Clinical trial NCT04040790: Performance of Rigid Gas Permeable (RGP) Scleral Contact Lenses With a Passive Artificial Iris
Official title: Evaluation of Light Sensitivity and Visual Acuity Changes as Consequence of Rigid Gas Permeable (RGP) Scleral Contact Lenses With a Passive Artificial Iris
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Low Vision
Keywords: visual acuity
contrast sensitivity
scleral contact lens
artificial iris
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2019-08-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

- Age between 18 and 45 years old

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Visual acuity assessment and comparison between Designs A, B and C by means of logMAR or equivalent value
timeFrame: 5 months from fitting session
measure: Contrast sensitivity assessment and comparison between Designs A, B and C by means of threshold percentage or equivalent value
timeFrame: 5 months from fitting session
Secondary outcomes:
measure: Device safety by comparing eventual adverse events with those found in scleral contact lenses
timeFrame: 5 months from fitting session
measure: Correct fitting
timeFrame: 5 months from fitting session
measure: Contact lens wear comfort, as assessed by subject data from questionnaires Rasch analyzed using a 4-Andrich ration scale model
timeFrame: 5 months from fitting session
measure: Visual acuity assessment and comparison between Designs B (low contrast) and C (high contrast) by means of logMAR or equivalent value
timeFrame: 5 months from fitting session
measure: Contrast sensitivity assessment and comparison between Designs B (low contrast) and C (high contrast) by means of threshold percentage or equivalent value
timeFrame: 5 months from fitting session
measure: Horizontal visual angle
timeFrame: 5 months from fitting session
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent (UZGent)
Study officials:
affiliation: University Ghent
name: Andres F Vasquez Quintero, Professor
role: STUDY_CHAIR
References:
citation: Garcia-Lazaro S, Ferrer-Blasco T, Radhakrishnan H, Cervino A, Charman WN, Montes-Mico R. Visual function through 4 contact lens-based pinhole systems for presbyopia. J Cataract Refract Surg. 2012 May;38(5):858-65. doi: 10.1016/j.jcrs.2011.11.042. Epub 2012 Mar 16.
citation: Pepose JS. Small-aperture contact lenses for presbyopia. J Cataract Refract Surg. 2012 Nov;38(11):2060-1; author reply 2062-4. doi: 10.1016/j.jcrs.2012.08.041. No abstract available.
citation: Xu R, Gil D, Dibas M, Hare W, Bradley A. The Effect of Light Level and Small Pupils on Presbyopic Reading Performance. Invest Ophthalmol Vis Sci. 2016 Oct 1;57(13):5656-5664. doi: 10.1167/iovs.16-20008.
citation: Eyeson-Annan ML, Hirst LW, Battistutta D, Green A. Comparative pupil dilation using phenylephrine alone or in combination with tropicamide. Ophthalmology. 1998 Apr;105(4):726-32. doi: 10.1016/S0161-6420(98)94030-1.
citation: Compan V, Oliveira C, Aguilella-Arzo M, Molla S, Peixoto-de-Matos SC, Gonzalez-Meijome JM. Oxygen diffusion and edema with modern scleral rigid gas permeable contact lenses. Invest Ophthalmol Vis Sci. 2014 Sep 4;55(10):6421-9. doi: 10.1167/iovs.14-14038.
citation: Holden BA, Mertz GW. Critical oxygen levels to avoid corneal edema for daily and extended wear contact lenses. Invest Ophthalmol Vis Sci. 1984 Oct;25(10):1161-7.