Health Condition 1: H259- Unspecified age-related cataract
Conditions
Interventions
Intervention1: OPTIFLEX TRIO Intraocular lens: OPTIFLEX TRIO Intraocular Lenses (IOLs) are Trifocal hydrophobic aspheric foldable single piece posterior chamber IOLs. These IOLs are designed to be sur
Sponsors
Tirupati Eye Centre and research Institute
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 investigational 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: Post-operative: 120-180 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Acuity, Subjective Refraction,Intraocular Pressure, Keratometry, Corneal Status, Signs of InflammationTimepoint: [Time Frame: Pre-operative, Postoperative 1-2 days, 7-14 days, 30-60 days, 120-180 days and 330-420 day] | — |
Countries
India
Contacts
Public ContactDr Mohita Sharma
Tirupati Eye Centre and research Institute
Outcome results
None listed