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

Assessment of visual performance of a new trifocal intraocular lens for visual quality and safety (Optiflex TRIO, Biotech Europe Meditech Inc. Ltd.)

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/01/039218

Enrollment

100

Registered

2022-01-06

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H259- Unspecified age-related cataract

Interventions

Intervention1: cataract surgery with intraocular trifocal lens implantation: cataract surgery with intraocular trifocal lens implantation(optiflex trio) which will remain in the patients eye permanent

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. visual acuity uncorrected and best corrected distance intermediate and near visual acuity 2. quality of visionTimepoint: 1. Pre-operative visit 2. Operative visit 3. Post-operative visit 1 - Day 1 4. Post-operative visit 2 - 1 month 3. Post-operative visit 3 - 3 months 3. Post-operative visit 4 - 6 months 3. Post-operative visit 5 - 12 months	—

Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactNamrata Sharma

Dr. R. P. Centre for Ophthalmic Sciences

namrata.sharma@gmail.com9810856988

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026