AsthenopiaNCT05089240
Objective and Subjective Evaluation of Ophthalmic Lenses With Extra Power
A study testing Ophthalmic lens with extra power in people with Asthenopia, run by Essilor International.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthenopia
- What is being tested?
- Ophthalmic lens with extra power
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- No sites listed yet
- Study dates
- 6 Jun 2016to 1 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
Show all 10Show fewer
- 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
Who cannot join
- 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…)
About this study
Official title: Data Collection of Objective Parameters and Subjective Feedback on Visually Fatigued Subjects and Evaluation of the Effect of Ophthalmic Lenses to Alleviate Visual Fatigue
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.
- Conditions
- Asthenopia
- Being tested
- Ophthalmic lens with extra power
- Medical subject headings
- Asthenopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ophthalmic lens with extra powerDevice
| Study group | Role | What they receive |
|---|---|---|
| 20-29 years (+0.40D extra power) | Other | Not described Receives: Device: Ophthalmic lens with extra power |
| 30-35 years (+0.40D extra power) | Other | Not described Receives: Device: Ophthalmic lens with extra power |
| 20-29 years (+0.40D extra power with blue cut) | Other | Not described Receives: Device: Ophthalmic lens with extra power |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after the first and second wearing period (21 days each)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start6 Jun 2016
- Primary completion2 Dec 2016
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthenopiaStudies of the same condition, open and under way.
- More trials run by Essilor InternationalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essilor International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Elite School of Optometry and Sankara Nethralaya
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089240
- Sponsor's protocol ID
- ESS-TEC 191
- Status last verified
- Oct 2021
- First submitted
- 28 Sep 2021
- Last updated
- 22 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection of Objective Parameters and Subjective Feedback on Visually Fatigued Subjects and Evaluation of the Effect of Ophthalmic Lenses to Alleviate Visual Fatigue
- ClinicalTrials.gov ID
- NCT05089240
- Acronym / sponsor ID
- ESS-TEC 191
- Conditions
- Asthenopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Essilor InternationalIndustry (pharma, biotech, devices)
- Collaborators
- Elite School of Optometry and Sankara Nethralaya
- Study start
- 6 Jun 2016 (actual)
- Primary completion
- 2 Dec 2016 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 20-29 years (+0.40D extra power) | Other | Device: Ophthalmic lens with extra power |
| 30-35 years (+0.40D extra power) | Other | Device: Ophthalmic lens with extra power |
| 20-29 years (+0.40D extra power with blue cut) | Other | Device: Ophthalmic lens with extra power |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (8 listed)
- 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…),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ophthalmic lens with extra power | Device | 20-29 years (+0.40D extra power with blue cut), 20-29 years (+0.40D extra power), 30-35 years (+0.40D extra power) |
Primary outcome
The difference in number of participants with treatment-related adverse events between the two lenses
Time frame: Immediately after the first and second wearing period (21 days each)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
Related trials for Asthenopia
Recruiting
Lactic Acid Bacteria for Reducing Blue Light-Induced Eye Fatigue
Digital Eye Strain (DES)
Not yet recruiting
Comparative Effects of Exercises on Pain, Cervical Proprioception, Neck Disability and Visual Performance in Patients With Computer Vision Syndrome.
Computer Vision Syndrome
Not yet recruiting
Study of Eye Fatigue From Digital Screens and Its Impact on Visual Performance in People With Normal Vision and Myopia, With and Without Dry Eye Symptoms and Signs
Myopia, Dry Eye Disease (DED)
Not yet recruiting
A Study of Full-Spectrum Screen Lighting for Reducing Screen-Related Eye Fatigue and Dry Eye
Visual Fatigue, Dry Eye
Not yet recruitingObservational study
Exploration Strategies in Night Vision Sensors
Visual Acuity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ophthalmic lens with extra power in people with Asthenopia, run by Essilor International.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in number of participants with treatment-related adverse events between the two lenses (time frame: Immediately after the first and second wearing period (21 days each)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.