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Assessment of visual outcomes of a new trifocal intraocular lens for distance, intermediate and nearvisual acuity.

Phase 4
Conditions
Health Condition 1: H259- Unspecified age-related cataract
Registration Number
CTRI/2024/08/071812
Lead Sponsor
Biotech vision care pvt ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

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 study 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

Exclusion Criteria

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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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