First in Human Study of the LensOne Device for the Support of a Posterior Chamber Intraocular Lens in the absence of capsular and zonular support

Not Applicable

Recruiting

• Conditions: In need of an IOL, but without sufficient capsular support (e.g. aphakic, dislocated lens, dislocated IOL).; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12623000305628
• Lead Sponsor: ong Bridge Medial Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-03-17
• Last Update Posted: 4 July 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. In need of an IOL and without sufficient capsular support (e.g. aphakic, dislocated lens, dislocated IOL)
2. Ability to complete all required postoperative visits
3. White-to-white (WTW) of 11.0-13.0 mm as measured by optical biometry
4. Age: 50-85 years
5. Able to comprehend and provide informed consen

Exclusion Criteria

1. Corneal opacification precluding visualization of intraocular structures
2. Active retinal detachment or history of retinal detachment surgery within 12 months prior to Screening Visit
3. Active retinal vascular diseases
4. Active uveitis (infectious or non-infectious; anterior or posterior)
5. History of endophthalmitis
6. History of glaucoma filtering surgery
7. Need for concomitant glaucoma filtering surgery
8. Ciliary body cyst larger than 0.5 mm
9. Micro/nanophthalmos
10. Allergies to implant material, silicone
11. Active alcohol or narcotic dependence
12. Psychiatric illness preventing reliable follow up

Study & Design

• Study Type: Interventional
• Study Design: Not specified