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

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.

Conditions

• Low Vision

Interventions

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)

Sponsors & Collaborators

• University Ghent

  lead OTHER

Principal Investigators

• Andres F Vasquez Quintero, Professor · University Ghent

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-09-16

Primary Completion

2021-06-22

Completion

2021-06-22

Countries

• Belgium

Study Locations