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Presbyopia

Evaluation of Safety and Efficacy of Intrastromal Implantation of CorVision® Bioengineered Corneal Inlay for Correction of Presbyopia.

Sponsored by LinkoCare Life Sciences AB

About this trial

Last updated 2 years ago

Study ID

CMG-PRT-002-Rev6

Status

Active, not recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
40 to 65 Years
All
All

Trial Timing

Ended 2 years ago

What is this trial about?

This clinical investigation is a prospective, multicentre, non-comparative case series to assess safety and efficacy of CorVision® bioengineered corneal inlay for improving uncorrected near vision in presbyopic subjects. In this study a sterile medical grade collagen-based bioengineered corneal inlay (CorVision®), which closely mimics the human corneal tissue, will be tested as a natural microlens for correction of near vision in presbyopic patients. The primary endpoint for this study is to further determine the safety of the inlay and the secondary endpoint is to determine the efficacy of the inlay to improve uncorrected near vision. CorVision® implantation will be done via a minimally invasive laser-assisted intra-stromal surgery. Besides important information concerning details of the surgical method and postoperative care, tolerance of the device and possible adverse events will be reported along with several clinical parameters to be measured preoperatively and postoperatively. The study will consist of 110 subjects receiving the inlay to be included within a recruitment period of 18 months at multiple clinical sites. All subjects will be followed for minimum 12-months postoperatively. Postoperative evaluations are scheduled at 1 week, 1, 3, 6, and 12 months.

What are the participation requirements?

Yes

Inclusion Criteria

- Signed and dated informed consent

- Presbyopic adults, Male or female between 40-65 years of age who need from +1.25 D to +3.50 D of reading addition in the non- dominant eye to improve near visual acuity by at least one line or more.

- Manifest refraction spherical equivalent (MRSE) between -0.75 and +1.50 D with ≤1.5 D of refractive cylinder in the non-dominant eye.

- Stable refraction, i.e. MSRE within 0.50 D over prior 12 months in the non-dominant eye.

- Corrected distance visual acuity CDVA ≥ 0.7 in the dominant and non-dominant eye

No

Exclusion Criteria

- Anterior segment pathology in the non-dominant eye.

- Signs or symptoms of clinically significant cataracts in the non-dominant eye.

- Residual, recurrent, active ocular or uncontrolled eyelid disease, or any corneal abnormality (including endothelial dystrophy, recurrent corneal erosion, etc.) in the nondominant eye.

- Visually significant macular pathology

- Central corneal thickness <470 microns in either eye and corneal curvature ≥ 50D

- Corneal ectasia, keratoconus or form frust keratoconus

- Clinically significant dry eye disease

- Any prior ocular surgery in the non-dominant eye.

- History of herpes zoster or herpes simplex keratitis in the non-dominant eye.

- Inability of patient to understand the study procedures and thus inability to give informed consent.

- Participation in another clinical study within the last 3 months

- Already included once in this study (can only be included for one treated eye).

- General history judged by the investigator to be incompatible with the study (e.g., life-

- threatening patient condition, other condition where postoperative follow-up may be difficult).

- known uncontrolled diabetes or other neuro-degenerative disorder (as corneal nerves can be affected leading to impaired wound healing)

Locations

Location

Status