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A study comparing vision clarity and daily visual comfort after cataract surgery using two types of trifocal eye lenses

Comparison of visual performance and quality of vision between two trifocal intraocular lenses randomized clinical trial - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097387
Enrollment
50
Registered
2025-11-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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: BVI PhysIOL Trifocal Intraocular Lens implantation : Patients undergoing phacoemulsification for age-related cataract will receive BVI PhysIOL trifocal intraocular lens implantation. Su

Sponsors

Prashant Tomar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged greater than 18 years with age-related cataract. 2. Willing for trifocal intraocular lens implantation. 3. Desire for spectacle independence at all distances. 4. Willing to participate in the study and provide written informed consent. 5. Able to comply with postoperative follow-up schedule.

Exclusion criteria

Exclusion criteria: 1. History of previous ocular surgery or trauma. 2. Presence of ocular comorbidities such as glaucoma, diabetic retinopathy, or macular degeneration. 3. Irregular corneal astigmatism or keratoconus. 4. Corneal opacity or any other condition affecting visualization of intraocular structures. 5. Systemic diseases that may affect vision or healing, such as uncontrolled diabetes mellitus or multiple sclerosis. 6. Intraoperative complications such as posterior capsular rupture or zonular weakness. 7. Psychiatric illness or cognitive impairment that affects the ability to complete subjective questionnaires. 8. Patients with unrealistic expectations regarding postoperative visual outcomes.

Design outcomes

Primary

MeasureTime frame
Uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA at 60–80 cm), and uncorrected near visual acuity (UNVA at 40 cm) after implantation of BVI PhysIOL and Tecnis Synergy trifocal intraocular lenses. Timepoint: Uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA at 60–80 cm), and uncorrected near visual acuity (UNVA at 40 cm) after implantation of BVI PhysIOL and Tecnis Synergy trifocal intraocular lenses.

Secondary

MeasureTime frame
1. Assessment of glare & halos using NEI near vision subscale — at 4 weeks postoperatively. 2. Quality of vision assessment using Rasch-scored Quality of Vision questionnaire — at 4 weeks postoperatively. 3. Patient satisfaction with visual performance — at 4 weeks postoperatively. Timepoint: 4 weeks postoperatively

Countries

India

Contacts

Public ContactSantosh Kumar

Command Hospital Eastern Command

Santo21051977@gmail.com9602906343

Outcome results

None listed

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