Health Condition 1: H521- Myopia
Conditions
Interventions
Intervention1: EYECRYL PHAKIC Intraocular Lens: Diopter Range: +10.0 D to -25.0 D (with 0.5D step)
Control Intervention1: Visian ICL: Diopter Range: -3.0 to -16.0 D (with 0.5D step)
Sponsors
Biotech Vision Care Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients 21 years. 2. Calculated IOL Power is within the range of the study IOLs. 3. The ACD from endothelium is between 2.80 mm and 4.50 mm. 4. The white to white (WTW) is either between 9.56 mm and 10.52 mm or between 12.15 mm and 12.92 mm. 5. Subject falling under spherical power range of 0 D to -25.0 D. 6. Subject has monocular UDVA 0.5 LogMAR or worse. 7. Subject has had stable refraction history (within 0.5 D each for spherical power and cylindrical power) for a minimum of 12 months prior to surgery, verified by consecutive refractions and/or medical records or prescription history. 8. The subject, who is a current contact lens wearer, needs to demonstrate 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. 9. The subject, who is expected to have the residual postoperative cylindrical refractive error of >=1D, has been given the opportunity to experience his/her best spectacle vision with the anticipated correction. 10. Patients 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 childbearing potential and male participants whose partner is of childbearing potential must be willing to ensure that they or their partner use effective contraception during the study.
Exclusion criteria
Exclusion criteria: 1. Subject with acute and chronic disease or illness that would increase the operative risk or confound the outcomes of the evaluation. 2. The subject taking systematic medication that can confound the outcome of the study or increase the risk to the subject. 3. Subject with ocular condition that may predispose the subject to future complications. 4. Subject with previous intraocular or corneal surgery. 5. Subject with less than the minimum endothelial cell density of 2000 cells/mm² at the time of enrollment. 6. Pregnant or planning to become pregnant, or is lactating during the course of the evaluation. 7. Other conditions associated with fluctuation of hormones. 8. ACD measured from the endothelium lower than 2.8 mm. 9. Concurrent participation in another drug or device evaluation. 10. Cataract of any grade. 11. Coefficient of variation of endothelial cell area greater than 0.45. 12. Percent Hexagonality of endothelial cell shape less than or equal to 45%. 13. Monocular subject. 14. Vulnerable subjects as defined in section 11.3.10.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate and compare the efficacy and the residual refractive error of EYECRYL TM Phakic IOL versus Visian ICL TM in moderate to high myopia patientsTimepoint: 1, 3, 6 & 12 months Post-operative | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate and compare the safety of EYECRYL TM Phakic IOL versus Visian ICL TM in moderate to high myopia patients.Timepoint: 1, 3, 6 & 12 months Post-operative | — |
Countries
India
Contacts
Public ContactDr Bhargav Joshi
BIOTECH VISION CARE PVT. LTD
Outcome results
None listed