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Soft Contact Lenses

Contact Lenses for Near-sightedness

N/A

Recruiting

Led By Langis Michaud, OD MS

Research Sponsored by Université de Montréal

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged between 18 and 35

Be between 18 and 65 years old

Must not have

Recent intake (< 3 months) of medication affecting blood pressure (e.g. hypotensive, anovulant, CNS stimulant, etc.)

Corneal dystrophy or irregularity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measurement done at baseline and after 1 week of contact lens wear

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study how a special type of contact lens affects the blood flow in the eye and the thickness of a specific part of the eye in young adults with nearsightedness. The study

Who is the study for?

This trial is for healthy young adults aged 18-35 with mild to moderate near-sightedness (myopia between -1.00D and -4.00D). Participants must be willing to wear two types of soft contact lenses, each for one week, and undergo eye scans.

What is being tested?

The study tests if a myopic defocus soft lens design (MDSL) affects retinal blood flow and choroidal thickness compared to standard single vision lenses (SVSL). It includes wearing both lens types, eye scanning with OCT technology, and completing comfort questionnaires.

What are the potential side effects?

Potential side effects are not specified but may include discomfort or irritation from wearing the contact lenses, as well as possible visual disturbances due to the defocus design of the MDSL.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 35 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have taken medication that affects blood pressure in the last 3 months.

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I have a corneal condition affecting my eye's surface.

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I use eye drops or ointments for my eyes.

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I have had surgery to correct my vision.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measurement done at baseline and after 1 week of contact lens wear

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measurement done at baseline and after 1 week of contact lens wear

This trial's timeline: 3 weeks for screening, Varies for treatment, and measurement done at baseline and after 1 week of contact lens wear for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measurement of Retinal blood vessel density measured by Triton OCT-A

Other study objectives

Evaluation of the choroidal thickness at the macular area

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Myopic defocus soft lens design (MDSL)Experimental Treatment1 Intervention

This arm involves the wear of a daily disposable soft contact lens (nesofilcon A) designed with a myopic defocus zone. This is a 14.2mm total diameter lens with a 4.2mm central zone for distance vision correction. This is followed by an abrupt transition zone of 1.2mm with no optical power. Then a higher convex power zone covers the surface to the edge of the optical zone (8mm). The rest of the lens (up to 14.2 mmOAD) supports the lens on the eye surface and has no power nor refractive effect. The power of the add area is calibrated to the central power to achieve a net add power of +5D. For example: -1.00D central power is surrounded by a +6D convex area; -2D is surrounded by a +7D area, and so on.)

Group II: Single vision soft lens design (SVSL)Active Control1 Intervention

This arm involves the wear of a daily disposable soft contact lens (nesofilcon A) designed as a regular optical device to compensate for refractive error. In the case of this study, this lens will be made available from -1.00D to -4.00D. This lens is already in regular use in the US (K113703) and Canadian markets. Its design includes a central optical zone of 8mm that is powered to correct distance vision. The rest of the lens is supported on the ocular surface and has no power.

0 / 5Eligibility criteria met