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Comparative assessment of visual functions of Monofocal Intra-Ocular Lens (IOL) with TECNIS EYHANCE Refractive IOL

Assessment of Visual Quality and Stereopsis of a Next Generation Monofocal Intra-Ocular Lens with Innovative Anterior Refractive Surface (TECNIS EYHANCE Refractive IOL ICB00)

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/031367
Enrollment
40
Registered
2021-02-17
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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: Assessment of Visual Quality and Stereopsis of a Next Generation Monofocal Intra-Ocular Lens with Innovative Anterior Refractive Surface (TECNIS EYHANCE Refractive IOL ICB00): Type of s
Double Blinded Randomized Comparative Study. Place of Recruitment: Outpatient Department, Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi. Sample Size: 40 consecutive patients atte
Double Blinded Randomized Comparative Study. Place of Recruitment: Outpatient Department, Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi. Sample Size: 40 consecutive patients atte

Sponsors

Dr Rajendra Prasad Centre for Ophthalmic Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria 1. Age related bilateral senile cataract 2. Best Corrected Visual Acuity (BCVA) > 5/60 3. Age 45 â?? 75 years 4. Axial length 22 â?? 24.5mm 5. No ocular / systemic contraindication for surgery 6. A patient with preoperative corneal astigmatism less than 1D in each eye 7. A patient with clear ocular media other than cataract in each eye 8. A patient with normal OCT of the macula in each eye 9. A patient with pharmacological pupil dilation of > 6 mm in each eye 10. A patient must be able to read, comprehend, and be willing to give HIPAA and informed consent in English.

Exclusion criteria

Exclusion criteria: Exclusion criteria 1. Mature senile cataract or nuclear sclerosis advanced enough to obscure fundus details 2. Posterior segment pathology (glaucoma, age-related macular degeneration, diabetic retinopathy) 3. Complicated cataract 4. Irregular corneal astigmatism (keratoconus, scars, pellucid marginal degeneration) 5. Systemic conditions (immunosuppression, diabetes mellitus, collagen vascular disease) 6. Patients with intraoperative complications like extended capsulorhexis, PCR 7. Patients with known endothelial dysfunction 8. Patients not giving consent and patients not willing for follow up.

Design outcomes

Primary

MeasureTime frame
Primary Objectives: 1. Visual acuity (Near, intermediate and distance) 2. Visual Quality (MTF, PSF, HOA, Glare, Halos) 3. Near and distance stereopsis Timepoint: Visit Schedule 1. Preoperative visit 2. Operative visit 3. Postoperative visit 1 (Day 1) 4. Postoperative visit 2 (1 month) 5. Postoperative visit 3 (3 months) 6. Postoperative visit 4 (6 months)—

Secondary

MeasureTime frame
Secondary Objective: 1. To evaluate post-operative anatomical outcomes and posterior capsular opacification at 6 months 2. To evaluate post-operative astigmatism at 6 months 3. To evaluate post-operative Quality-of-vision and spectacle-dependence questionnaires at 6 months (NEI-VFQ 25 Questionnaire) Timepoint: Visit Schedule 1. Preoperative visit 2. Operative visit 3. Postoperative visit 1 (Day 1) 4. Postoperative visit 2 (1 month) 5. Postoperative visit 3 (3 months) 6. Postoperative visit 4 (6 months)—

Countries

India

Contacts

Public ContactJeewan S Titiyal

Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS

titiyal@gmail.com9810649942

Outcome results

None listed

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