NCT04040790

Performance of Rigid Gas Permeable (RGP) Scleral Contact Lenses With a Passive Artificial Iris

Evaluation of Light Sensitivity and Visual Acuity Changes as Consequence of Rigid Gas Permeable (RGP) Scleral Contact Lenses With a Passive Artificial Iris

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University Ghent · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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 session of a large-diameter scleral contact lens on the dominant eye, assessed by an experienced practitioner. The fitting data will be used to custom-make the three lens designs for each subject, thus ensuring their comfort and safety during the days of the experiments. During the experiment days baseline measurements will be obtained before and after pupil dilation and contact lens wear. During the first testing session data from the lens design A (reference lens without artificial iris) will be recorded. During the second testing session data from the lens designs B and C (lenses with artificial iris with different transmittances) will be recorded. In each testing session, contrast sensitivity and visual acuity will be evaluated and non-invasive imaging measurements will be undertaken (optical coherence tomography and slit lamp). A specific questionnaire will be given to the subject to assess comfort, light sensitivity, the horizontal visual angle and overall experience of the scleral lens and in combination with a pair of sunglasses category 3-4.

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 specific to the study in order to assess contrast sensitivity and visual acuity using the fitted and uniquely fabricated investigational medical devices. The tests will be performed after eye drops are supplied to dilate the pupil of the subjects (eye drops: tropicamide and phenylephrine). Besides the clinical experiments, the participant will be given a specific questionnaire in order to assess comfort, light sensitivity, horizontal visual angle and overall experience of the investigational medical device and in combination with a pair of sunglasses category 3-4. The investigators will document the occurrence of any adverse events and specific side effects during Day 2 and 3 (testing sessions with the investigational devices) in order to effectively assess their safety.

Conditions

• Low Vision

Interventions

Type	Name	Description
DEVICE	Scleral contact lens without a passive artificial iris	Participants wear a scleral contact lens without a passive artificial iris (Design A) on the dominant eye to perform the baseline visual performance assessment
DEVICE	Scleral contact lens with a passive artificial iris with low contrast (<1:5)	Participants wear a scleral contact lens with a low contrast (\<1:5) passive artificial iris (Design B) on the dominant eye to perform the baseline visual performance assessment
DEVICE	Scleral contact lens with a passive artificial iris with high contrast (>1:5)	Participants wear a scleral contact lens with a low contrast (\<1:5) passive artificial iris (Design B) on the dominant eye to perform the baseline visual performance assessment
DRUG	Tropicamide and phenylephrine	Participants receive pupil dilation eye drops on the dominant eye, after baseline measurement and before wearing the scleral contact lenses (Designs A, B and C)

Timeline

• Start date: 2019-09-16
• Primary completion: 2021-06-22
• Completion: 2021-06-22
• First posted: 2019-08-01
• Last updated: 2022-04-27

Locations

1 site across 1 country: Belgium