A clinical study to evaluate the performance and safety of phaco machine.
- Conditions
- Health Condition 1: H259- Unspecified age-related cataract
- Registration Number
- CTRI/2023/03/050394
- Lead Sponsor
- Grewal Eye Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Overall Satisfaction Level: Grading from Low to High on 1 to 5 Scale <br/ ><br>Overall surgeon satisfaction using a Rating Score (1 to 5): <br/ ><br>Overall Surgeon satisfaction score will be measured by evaluating composite score of below mentioned criteria <br/ ><br>(1 to 5) Composite score will be mean score of below mention criteria: <br/ ><br>1)Ultrasound Efficiency <br/ ><br>2)Chamber stability <br/ ><br>3)Followability <br/ ><br>Timepoint: Intra operative <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.Overall satisfaction level for GUI screen operation <br/ ><br>2.Surgical Time to emulsify nucleus (minutes) <br/ ><br>3.CDVA <br/ ><br>4.Post-operative central corneal thickness <br/ ><br>Timepoint: Pre-op, Intra-op & Post – op 1 month