Health Condition 1: Z961- Presence of intraocular lens
Conditions
Interventions
Intervention1: EDOF Hydrophilic Acrylic Foldable IOL(Omni Lens Pvt. Ltd.): Route of Administration : Intraocular, Duration of Therapy : One Time insertion, Dose : NA , Frequency : NA
Control Intervent
Sponsors
Omni Lens Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Cataract (Unilateral/Bilateral) 2.Calculated EDOF IOL power is within the range of the Study device i.e. 8 to 30 D (+3.00D) 3.The patient or his/her legally authorized representative (if applicable) agrees to provide written informed consent. 4.Clear intraocular media other than cataract 5.The patient is willing to comply with protocol specified follow-up evaluations. #If any of the above criteria is answered No , the subject may not be enrolled in the study.
Exclusion criteria
Exclusion criteria: 1. Previous intraocular or corneal surgery 2. Traumatic cataract and/or existing inflammation 3. Pregnancy or lactation 4. Concurrent participation in another drug or device investigation 5. At the time of surgery conditions such as zonular instability, need for iris manipulation, capsular fibrosis or other opacity and inability to fixate EDOF IOL in desired position. 6. Instability of keratometry or biometry measurements 7. Irregular astigmatism 8. History of intraocular Inflammation 9. Subjects who may be reasonably expected to require secondary surgical intervention at any time during the investigation (other than YAG capsulotomy). 10. Gonioscopy Abnormalities 11. More than 1 D of pre-operative corneal astigmatism 12. Minor under the age of 18 13. Those who are participating in other clinical trials of drugs or medical devices. # If any of the above criteria is answered YES , the subject may not be enrolled in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Best-Corrected distance visual acuity(CDVA) 2. Distance -corrected intermediate visual acuity(DCIVA) 3. Distance-corrected near visual acuity(DCNVA)Timepoint: 1. Best-Corrected Distance Visual Acuity (CDVA) [Time frame: At Baseline, 1 week,4 weeks and 18 weeks) 2.Distance corrected Intermediate visual Acuity (DCIVA) [Time frame: 4weeks and 18 weeks] 3.Distance corrected Near visual Acuity (DCNVA) [Time frame: 4 weeks and 18 weeks] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Depth of focus curve Test 2. Adverse event rates 3. Far Contrast Sensitivity 4. Sign of InflammationTimepoint: 1. Depth of focus curve Test (after 18 weeks) 2. Adverse event rates (at baseline, 1 day,1week, 4 weeks & 18 weeks) 3. Far Contrast Sensitivity (after 18 weeks) 4. Sign of Inflammation (1 day, 1 week, 4 weeks & 18 weeks) | — |
Countries
India
Contacts
Public ContactDr Uday R Gajiwala
Divyajyoti Trust- Tejas Eye Hospital
Outcome results
None listed