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CompletedNCT05089240Updated Oct 22, 2021

Objective and Subjective Evaluation of Ophthalmic Lenses With Extra Power

An interventional study of Ophthalmic lens with extra power in Asthenopia, sponsored by Essilor International. Completed. Open to participants aged 20 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-22.

Sponsored by Essilor International · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 5 years 3 months after the study started (first participant enrolled Jun 2016, registered Sep 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
127
Allocation
Randomized
Ages
20 Years to 39 Years
Sex
All
01

Study summary

To evaluate subjective visual performance and objective visual parameters when wearing ophthalmic lenses with extra power (+0.4 D or +0.6 D), and ophthalmic lenses with a selective blue cut filter.

02

Conditions studied

  • Asthenopia

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03

In context

Asthenopia

67 studies on the registry are indexed under Asthenopia; 10 are open to participants now.

This study's enrollment of 127 is above the median of 56 across 56 interventional studies indexed under Asthenopia.

Browse Asthenopia studies →

Lead sponsor

Essilor International is the lead sponsor of 38 studies on the registry; 20 are open to participants now.

Browse EssilorLuxottica studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 39 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjective report of visual fatigue
  • 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

Exclusion Criteria:

  • Vulnerability of the subject,
  • 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...)
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
127 participants (actual)

Study arms

  • Other
    20-29 years (+0.40D extra power)

    Device: Ophthalmic lens with extra power

  • Other
    30-35 years (+0.40D extra power)

    Device: Ophthalmic lens with extra power

  • Other
    20-29 years (+0.40D extra power with blue cut)

    Device: Ophthalmic lens with extra power

Interventions

  • DeviceOphthalmic lens with extra power
06

What researchers measure

Primary outcomes

  1. The difference in number of participants with treatment-related adverse events between the two lenses

    Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device. Determined by subject's spontaneous reporting, the Investigator's non-leading questioning and his/her evaluation.

    Time frame: Immediately after the first and second wearing period (21 days each)

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2016 to primary completion in Dec 2016, 5 months.

Of 38 interventional studies with no phase under Asthenopia, half reached primary completion within 3 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 9. This study's 5 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 28, 2021
First posted
Oct 22, 2021
StartActual
Jun 6, 2016
Primary completionActual
Dec 2, 2016
CompletionActual
Jul 1, 2017
Last update
Oct 22, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05089240
Lead sponsor
Essilor International
Collaborators
Elite School of Optometry and Sankara Nethralaya
Responsible party
Sponsor
First posted
Oct 22, 2021
Start date
Jun 6, 2016
Primary completion
Dec 2, 2016
Completion
Jul 1, 2017
Last update
Oct 22, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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