To evaluate clinical outcomes and patient satisfaction with Trifocal Intraocular lens
- Conditions
- Health Condition 1: H259- Unspecified age-related cataract
- Registration Number
- CTRI/2024/01/061967
- Lead Sponsor
- Tirupati Eye Centre and research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Adult patient, 18 years old or older will be enrolled in the study
2. Patient with cataract
3. Calculated IOL power is within the range of the investigational IOL
4. Patients must sign and be given a copy of the written Informed Consent form
5. Clear intraocular media other than cataract
6. Patient willing to undergo the investigations and comply with the follow-up schedule
7. 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
1. Previous intraocular or corneal surgery
2. Traumatic cataract
3. Pregnancy or lactation
4. Concurrent participation in another drug or device investigation
5. Instability of keratometry or biometry measurements
6. Irregular astigmatism
7. More than 1 D of pre-operative corneal astigmatism
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ncorrected Intermediate Visual Acuity (UIVA) (Photopic) <br/ ><br>Timepoint: Post-operative: 120-180 days <br/ ><br>
- Secondary Outcome Measures
Name Time Method Visual Acuity, Subjective Refraction,Intraocular Pressure, Keratometry, Corneal Status, Signs of InflammationTimepoint: [Time Frame: Pre-operative, Postoperative 1-2 days, 7-14 days, 30-60 days, 120-180 days and 330-420 day]