Health Condition 1: H259- Unspecified age-related cataract
Conditions
Interventions
Intervention1: Eyecryl sert pre-loaded delivery intraocular lens: EYECRYL SERT is a pre-loaded, Aspheric Natural Yellow acrylic, foldable,
single piece posterior chamber EDOF (extended depth of foc
Sponsors
Biotech vision care pvt ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 years or older 2. Good general and ocular health who had a cataract in one eye or both eyes 3. Patients willing to attend all follow-up appointments 4. Patients must sign and be given a copy of the written Informed Consent form 5. Patients willing comply with the study procedures 6. 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. Systemic disease that affect the cornea 2. Inflammation or edema of the cornea 3. Previous corneal treatment 4. Previous retinal detachment 5. Pregnancy or lactation 6. Any condition observed before or during surgery that may affect the success of the cataract surgery 7. Evidence of trauma on bio microscopic examination 8. Participated in any study during the use of the study device 9. Vulnerable population 10. Corneal astigmatism greater than 1D.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate safety in patients implanted with different intraocular lens delivery systems.Timepoint: intra- operative, day 1 and day 30 7 days post-surgery or as and when occurs | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate clinical acceptability, delivery characteristics and clinical outcomes in patients implanted with different intraocular lens delivery systems.Timepoint: intra- operative, day 1 and day 30 7 days post-surgery or as and when occurs | — |
Countries
India
Contacts
Public ContactBhargav Joshi
BIOTECH VISION CARE PVT LTD
Outcome results
None listed