Health Condition 1: H251- Age-related nuclear cataract
Conditions
Interventions
Intervention1: Model â?? B0762262 - Clear Cornea - Single bevel- Bevel
Up: Class B device, Polycarbonate and Stainless Steel Grade- SS 420 diameter 2.2mm
Control Intervention1: Model â?? AA562022 - An
Sponsors
None
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18 year or greater 2. Cataract of any kind 3. Patient willing to participate and sign informed consent to participate in study and to use device related data for scientific purpose 4. Patient willing to come for all post-operative follow-up 5. 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. Received (or is planning to receive) anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti-inflammatory drugs [oral/ injectable corticosteroids or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)], or other substances known to increase coagulation time from 10 days pre- to 3 days post injection 2. Traumatic cataract 3. Pregnancy (as stated by patient) or lactation 4. Concurrent participation in another drug or device investigation. 5. Patient receiving chloroquine treatment 6. Subjects with any systemic and metabolic disease that could increase operative risk or confound the outcome 7. Active ocular disease in the operative eye other than cataract 8. Vulnerable subjects 9. Patient having Microphthalmia 10. Patient having chronic uveitis 11. Patient suffering from Corneal dystrophy or endothelial insufficiency 12. Patient having active ocular diseases (active diabetic retinopathy, uncontrolled glaucoma) 13. Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study 14. Patient who sensitive or allergic to metals
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean performance of both ophthalmic knives will be evaluated by overall surgeon satisfaction score in terms of following parameters [Time Frame: Intra-Operative] The sharpness of blade, ease of handling the blade, smoothness of incision creation, control while creating the wound.Timepoint: Intra-Operative, Post-Operative day 1 & day 30. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Wound integrity 2) Incision size accuracy 3) Astigmatism: Measurement by Pentacam. Following parameter will be measured - K1, K2 & K mean. Timepoint: Intra-Operative, Post-Operative day 1 & day 30. | — |
Countries
India
Contacts
Public ContactProf A Heber
Dr. Agarwals Eye Hospital
Outcome results
None listed