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

NCT04465409 | Active Not Recruiting DMC

• 1 other identifier: CMG-PRT-002-Rev6
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Presbyopia

Keywords

presbyopia; bioengineered corneal inlay; femto second laser; intrastromal implantation; biocompatible; medical device; sterile; medical grade; natural; refractive error

Outcome Measures

Primary Outcomes (2)

• Safety outcome

  The primary safety endpoint is defined such that a rejection leading to implant removal should occur in no more than 3% of implanted eyes. The implant rejection is defined as a clinical situation when the implanted eye has decreased central corneal clarity and decreased implant clarity, corneal vascularization inside of laser created pocket and inflammation.

  6 months

• Efficacy outcome

  The primary efficacy endpoint is that more than 65% of the eyes should have an uncorrected near visual acuity (UNVA) of 0.3 logMAR or better at 6 months postoperatively.

  6 months

Study Arms (1)

Presbyopic adults

EXPERIMENTAL

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. In this investigation, CorVision® will be implanted in the non-dominant eye to improve near vision and the dominant eye is left intact or corrected by a standard refractive surgery to emmetropia. In brief, subjects will undergo laser corneal surgery on their non-dominant eye to create an anterior stromal pocket into which the investigational device will be implanted.

Device: Intrastromal implantation of CorVision bioengineered corneal inlay for correction of presbyopia.

Interventions

Intrastromal implantation of CorVision bioengineered corneal inlay for correction of presbyopia. DEVICE

Presbyopia is an age-related progressive loss of crystalline lens accommodation power resulting in the decreased ability to see near objects. CorVision® is a tissue-mimetic device primarily intended to be used as a corneal inlay in the management of presbyopia and low hypermetropia. The inlay is inserted into the patient's cornea via a minimally invasive laser pocket procedure to modify corneal surface topography and corneal optical performance.

Presbyopic adults

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• LinkoCare Life Sciences AB: lead

Study Sites (1)

Gemini Eye Clinics

Zlín, 760 01, Czechia

Location

MeSH Terms

Conditions

Presbyopia; Infertility; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases; Genital Diseases; Urogenital Diseases

Study Officials

• Katerina Klimesova, MD

  Gemini Eye Clinics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 10, 2020
• Study Start: March 25, 2020
• Primary Completion: September 25, 2022
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-09

Locations

CZ (1)