Objective and Subjective Evaluation of Ophthalmic Lenses With Extra Power
NCT ID: NCT05089240
Last Updated: 2021-10-22
Study Results
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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COMPLETED
NA
127 participants
INTERVENTIONAL
2016-06-06
2017-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
DOUBLE
Study Groups
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20-29 years (+0.40D extra power)
Ophthalmic lens with extra power
30-35 years (+0.40D extra power)
Ophthalmic lens with extra power
20-29 years (+0.40D extra power with blue cut)
Ophthalmic lens with extra power
Interventions
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Ophthalmic lens with extra power
Eligibility Criteria
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Inclusion Criteria
* Non-presbyopes
* Permanent wearers who wear glasses for at least 5 hours a day
* Distance refractive error within the range of \[+6.00 to -6.00\]\* (with cylinder in the negative form),
* Cylindrical component of the refractive error within the range of 0 to 2 D in both eyes,
* Anisometropia ≤ 1.00 D in sperical equivalent,
* Visual acuity of +0.10 logMAR or better in each eye with new prescription at distance (high contrast/high luminance),
* Distance visual acuity difference ≤0.20 logMAR between right and left eye (high contrast, high luminance)
* Near binocular visual acuity of +0.10 logMAR or better with a new prescription (high contrast, high luminance),
* Study frame characteristics: Frame B size at least 22 mm
Exclusion Criteria
* Participation in another study which might have an influence on vision or interfere with study assessments,
* Binocular vision problems,
* Known ocular pathology (e.g., age-related macular degeneration, glaucoma…),
* Any previous ocular surgery which might have an influence on vision or interfere with study assessments (e.g., iridectomy, refractive surgery…),
* Any untreated and/or uncontrolled systemic condition which might have an influence on vision, or interfere with study assessments (e.g., uncontrolled diabetes, uncontrolled high blood pressure…),
* Any medical treatment or medication that might have an influence on vision or interfere with study assessments (e.g., antidepressants, drugs with atropinic effects…),
* Knowledge/expertise in optometry, ophthalmic lenses, or optics based on past or current professional activity (e.g., optometrists, opticians, ophthalmologists…)
20 Years
39 Years
ALL
Yes
Sponsors
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Elite School of Optometry and Sankara Nethralaya
UNKNOWN
Essilor International
INDUSTRY
Responsible Party
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Other Identifiers
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ESS-TEC 191
Identifier Type: -
Identifier Source: org_study_id