Ocular Surface DiseaseNCT06256770
Evaluation of the Safety and Efficacy of Rigid Breathable Scleral Contact Lenses for the Correction of Ametropia
An observational study of Ocular Surface Disease and Irregular Astigmatism, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
To evaluate the short-term efficacy and safety of scleral contact lens in the clinical treatment of patients with irregular astigmatism after corneal transplantation by analyzing ocular parameters and ocular surface conditions of patients after corneal transplantation. Read more about this study
- Who is it for?
- Ages 8 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Ocular Surface Disease, Irregular Astigmatism, Contact Lens Complication
- How many people
- 176 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 1 Dec 2024
- 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 8 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients with corneal astigmatism
Who may be able to join
- 1.8 ≤ age ≤ 55 years old;2.The diopter of one or both eyes is -25.00~+25.00 D (including -25.00D and +25.00D), and corneal astigmatism caused by any reason (including keratoconus, irregular cornea) ≥0.75D.
Who cannot join
- 1.Patients who are judged by the investigator to be unsuitable for corneal endothelial cells;2.Dry eye ;3.Abnormal IOP ;4.Overt strabismus;5.Bacterial, fungal, viral and other active corneal infections;6. Being used may cause dry eyes or affect the eyeball or affect vision or affect the angle drugs such as membrane curvature;7.Corneal sensory, active corneal lesions;8.Conventional slit lamp microscopy and ophthalmoscopy, corneal diseases, iris cyclitis, chronic uveitis, cataract and vitreoretina related eye diseases disease or active and progressive disease;9.Other eye diseases: such as dacryocystitis, eyelid diseases and eyelid abnormalities or infections, eye muscle-related diseases, optic pathway diseases, glaucoma;10.Patients with systemic diseases that cause immunocompromise;History of allergy to contact lenses or contact lens care solution;11.History of allergy to contact lenses or contact lens care solution;12.Pregnant, lactating or planning to become pregnant in the near future;13.Subjects who are considered by the investigator to be unable to wear rigid contact lenses after comprehensively considering the corneal parameters, morphological characteristics and refractive examination results of the examination results;14.Those who have worn hard contact lenses within 30 days or soft hydrophilic contact lenses within 10 days;15.Those who participated in other drug clinical trials 3 months before screening and participated in other medical device clinical trials within 30 days;16.one-eyed patients;17.Those who have a strong sense of foreign body and cannot tolerate it and have poor compliance, and cannot be timely and regular to the medical institution for medical treatment as required;18.Other conditions judged by the investigator that the patient is not suitable for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Eye Hospital
Tianjin, Tianjin Municipality
yan wang, director, +862227313336, wangyan7143@vip.sina.com
About this study
Official title: A Trial Study on Evaluation the Safety and Efficacy of Rigid Breathable Scleral Contact Lenses (Model: KTSL ) of Astigmatism,Myopia or Hyperopia
To evaluate the short-term efficacy and safety of scleral contact lens in the clinical treatment of patients with irregular astigmatism after corneal transplantation by analyzing ocular parameters and ocular surface conditions of patients after corneal transplantation.
- Conditions
- Ocular Surface Disease, Irregular Astigmatism, Contact Lens Complication, Corneal Astigmatism
- Keywords
- Ocular Surface Disease, Irregular Astigmatism, Contact Lens Complication, Corneal Astigmatism
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| scleral contact lenses group | The selected patients were equipped with scleral contact lenses to evaluate their best corrected visual acuity, refraction, ocular surface condition, and fitting status of contact lenses. | |
| RGP group | The selected patients were equipped with RGP to evaluate their best corrected visual acuity, refraction, ocular surface condition, and fitting status of contact lenses. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of Best Corrected Vision Acuity
The percentage of eyes with best corrected visual acuity improved by two lines or more (compared to best corrected visual acuity with glasses) or 5.0 or greater (standard logarithmic visual acuity chart) after 1 month ± 7 days of contact lens wear.
Measured: One year
Secondary outcomes (1)
Best Corrected Visual Acuity and Refraction with Contact Lenses
- Contact lenses for best corrected visual acuity. List the visual acuity of wearing glasses 7 days±3 days,1 month±7 days, and 3 months±14 days after wearing glasses. To provide the statistical analysis results of spectacle visual acuity in the experimental group and the control group;
- Diopter. The diopters of 7 days±3 days,1 month±7 days, and 3 months±14 days after wearing glasses were listed, and the results of diopter analysis in the experimental group and the control group were provided.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start1 Nov 2022
- Primary completion1 Sep 2024 (estimated)
- 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 Ocular Surface DiseaseStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Wang, Prof, Study chair, Tianjin Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256770
- Sponsor's protocol ID
- zhangyi2023
- Status last verified
- Feb 2023
- First submitted
- 5 Feb 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Study on Evaluation the Safety and Efficacy of Rigid Breathable Scleral Contact Lenses (Model: KTSL ) of Astigmatism,Myopia or Hyperopia
- ClinicalTrials.gov ID
- NCT06256770
- Acronym / sponsor ID
- zhangyi2023
- Conditions
- Ocular Surface Disease, Irregular Astigmatism, Contact Lens Complication, Corneal Astigmatism
- Keywords
- Ocular Surface Disease, Irregular Astigmatism, Contact Lens Complication, Corneal Astigmatism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 13 Feb 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.
To evaluate the short-term efficacy and safety of scleral contact lens in the clinical treatment of patients with irregular astigmatism after corneal transplantation by analyzing ocular parameters and ocular surface conditions of patients after corneal transplantation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| scleral contact lenses group | – | –The selected patients were equipped with scleral contact lenses to evaluate their best corrected visual acuity, refraction, ocular surface condition, and fitting status of contact lenses. |
| RGP group | – | –The selected patients were equipped with RGP to evaluate their best corrected visual acuity, refraction, ocular surface condition, and fitting status of contact lenses. |
Who may qualify
- Ages
- 8 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients with corneal astigmatism
Key inclusion criteria (1 listed)
- 1.8 ≤ age ≤ 55 years old;2.The diopter of one or both eyes is -25.00~+25.00 D (including -25.00D and +25.00D), and corneal astigmatism caused by any reason (including keratoconus, irregular cornea) ≥0.75D.
Key exclusion criteria (1 listed)
- 1.Patients who are judged by the investigator to be unsuitable for corneal endothelial cells;2.Dry eye ;3.Abnormal IOP ;4.Overt strabismus;5.Bacterial, fungal, viral and other active corneal infections;6. Being used may cause dry eyes or affect the eyeball or affect vision or affect the angle drugs such as membrane curvature;7.Corneal sensory, active corneal lesions;8.Conventional slit lamp microscopy and ophthalmoscopy, corneal diseases, iris cyclitis, chronic uveitis, cataract and vitreoretina related eye diseases disease or active and progressive disease;9.Other eye diseases: such as dacryocystitis, eyelid diseases and eyelid abnormalities or infections, eye muscle-related diseases, optic pathway diseases, glaucoma;10.Patients with systemic diseases that cause immunocompromise;History of allergy to contact lenses or contact lens care solution;11.History of allergy to contact lenses or contact lens care solution;12.Pregnant, lactating or planning to become pregnant in the near future;13.Subjects who are considered by the investigator to be unable to wear rigid contact lenses after comprehensively considering the corneal parameters, morphological characteristics and refractive examination results of the examination results;14.Those who have worn hard contact lenses within 30 days or soft hydrophilic contact lenses within 10 days;15.Those who participated in other drug clinical trials 3 months before screening and participated in other medical device clinical trials within 30 days;16.one-eyed patients;17.Those who have a strong sense of foreign body and cannot tolerate it and have poor compliance, and cannot be timely and regular to the medical institution for medical treatment as required;18.Other conditions judged by the investigator that the patient is not suitable for enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Improvement of Best Corrected Vision Acuity
Time frame: One year
The percentage of eyes with best corrected visual acuity improved by two lines or more (compared to best corrected visual acuity with glasses) or 5.0 or greater (standard logarithmic visual acuity chart) after 1 month ± 7 days of contact lens wear.
1 secondary outcome
Best Corrected Visual Acuity and Refraction with Contact Lenses
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
Yan Wang, Prof study chair
Tianjin Eye Hospital
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 Ocular Surface Disease and Irregular 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: status not confirmed, as of the sponsor's last update on 13 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinyu Yang (022-27313336, yxydoctor0725@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of Best Corrected Vision Acuity (time frame: One year). 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 13 Feb 2024.