Comparison Of Two Preloaded IOL Delivery Systems, Alcon and HoyaVivinex® iSert® XY1 On Corneal Incision Configuratio

Phase 4

• Conditions: Health Condition 1: null- Cataract

• Registration Number: CTRI/2018/05/014036
• Lead Sponsor: AIIMS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br/ ><br>will be measured.Timepoint: Patients will be followed up on day 1, 1 month and 3 months post operatively.

Secondary Outcome Measures

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