study to assess use of laser for cataract surgery in cataracts of late stage (Intumescent cataracts)

Phase 4

• Conditions: Health Condition 1: null- With an intumescent cataracteligible for cataract surgery

• Registration Number: CTRI/2015/12/006464
• Lead Sponsor: Alcon laboratories India pvt Ltd

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: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 425

Inclusion Criteria

1. Adults, 21 years of age or older who are willing to undergo cataract surgery

2. Able to lie flat in a supine position

3. Able to understand and sign the Informed Consent Form (ICF)

4. Subjects must present with intumescent white cataract, with a liquid pressurized bag

and a milky, liquid cortex

Exclusion Criteria

1. Subjects who refuse to sign the informed consent

2. Pregnant or lactating mothers

3. Corneal disease that precludes application of the cornea or transmission of laser light

at 1030 nanometer (nm)wavelength

4. Descemetocele with impending corneal rupture

5. Corneal opacity that would interfere with the laser beam

6. Presence of blood or other material in the anterior chamber

7. Hypotony or presence of corneal implant

8. Poorly dilating pupils, such that the iris is not peripheral to the intended diameter for

the capsulotomy

9. Condition which would cause inadequate clearance between the intended capsulotomy

depth and the endothelium

10. Residual, recurrent, active ocular or eye lid disease, including any corneal abnormality

(for example, recurrent corneal erosion, severe basement membrane disease)

11. A history of lens or zonular instability

12. Any contraindication to cataract surgery

13. Corneal thickness requirements that are beyond the range of the LenSx Laser system

(More than 1200 μ)

14. Subjects who in the opinion of the investigator are not good candidates for the trial

15. Subjects whose postoperative best corrected visual potential is expected to be worse

than 20/40 Snellen (0.3 logMAR) at the final study visit

Study & Design

• Study Type: Interventional
• Study Design: Not specified