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NCT07859917
Study in Young Adults to Understand How Glasses With a Small Reading Addition Affect Focusing and Eye Coordination During Vision Tasks
Conditions: Healthy Young Adults, Accommodation Disorder
Sex: All
Ages: 18 Years – 35 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 96
Sponsor: Essilor International
Location: City St Georges's, University of London London
Summary
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
Inclusion Criteria:
* 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
* 5.Distance refractive error (Sphere) within the range of \[-6.00D to +3.00D\] (with cylinder in the negative form)
* 6.Cylindrical component of the refractive error within the range of \[0 to -2 D\] in both eyes
* 7.Anisometropia within the range of \[0.00D to +1.50D\]
* 8.A visual acuity with new prescription at distance and at near greater or equal to 20/25 (6/7.5, 0.1 logMAR) monocularly and binocularly
* 9.No visual acuity difference inferior or equal to 0.1 logMAR between right and left eye at distance and at near
* 10.Phakic eyes
* 11.Daily activities of the participant mostly in near vision (at least 6 hours during weekday)
Exclusion Criteria:
* 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
* 5.Persons wearing or that have previously worn any type of anti-fatigue or lenses with a boost
* 6.Persons who don't wear glasses
* 7.Severe ocular pathology declared, involving a loss of visual field as in glaucoma or involving a loss of acuity and strong discomfort in environments with little or too much light as in retinitis pigmentosa or moderate or severe dry eye diagnosed.
* 8.Reported neurological deficit, including a history of epilepsy or sensorimotor coordination disorders, vestibular or cerebellar pathology (e.g., balance disorders, dizziness)
* 9.Overt aphakic or pseudophakic (intraocular implant)
* 10.Constant or intermittent diplopia or double vision with a +1.00D lens at near
* 11.Ocular diseases nor general pathologies with an impact on visual field or vision.
* 12.Reported systemic condition, medical treatment or medication that affects vision
* 13.Manifest or decompensating latent strabismus, amblyopia, nystagmus.
* 14.Known contraindication to cyclopentolate 1% or its excipients
* 15.Known risk of angle-closure glaucoma.
Source: ClinicalTrials.gov (NCT07859917). StuddyBuddy aggregates publicly available trial information.