To study the visual outcome after the implantation of an intraocular lens with three focal points in both eyes undergoing cataract surgery.

Clinical And visual outcomes following bilateral implantation of trifocal intraocular lenses with asymmetric light distribution. - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/066989

Enrollment

Registered

2024-05-08

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

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

Conditions

Health Condition 1: H250- Age-related incipient cataract

Interventions

Intervention1: Surgical intervention in cataract patients: Bilateral implantation of trifocal intraocular lenses with asymmetric light distribution Intervention2: Surgical intervention: bilateral impl

Eligibility

Inclusion criteria

Inclusion criteria: Bilateral implantation (second eye surgery within two weeks from the first eye surgery. Age more than 21 Years Cataractous eyes with no comorbidity Regular corneal topography and corneal astigmatism Patient desiring spectacle independence and having realistic expectations. Availability, willingness and sufficient cognitive awareness to comply with examination procedures Signed informed consent

Exclusion criteria

Exclusion criteria: Active ocular disease in the operative eye Subjects with any systemic disease that could increase operative risk or confound the outcome Pregnant or lactating or planning a pregnancy at the time of enrolment Any patient who is taking part in another study involving ocular surgery Significant irregular corneal astigmatism- Keratoconus/ post refractive surgery/ post LASIK ectasia Pupil abnormalities

Design outcomes

Primary

Measure	Time frame
Monocular Uncorrected Distance Visual Acuity(UDVA) and Best Corrected Distance Visual Acuity (CDVA) using ETDRS chart at 4 meters Monocular and Binocular Uncorrected(UIVA)and distance corrected Intermediate Visual Acuity (DCIVA) using ETDRS charts at 40, 66 and 80 cm Manifest refraction (Sphere, Cylinder, Spherical Equivalent) Binocular Uncorrected near (UNVA) and distance corrected near visual Acuity (DCIVA) using ETDRS charts. Timepoint: Post op day 1, 2 weeks, 3 Months Follow-up	—

Measure

Time frame

Monocular Uncorrected Distance Visual Acuity(UDVA) and Best Corrected Distance Visual Acuity (CDVA) using ETDRS chart at 4 meters Monocular and Binocular Uncorrected(UIVA)and distance corrected Intermediate Visual Acuity (DCIVA) using ETDRS charts at 40, 66 and 80 cm Manifest refraction (Sphere, Cylinder, Spherical Equivalent) Binocular Uncorrected near (UNVA) and distance corrected near visual Acuity (DCIVA) using ETDRS charts. Timepoint: Post op day 1, 2 weeks, 3 Months Follow-up

—

Secondary

Measure	Time frame
Binocular corrected defocus curve using defocusing lenses of -3.0D to +3D Reading Speeds using Salzburg Reading Desk at preferred reading and intermediate distance iTrace undilated. HDA (Objective scatter index and Modulated transfer function) Mesopic Contrast Sensitivity (FACT CSV) Photic phenomenon by dysphotopsia questionnaire ( post op 3 months followup) Patient satisfaction, spectacle independence and quality of vision (QOV) questionnaire ( post op 3 months followup) Any significant adverse events intra-operatively or post-operatively at any time point, will be reported to the institutional ethics committee within a period of 48 hours. Timepoint: 2 weeks, 3 Months Follow-up	—

Measure

Time frame

Binocular corrected defocus curve using defocusing lenses of -3.0D to +3D Reading Speeds using Salzburg Reading Desk at preferred reading and intermediate distance iTrace undilated. HDA (Objective scatter index and Modulated transfer function) Mesopic Contrast Sensitivity (FACT CSV) Photic phenomenon by dysphotopsia questionnaire ( post op 3 months followup) Patient satisfaction, spectacle independence and quality of vision (QOV) questionnaire ( post op 3 months followup) Any significant adverse events intra-operatively or post-operatively at any time point, will be reported to the institutional ethics committee within a period of 48 hours. Timepoint: 2 weeks, 3 Months Follow-up

—

Countries

India

Contacts

Public ContactPriyanka

Nethradhama Superspeciality Eye Hospital

riddhivora99@gmail.com9892909009

Outcome results

None listed

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