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

Phase 4

Conditions: Health Condition 1: H259- Unspecified age-related cataract

Registration Number: CTRI/2022/01/039218

Lead Sponsor: BIOTECH EUROPE MEDITECH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Patient with bilateral age related senile cataract

2. grade of cataract permitting optical biometry

3. no ocular/systemic contraindication for surgery

4. a patient with preoperative corneal astigmatism less than 1D in each eye

5. normal macular functions with normal anantomy of macula as seen on optical coherence tomography

6. no history or evidence of ocular anatomical or functional disorders other than cataract including strabismus neuro-ophthalmological disorders of optic nerve or high visual functions corneal pathologies disorders of uvea vitreous pathologies retinal disorders

7. no systemic contraindications to surgery under local anaesthesia

8. patient willing to undergo the investigations and comply with the follow-up schedule

Exclusion Criteria

1. cataract precluding optical biometry

2. posterier-segment pathology

3. media opacity other than cataract

4. corneal higher order aberrations more than 0.3 micron as measured on ray-tracing wavefront aberrometer

5. patients with potential for intraoperative complications such as floppy iris syndrome and pseudo-exfoliation syndrome

6. cases where intra-operative complications compromise IOL placement with proper centration in the capsule bag

7. patient unwilling to undergo the required investigations or follow-up

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. visual acuity <br/ ><br>uncorrected and best corrected distance intermediate and near visual acuity <br/ ><br>2. quality of visionTimepoint: 1. Pre-operative visit <br/ ><br>2. Operative visit <br/ ><br>3. Post-operative visit 1 - Day 1 <br/ ><br>4. Post-operative visit 2 - 1 month <br/ ><br>3. Post-operative visit 3 - 3 months <br/ ><br>3. Post-operative visit 4 - 6 months <br/ ><br>3. Post-operative visit 5 - 12 months

Secondary Outcome Measures