An open label, prospective, randomized, crossover, monocentric clinical trial to assess safety and performance of a retinal imaging laser eyewear system in patients with visual impairment caused by corneal diseases.
- Conditions
- S05T26T81T86KeratitisH16H17H18Corneal scars and opacitiesOther disorders of cornea
- Registration Number
- DRKS00016583
- Lead Sponsor
- QD Laser Deutschland GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 21
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To show an improvement of visual acuity by the laser eyewear system RETISSA in patients with visual impairment caused by corneal diseases
- Secondary Outcome Measures
Name Time Method 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