AstigmatismNCT06694051
Application of Phototherapeutic Keratectomy Mode to Mark the Axis of Astigmatism
A study testing marking in people with Astigmatism, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
Corneal refractive surgery is an effective way to correct refractive error. Modern corneal refractive surgery for the correction of myopia or hyperopia can achieve or close to the expected goal, but to eliminate astigmatism is always one of the major problems of corneal refractive surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Astigmatism
- What is being tested?
- marking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least 18 years old
Who cannot join
- ocular disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Eye Hospital
Tianjin, Tianjin Municipality, 300020
Yan Wang, +86 022 27313336, wangyan7143@vip.sina.com
About this study
Corneal refractive surgery is an effective way to correct refractive error. Modern corneal refractive surgery for the correction of myopia or hyperopia can achieve or close to the expected goal, but to eliminate astigmatism is always one of the major problems of corneal refractive surgery. The key point in the correction of astigmatism is that as a vector parameter, astigmatism has both magnitude and direction. The angle error may be caused by the rotation of the patient's head position and the involuntary rotation of eyes. Phototherapeutic keratectomy can precisely cut the corneal tissue, and is often used in clinic to remove corneal scars or repair corneal surface morphology. In this study, the excimer laser therapeutic keratectomy mode was used to achieve accurate marking of the axis of astigmatism by setting the treatment laser parameters. With the help of the static cyclotorsion of the eye, the precise treatment of astigmatism could realize.
- Conditions
- Astigmatism
- Being tested
- marking
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
markingProcedure or surgery
axis marking
| Study group | Role | What they receive |
|---|---|---|
| ptk-group | Experimental | Not described Receives: Procedure: marking |
| limbus-group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
refraction
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start1 Oct 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstigmatismStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT06694051
- Sponsor's protocol ID
- KY-2024055
- Status last verified
- Nov 2024
- First submitted
- 15 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Phototherapeutic Keratectomy Mode to Mark the Axis of Astigmatism
- ClinicalTrials.gov ID
- NCT06694051
- Acronym / sponsor ID
- KY-2024055
- Conditions
- Astigmatism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Nov 2024 (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.
Corneal refractive surgery is an effective way to correct refractive error. Modern corneal refractive surgery for the correction of myopia or hyperopia can achieve or close to the expected goal, but to eliminate astigmatism is always one of the major problems of corneal refractive surgery. The key point in the correction of astigmatism is that as a vector parameter, astigmatism has both magnitude and direction. The angle error may be caused by the rotation of the patient's head position and the involuntary rotation of eyes. Phototherapeutic keratectomy can precisely cut the corneal tissue, and is often used in clinic to remove corneal scars or repair corneal surface morphology. In this study, the excimer laser therapeutic keratectomy mode was used to achieve accurate marking of the axis of astigmatism by setting the treatment laser parameters. With the help of the static cyclotorsion of the eye, the precise treatment of astigmatism could realize.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ptk-group | Experimental | Procedure: marking |
| limbus-group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- at least 18 years old
Key exclusion criteria (1 listed)
- ocular disease
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 |
|---|---|---|
| markingaxis marking | Procedure or surgery | ptk-group |
Primary outcome
refraction
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing marking in people with Astigmatism, 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 1 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: looking for participants now, as of the sponsor's last update on 19 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wang (+86 022 27313336, jiamei3536@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
refraction (time frame: 3 months). 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 19 Nov 2024.