toric intraocular lenses based on prospective analysis of a population of eyes on different diagnostic biometry techniques. Timepoint: ¬ Screening/Pre-operative/Baseline Visit ¬ Surgery/Intra-operative ¬ Post-operative 1 Day ¬ Post-operative 7 Days ± 2 Days ¬ Post-operative 1 Month ± 7 Days ¬ Post-operative 3 Months ± 14 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety and efficacy of EYECRYLTM Phakic and EYECRYLTM Phakic Toric intraocular lens.Timepoint: ¬ Screening/Pre-operative/Baseline Visit ¬ Surgery/Intra-operative ¬ Post-operative 1 Day ¬ Post-operative 7 Days ± 2 Days ¬ Post-operative 1 Month ± 7 Days ¬ Post-operative 3 Months ± 14 Days | — |
Countries
India
Contacts
Public ContactDR SAHITI SALGUTI
Nethradhama superspeciality eye hospital
Outcome results
None listed