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Long term Assessment of Vivinex® iSert® XY1 Lens - Posterior Capsule relation

Prospective Long term Evaluation of Intraocular Lens - Posterior Capsule Dynamics with Vivinex® iSert® XY1- Pilot Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/02/012151
Enrollment
100
Registered
2018-02-26
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: null- cataract

Interventions

Intervention1: Vivinex® iSert® XY1 intraocular lens: Newer generation hydrophobic acrylic aspheric IOL. Posterior surface is modified with ozone treatment.Smooth optic surface with textured rough ha

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age related 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

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 (immunosuppresion, diabetes mellitus, collagen vascular disease) 6. Patients with intraoperative complications like extended capsulorhexis, PCR 7. Patients not giving consent and patients not willing for follow up.

Design outcomes

Primary

MeasureTime frame
â?¢ Mean UCVA at 1 month â?¢ Lower and higher order abberations at each study visit day 1, 1 month and 3 months, 6 months and 1 yearTimepoint: â?¢ Mean UCVA at 1 month â?¢ Lower and higher order abberations at each study visit day 1, 1 month and 3 months, 6 months and 1 year

Secondary

MeasureTime frame
â?¢ Incidence of PCO at 1 year â?¢ IOL glistening at 1 year â?¢ Need for Yag Cap at 1 year Timepoint: â?¢ Incidence of PCO at 1 year â?¢ IOL glistening at 1 year â?¢ Need for Yag Cap at 1 year

Countries

India

Contacts

Public ContactDr Jeewan S Titiyal

AIIMS

titiyal@gmail.com9810649942

Outcome results

None listed

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