Health Condition 1: H259- Unspecified age-related cataract
Conditions
Interventions
Intervention1: PHACOEMULSIFICATION MACHINE WITH ACCESSORIES (LIBERTY 1): Duration of therapy as per below schedule.
? Screening/ Pre-Operative/
Baseline Visit
? Surgery/Intra - Operative
? Day 1 Po
Sponsors
Grewal Eye Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1. Cataracts for which cataract extraction and posterior chamber IOL implantation have been planned & possible 2. Availability, willingness, ability and sufficient cognitive awareness to comply with study requirements, examination procedures and visits 4. Be willing to provide informed consent and authorization to disclose protected health information or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical procedures in the governing countries 5. A transparent central cornea 6. A preoperative central endothelial cell count of =1500 cells per square millimeter 7. Patients willing to attend all follow-up appointments 8. Patients must sign and be given a copy of the written Informed Consent form
Exclusion criteria
Exclusion criteria: 1. Preoperative ocular pathology that can affect visual acuity 2. Corneal irregularities such as keratoconus, corneal dystrophy, corneal opacities 3. Previous intraocular or corneal surgery 4. Other ocular surgery at the time of the cataract extraction 5. Subject with acute and chronic disease or illness that would increase the operative risk or confound the outcomes of the evaluation 6. Subject with primary open angle or narrow angle glaucoma 7. Patient with cardiac pacemaker 8. Previous or pre-existing ocular disease that would preclude post operative visual acuity of 20/60 or better subject with Keratoconus, pellucid Marginal degeration & other corneal ectasia disease. 9. Subject having ocular hypertension in either eye 10. Subject taking systematic medication that can confound the outcome of the study or increase the risk to the subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Overall Satisfaction Level: Grading from Low to High on 1 to 5 Scale Overall surgeon satisfaction using a Rating Score (1 to 5): Overall Surgeon satisfaction score will be measured by evaluating composite score of below mentioned criteria (1 to 5) Composite score will be mean score of below mention criteria: 1)Ultrasound Efficiency 2)Chamber stability 3)Followability Timepoint: Intra operative | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall satisfaction level for GUI screen operation 2. Surgical Time to emulsify nucleus (minutes) 3. CDVA 4. Post-operative central corneal thickness Timepoint: Pre-op, Intra-op & Post – op 1 month | — |
Countries
India
Contacts
Public ContactDr Sartaj Singh Grewal
Grewal Eye Institute
Outcome results
None listed