Status:
TERMINATED
Performance of Rigid Gas Permeable (RGP) Scleral Contact Lenses With a Passive Artificial Iris
Lead Sponsor:
University Ghent
Conditions:
Low Vision
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
Data from 15 healthy subjects will be recorded in two testing sessions spread on two days, using three lens designs (A, B and C). Before the measuring days, each subject will undergo an extra fitting ...
Detailed Description
First, the participant will be subjected to an RGP scleral contact lens fitting session, then during the second and third visits the participant will be subjected to several non-invasive procedures sp...
Eligibility Criteria
Inclusion
- \- Age between 18 and 45 years old
Exclusion
- Iris disorders (i.e. ocular albinism, coloboma, aniridia).
- Known disease-related ocular surface problem (i.e. microbial keratitis).
- Known ocular pathologies (except refractive disorders).
- Coexistent ocular diseases impeding contact lens correction (i.e. glaucoma, previous ocular surgery).
- Corneal scarring.
- Low corneal endothelial cell count (\< 1500 cells per mm2), with potential of corneal hypoxia-induced corneal edema induced by contact lens wear.
- Wearing of contact lenses in the last 24 hours (prior to the interventions).
Key Trial Info
Start Date :
September 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04040790
Start Date
September 16 2019
End Date
June 22 2021
Last Update
April 27 2022
Active Locations (1)
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1
University Hospital Ghent (UZGent)
Ghent, Belgium, 9000