None listed
Conditions
Brief summary
The purpose of the study is to demonstrate the safety and efficacy of the LensOne device, which allows surgeons to implant a single piece, posterior chamber IOL in patients with aphakia. It is hypothesized that the LensOne device can provide surgeons and patients a safe and stable solution for fixating a posterior chamber IOL when there is insufficient capsular and zonular support. This study aims to establish the safety of the LensOne device and to provide surgeons with a consensus method of securing a posterior chamber IOl when there is insufficient capsular or zonular support.
Interventions
The study population includes subjects who would benefit from the implantation of an intraocular lens (IOL) and are not suitable for a posterior chamber IOL because of insufficient capsular and zonular support.
The LensOne is a sterile, non-optical ocular implant that is permanently inserted into the
posterior chamber of the eye during intraocular surgery. The device is intended to provide stable support for a posterior chamber intraocular lens in eyes that lack capsular and zonular support.
The study population includes subjects who would benefit from the implantation of an intraocular lens (IOL) and are not suitable for a posterior chamber IOL because of insufficient capsular and zonular support. The LensOne is a sterile, non-optical ocular implant that is permanently inserted into the posterior chamber of the eye during intraocular surgery. The device is intended to provide stable support for a posterior chamber intraocular lens in eyes that lack capsular and zonular support. LensOne is suspended in the eye by three fixation arms which are trans-scleraly and subconjunctivally anchored. It has an internal cavity called the IOL housing designed to interact with the haptics of an IOL and securely envelope the IOL. The LensOne device will be implanted during day surgery by a vitreoretinal surgeon after a screening visit. The surgery is expected to take approximately one hour and participants will be assessed post-operatively at 6 visits over 12 months.
Sponsors
Long Bridge Medial Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Healthy volunteers
No
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
Outcome results
None listed