Comparison Of Two Preloaded IOL Delivery Systems, Alcon and Hoya VivinexÂ® iSertÂ® XY1 On Corneal Incision Configuration

Prospective Comparative Evaluation Of Two Preloaded IOL Delivery Systems, Alcon and Hoya VivinexÂ® iSertÂ® XY1 On Clear Corneal Incision Configuration â?? A Pilot Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/05/014036

Enrollment

Registered

2018-05-22

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: IOL implantation with the Ultraert and VivinexÂ® iSertÂ® XY1 systems .: group will undergo conventional phacoemulsification using CENTURIONÂ® Vision System (Fort Worth, Texas, USA) and

Eligibility

Inclusion criteria

Inclusion criteria: Age related senile cataract Axial length 22-24.5mm No ocular or systemic contraindications for surgery Patient willing to give consent

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

Measure	Time frame
Clear corneal incision,width of the incision and the length of the tunnel would be measured. Morphology (biplanar/ triplanar) will be assessed using the iOCT. Changes in the wound during various stages of surgery, presence of wound site descemetâ??s membrane detachment (DMD) would be looked for and the stage at which it occurred would be noted. The surgery will be recorded and the intraoperative dimensions of the incision will be measured.Timepoint: Patients will be followed up on day 1, 1 month and 3 months post operatively.	—

Measure

Time frame

Clear corneal incision,width of the incision and the length of the tunnel would be measured. Morphology (biplanar/ triplanar) will be assessed using the iOCT. Changes in the wound during various stages of surgery, presence of wound site descemetâ??s membrane detachment (DMD) would be looked for and the stage at which it occurred would be noted. The surgery will be recorded and the intraoperative dimensions of the incision will be measured.Timepoint: Patients will be followed up on day 1, 1 month and 3 months post operatively.

—

Secondary

Measure	Time frame
Post-operative anatomical outcomes, astigmatism, post-operative higher order aberrations, ease of IOL insertion and complications associated with IOL injection.Timepoint: Patients will be followed up on day 1, 1 month and 3 months post operatively.	—

Countries

India

Contacts

Public ContactDr Jeewan S Titiyal

Dr Rajendr Prasad Centre for Ophthalmic Sciences,AIIMS, New Delhi

titiyal@gmail.com9810649942

Outcome results

None listed

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