MyopiaNCT05684302
The Effect of the Free-toroidal Design Lenses on the Subjective Visual Quality in the Myopic Population
An observational study of Myopia and Refractive Errors, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
A prospective, self-control, double-blind design was conducted in Tianjin. Two hundred participants were assigned to wear two kinds of spectacle glasses. To examine the effect of free-toroidal design and aspherical lens on the subjective visual quality among the myopic population. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Myopia, Refractive Errors
- What is being tested?
- The free-toroidal design lenses
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 24 Dec 2021
- Phase
- Observational
- 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 18 to 50 years
- All sexes
- Adult
Study population: Healthy myopic people between 18 and 50 years of age
Who may be able to join
- health volunteers
- their spherical refraction from -0.50 to -8.00 Diopter, with the cylinder diopter less than -3.00 Diopter
- best corrected visual acuity (BCVA)≥ 20/20 in both eyes
- stable refraction (no change greater than 0.5 Diopter within two years)
Who cannot join
- if they had Aphakic or intraocular lens eyes, had a history of trauma, active eye disease or ocular surgery, serious systemic diseases, or had a wearing history of corneal contact lenses.
Trial locations and contacts
1 site in 1 country.
About this study
A prospective, self-control, double-blind design was conducted in Tianjin. Two hundred participants were assigned to wear two kinds of spectacle glasses. To examine the effect of free-toroidal design and aspherical lens on the subjective visual quality among the myopic population.
Read the detailed description
A prospective, self-control, double-blind design was conducted in Tianjin. Two hundred participants were assigned to wear two kinds of spectacle glasses. To examine the effect of free-toroidal design and aspherical lens on the subjective visual quality among the myopic population. The subjective visual quality of clarity and comfort were determined using a questionnaire when first wearing the glasses and after 1week.
- Conditions
- Myopia, Refractive Errors
- Being tested
- The free-toroidal design lenses
- Medical subject headings
- Myopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The free-toroidal design lensesOther
Participants were asked to wear the new design lenses (the free-toroidal design lenses) for 1 week
What is being measured
The primary outcome is the main question the study is designed to answer.
The clarity score
The clarity score by a questionnaire,scores on the questionnaire range from 1 to 6, with higher scores being better
Measured: baseline visit time
The comfort score
The comfort score by a questionnaire,scores on the questionnaire range from 1 to 6, with higher scores being better
Measured: baseline visit time
Secondary outcomes (1)
Accuracy of foveal and peripheral visual acuity
Accuracy of foveal and peripheral visual acuity was assessed by the eye movement tracking device
Measured: baseline visit time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start1 Jan 2021
- Primary completion24 Dec 2021
- Study completion24 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684302
- Sponsor's protocol ID
- KY202101
- Status last verified
- Dec 2022
- First submitted
- 24 Dec 2022
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jalie M. Modern spectacle lens design. Clin Exp Optom. 2020 Jan;103(1):3-10. doi: 10.1111/cxo.12930. Epub 2019 Jun 20.
PubMed 31222837Gannon C, Liang R. Evolving expertise for automated lens optimization. Appl Opt. 2020 Aug 1;59(22):G129-G136. doi: 10.1364/AO.391888.
PubMed 32749325
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Free-toroidal Design Lenses on the Subjective Visual Quality in the Myopic Population
- ClinicalTrials.gov ID
- NCT05684302
- Acronym / sponsor ID
- KY202101
- Conditions
- Myopia, Refractive Errors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 24 Dec 2021 (actual)
- Study completion
- 24 Dec 2021 (actual)
- First posted
- 13 Jan 2023 (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.
A prospective, self-control, double-blind design was conducted in Tianjin. Two hundred participants were assigned to wear two kinds of spectacle glasses. To examine the effect of free-toroidal design and aspherical lens on the subjective visual quality among the myopic population.
Detailed description
A prospective, self-control, double-blind design was conducted in Tianjin. Two hundred participants were assigned to wear two kinds of spectacle glasses. To examine the effect of free-toroidal design and aspherical lens on the subjective visual quality among the myopic population. The subjective visual quality of clarity and comfort were determined using a questionnaire when first wearing the glasses and after 1week.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- Healthy myopic people between 18 and 50 years of age
Key inclusion criteria (4 listed)
- health volunteers
- their spherical refraction from -0.50 to -8.00 Diopter, with the cylinder diopter less than -3.00 Diopter
- best corrected visual acuity (BCVA)≥ 20/20 in both eyes
- stable refraction (no change greater than 0.5 Diopter within two years)
Key exclusion criteria (1 listed)
- if they had Aphakic or intraocular lens eyes, had a history of trauma, active eye disease or ocular surgery, serious systemic diseases, or had a wearing history of corneal contact lenses.
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 |
|---|---|---|
| The free-toroidal design lensesParticipants were asked to wear the new design lenses (the free-toroidal design lenses) for 1 week | Other | – |
Primary outcome
The clarity score
Time frame: baseline visit time
The clarity score by a questionnaire,scores on the questionnaire range from 1 to 6, with higher scores being better
The comfort score
Time frame: baseline visit time
The comfort score by a questionnaire,scores on the questionnaire range from 1 to 6, with higher scores being better
1 secondary outcome
Accuracy of foveal and peripheral visual acuity
Time frame: baseline visit time
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 13 Jan 2023.
- Background: PubMed 31222837Jalie M. Modern spectacle lens design. Clin Exp Optom. 2020 Jan;103(1):3-10. doi: 10.1111/cxo.12930. Epub 2019 Jun 20.
- Background: PubMed 32749325Gannon C, Liang R. Evolving expertise for automated lens optimization. Appl Opt. 2020 Aug 1;59(22):G129-G136. doi: 10.1364/AO.391888.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia and Refractive Errors, run by Tianjin Eye Hospital at 1 site in China.
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 4 inclusion and 1 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 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 clarity score (time frame: baseline visit time). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05684302, which also lists 2 linked publications.
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 13 Jan 2023.