MyopiaNCT05962528
Soft Contact Lens Fitting With Different Sagittal Height
A study testing Soft lens in people with Myopia, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
To evaluate whether there is a difference in subjective and objective fit of soft lenses with different sagittal height Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Soft lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 1 Dec 2024
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age more than 18 years
- No active eye disease
- 5 soft lenses for the experiment can be successfully worn and all examinations can be completed as required
Who cannot join
- Active eye disease
- BCVA less than 20/25
- Those who are too small or tight eyelids are not suitable for wearing soft lenses
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Eye Hospital
Tianjin, 300020
Tiejing Sun, MD, +8627306525, suntiejing0109@163.com
About this study
To evaluate whether there is a difference in subjective and objective fit of soft lenses with different sagittal height
- Conditions
- Myopia
- Being tested
- Soft lens
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft lensDevice
Patients were randomly fitted with five different designs of soft lenses
| Study group | Role | What they receive |
|---|---|---|
| Type 1 group | Experimental | Toric soft lens with high sagittal height Receives: Device: Soft lens |
| Type 2 group | Experimental | Toric soft lens with low sagittal height Receives: Device: Soft lens |
| Type 3 group | Experimental | Spherical soft lens with high sagittal height Receives: Device: Soft lens |
| Type 4 group | Experimental | Spherical soft lens with low sagittal height Receives: Device: Soft lens |
| Control group | Placebo comparator | Traditional spherical soft lens Receives: Device: Soft lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective questionnaire
The subjective questionnaire is a visual quality questionnaire developed by combining previous research and clinical symptoms, including whether there is foreign body sensation, pain, dry eyes, etc.The score ranges from 0 to 4, with the higher the score, the more obvious the symptoms
Measured: 1 day (Once time after wearing the soft lens)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Apr 2023
- Primary completion1 Jul 2023
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962528
- Sponsor's protocol ID
- KY2023024
- Status last verified
- Jul 2023
- First submitted
- 16 Jul 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Contact Lens Fitting With Different Sagittal Height
- ClinicalTrials.gov ID
- NCT05962528
- Acronym / sponsor ID
- KY2023024
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 27 Jul 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.
To evaluate whether there is a difference in subjective and objective fit of soft lenses with different sagittal height
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Type 1 group | Experimental | Device: Soft lensToric soft lens with high sagittal height |
| Type 2 group | Experimental | Device: Soft lensToric soft lens with low sagittal height |
| Type 3 group | Experimental | Device: Soft lensSpherical soft lens with high sagittal height |
| Type 4 group | Experimental | Device: Soft lensSpherical soft lens with low sagittal height |
| Control group | Placebo comparator | Device: Soft lensTraditional spherical soft lens |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age more than 18 years
- No active eye disease
- 5 soft lenses for the experiment can be successfully worn and all examinations can be completed as required
Key exclusion criteria (3 listed)
- Active eye disease
- BCVA less than 20/25
- Those who are too small or tight eyelids are not suitable for wearing soft 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 |
|---|---|---|
| Soft lensPatients were randomly fitted with five different designs of soft lenses | Device | Control group, Type 1 group, Type 2 group, Type 3 group, Type 4 group |
Primary outcome
Subjective questionnaire
Time frame: 1 day (Once time after wearing the soft lens)
The subjective questionnaire is a visual quality questionnaire developed by combining previous research and clinical symptoms, including whether there is foreign body sensation, pain, dry eyes, etc.The score ranges from 0 to 4, with the higher the score, the more obvious the symptoms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Myopia
RecruitingPhase 3
A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
Myopia
Active, not recruitingPhase 4
Odyssey Evaluation in Post LASIK Patients
Cataract
Recruiting
Evaluation of Orthokeratology Lenses With a 5MM Optic Zone Diameter
Myopia, Astigmatism
Recruiting
Wavelength Intervention for Nearsighted Kids
Myopia
Not yet recruiting
SmoothCore Orthokeratology Plus M.O.V.E. Lenses vs. M.O.V.E. Lenses Alone for Myopia Control in Children With High Myopia
High Myopia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soft lens in people with Myopia, 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Jul 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tiejing Sun, MD (+8627306525, suntiejing0109@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective questionnaire (time frame: 1 day (Once time after wearing the soft lens)). 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 27 Jul 2023.