Status:
ACTIVE_NOT_RECRUITING
Evaluation of Safety and Efficacy of Intrastromal Implantation of CorVision® Bioengineered Corneal Inlay for Correction of Presbyopia.
Lead Sponsor:
LinkoCare Life Sciences AB
Conditions:
Presbyopia
Eligibility:
All Genders
40-65 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Upon signing of informed consent and study inclusion, both eyes will be screened to determine which eye is dominant and to ensure that the non-dominant eye meets the visual acuity, refraction, and oth...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
March 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2026
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04465409
Start Date
March 25 2020
End Date
June 30 2026
Last Update
September 3 2025
Active Locations (1)
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1
Gemini Eye Clinics
Zlín, Czechia, 760 01