Study in Young Adults to Understand How Glasses With a Small Reading Addition Affect Focusing and Eye Coordination During Vision Tasks

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorEssilor International

About this trial

This clinical study aims to understand how glasses with a small reading addition affect the way the eyes focus and work together in young adults with normal near vision.

Some people experience focusing difficulties or visual discomfort during near-vision activities such as reading or using digital devices. This study will evaluate whether glasses with a small reading addition can help reduce these difficulties and improve visual comfort.

Researchers will compare two different pairs of glasses designed to provide additional support for near vision. They will assess how each pair affects eye focusing and eye coordination using standard optometric examinations.

Participants will:

* Wear three pairs of glasses, each for approximately 4 weeks. * Complete eye examinations to evaluate focusing ability and eye coordination. * Answer questionnaires about visual comfort, eye strain, and overall quality of vision.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

1.Voluntary person, fluent in English willing to follow the protocol, able to read and understand the information form and give his free and informed consent

2.Aged between 18 and 35 years old

3.Non-presbyopic

4.Wears glasses for at least 6 hours per day

Disqualifiers

1.Pregnant woman or nursing

2.Persons deprived of their liberty by a judicial or administrative decision and persons hospitalized without consent and persons admitted to a health or social institution for purposes other than research

3.Adults who are unwilling or unable to express consent

4.Participant in exclusion period from another study

Trial design

Design model

Crossover

Treatments tested in this trial

  • Eye exam

    Device

    An optometric eye exam

  • Questionnaires

    Other intervention

    Questionnaires on the eye fatigue and the quality of vision

  • Washout lenses

    Device

    Standard single-vision spectacle lenses prescribed according to each participant's refractive error and worn during the washout period before allocation to the study lenses.

  • Reference lenses

    Device

    Spectacles lenses optimized near vision lenses for the comparator

  • Test lenses

    Device

    Spectacles lenses optimized near vision lenses for the test

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: 1st worn pair of glasses : Reference / 2nd worn pair of glasses : TestExperimental treatment 5 interventions
Group B: 1st worn pair of glasses : Test / 2nd worn pair of glasses : ReferenceExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Accommodative facility difference

Measurement of the accommodative facility to understand the flexibility of the accommodation. It will be measured in cycle per minute (cpm) using a +/-2.00D flipper lens test at 40cm according to standard clinical accommodative facility testing procedures. Lenses are placed in front of the eyes to stimulated or not the accommodation on a text. The main goal of the participant is to keep clear and single the target while switching between the accommodative lenses and the non accommodative lenses. The results obtained after the wearing period of each lenses will be compared together.

Time frame
From enrollement to the end of the participation at about 16 weeks

Secondary outcomes

1

Visual fatigue questionnaire score

Visual fatigue assessed using a validated questionnaire, CISS (Borsting et al, Optometry and Vision Science. 2003, 80(12):832-838). Total questionnaire scores (range 0 to 56 with a higher score meaning a higher fatigue) obtained after each lens-wear period will be compared between the reference lens and the test lens

Time frame
From enrollement to the end of the participation at about 16 weeks
2

Visual Comfort Questionnaire Score

Visual comfort assessed using a questionnaire administered at the end of each lens-wear period. Questionnaire scores (range from 0 to 182) will be compared between the reference lens and the test lens.

Time frame
From enrollement to the end of the participation at about 16 weeks
3

Vision Quality Questionnaire Score

Subjective quality of vision assessed using a questionnaire. Total questionnaire scores (range from 0 t o182) will be compared between the reference lens and the test lens.

Time frame
From enrollement to the end of the participation at about 16 weeks
4

Participant Lens Preference

Participant preference for the reference lens or the test lens assessed at the completion of both lens-wear periods using a preference questionnaire.

Time frame
From enrollement to the end of the participation at about 16 weeks

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: