Health Condition 1: H259- Unspecified age-related cataract
Conditions
Interventions
Intervention1: OPTIFLEX TRIO Intraocular Lenses (IOLs): OPTIFLEX TRIO Intraocular Lenses (IOLs) are Trifocal hydrophobic aspheric foldable single piece posterior chamber IOLs.
Duration of study is 2
Sponsors
Biotech vision care pvt ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult patient, 18 years old or older will be enrolled in the study 2. Patient with cataract 3. Calculated IOL power is within the range of the study IOL 4. Patients must sign and be given a copy of the written Informed Consent form 5. Clear intraocular media other than cataract 6. Patient willing to undergo the investigations and comply with the follow-up schedule 7. 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. Previous intraocular or corneal surgery 2. Traumatic cataract 3. Pregnancy or lactation 4. Concurrent participation in another drug or device investigation 5. Instability of keratometry or biometry measurements 6. Irregular astigmatism 7. More than 1 D of pre-operative corneal astigmatism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uncorrected Intermediate Visual Acuity (UIVA) (Photopic)Timepoint: Measured at Time frame: Monocular Post-operative: 120-180 days, 330-420 days Binocular: Post-operative 330-420 days] | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Shreyas Ramamurthy
The Eye Foundation
Outcome results
None listed