Quality of vision in patients receiving new Multifocal Intraocular Lens to achieve high eyeglass independence after cataract surgery

ASSESSING THE VISUAL PERFORMANCE OF HANITA LENSES INTENSITY SL INTRAOCULAR LENS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/08/027483

Enrollment

Registered

2020-08-31

Start date

Unknown

Completion date

Unknown

Last updated

2023-03-06

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

Conditions

Health Condition 1: H251- Age-related nuclear cataract

Interventions

Intervention1: Intensity SL IOL: Intensity SL IOL, is a diffractive aspheric, foldable, one piece lens designed for micro- incision cataract surgery (MICS), through sub-2mm incisions. Control Interven

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age over 45 years and under 75 years. 2. Patients with bilateral age related cataracts, require bilateral cataract phacoemulsification combined Intraocular Lens implantation; 3. Patients with axial length of 22-24.5mm. 4. Normal corneas with less than 0.75D of regular corneal astigmatism. 5. Post-operative best corrected visual acuity projected to be 0.3 logMAR or lower. 6. Patient motivated for Intensity SL IOL after screening by surgeon. 7. Fundus visualization is possible. 8. Absence of retinal or optic nerve diseases

Exclusion criteria

Exclusion criteria: 1. Previous ocular or corneal surgery that may affect refraction accuracy or visual acuity 2. Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens 3. History or evidence of any ocular disease that may affect visual acuity 4. Rubella cataract 5. Amblyopia 6. Any other ocular condition that may predispose a subject to future complications or contraindicate implantation of the Intensity SL lens 7. Pupil abnormalities 8. Patients with pupil diameter greater than 4mm in photopic conditions 9. Pregnant, lactating, or planning to become pregnant during the course of the trial 10. Allergy or intolerance to required study medications 11. Subjects participating in a concurrent clinical trial or if they have participated in an ophthalmology clinical trial within the last 30 days 12. Traumatic cataracts

Design outcomes

Primary

Measure	Time frame
Visual AcuityTimepoint: 30th day, 90th day	—

Secondary

Measure	Time frame
Contrast Sensitivity Patient Satisfaction Defocus CurveTimepoint: 30th day, 90th day	—

Countries

India

Contacts

Public ContactProf A Heber

Dr. Agarwals Eye Hospital

drlionalraj@dragarwal.com09894067910

Outcome results

None listed

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