H16 H17 H18 S05 T26 T81 T86
Conditions
Interventions
Group 1: Screening, Day 1 (first use of RETISSA), Home Phase without RETISSA, Control Visit A, Home Phase with RETISSA, Control Visit B, Follow-up Visit
Group 2: Screening, Day 1 (first use of RETISSA
Sponsors
QD Laser Deutschland GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Male or female outpatients, aged = 18 and = 85 years 2. Visually impaired according to legal definition (BCVA = 0.3) 3. Corneal opacities/diseases according to at least one of the following ICD-10 codes: • H16.- Keratitis • H17.- Corneal scars and opacities • H18.- Other disorders of the cornea • S05.- Injury of eye and orbit • T26.- Burn and corrosion confined to eye and adnexa • T81.- Complications of procedures • T86.0 - Bone-marrow transplant rejection 4. Best corrected visual acuity (BCVA) = 0.2 in the study eye 5. Difference between BCVA and VA assessed with retinometer =2 lines in the study eye 6. Ability to converse, read, and write fluently in German 7. Written informed consent 8. Subjects able and willing to attend all scheduled visits and comply with all study procedures and obligations
Exclusion criteria
Exclusion criteria: Eligible subjects must not meet any of the following exclusion criteria: 1. Significant function loss within the study eye due to diseases other than listed in inclusion criterion No. 3 or due to any surgery to the posterior part of the eye 2. Subject unable to tolerate the RETISSA eyewear 3. Intended corneal transplantation in the study eye in the next four months 4. Central or peripheral diseases of the vestibular system (e.g. Ménière´s Disease, vestibular migraine, benign paroxysmal positional vertigo, etc.) that cause a clinically significant vertigo 5. Previous application of pharmaceuticals with retinal toxicity, a. that have reached the cumulative doses in the patient or b. where treatment of the patient has not been stopped within the time frame of 5 half-lives (of the respective pharmaceutical) prior to the screening visit or c. for which treatment of the patient needs to be continued after screening 6. Diagnosed depression 7. Risk of non-compliance with study procedures (e.g. lack of cooperation) 8. Being immediate family of the investigator or trial staff, defined as the investigator's/staff's spouse, parent, child, grandparent, or grandchild 9. Conditions, which, in the opinion of the investigator, would not allow save participation in this study (drug addiction, alcohol abuse, etc.) 10. Females currently pregnant or breast-feeding 11. Participation in any study involving an investigational drug or device within the past 30 days or ongoing participation in a study with an investigational drug or device 12. Persons who are accommodated in an institution as a result of an official or judicial order
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To show an improvement of visual acuity by the laser eyewear system RETISSA in patients with visual impairment caused by corneal diseases | — |
Secondary
| Measure | Time frame |
|---|---|
| To show that there is no ocular damage induced by the laser eyewear after continuous usage, To show an improvement of vision-related quality of life by the laser eyewear, To show an improvement of the ability to perform tasks of daily living by the laser eyewear | — |
Countries
Germany
Contacts
Public ContactUlrike Kaiser
Klinik für Augenheilkunde des Universitätsklinikums Essen
Outcome results
None listed