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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-16

Study Completion Date

2021-06-22

Brief Summary

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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.

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Detailed Description

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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

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Low Vision

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Healthy volunteers

15 healthy volunteers for trials with passive artificial iris

Group Type EXPERIMENTAL

Scleral contact lens without a passive artificial iris

Intervention Type DEVICE

Participants wear a scleral contact lens without a passive artificial iris (Design A) on the dominant eye to perform the baseline visual performance assessment

Scleral contact lens with a passive artificial iris with low contrast (<1:5)

Intervention Type DEVICE

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

Scleral contact lens with a passive artificial iris with high contrast (>1:5)

Intervention Type DEVICE

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

Tropicamide and phenylephrine

Intervention Type DRUG

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)

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type DEVICE

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)

Intervention Type DRUG

Other Intervention Names

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Control lens Design A Test lens Design B Pupil dilation eye drops

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes