Ocular Surface DiseaseNCT06555367
Clinical Application Research of Scleral Lenses in Ocular Surface Diseases
An observational study of Ocular Surface Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
To evaluate the therapeutic efficacy of scleral lenses in patients with irregular corneal astigmatism stemming from ocular surface diseases (OSD), focusing on visual acuity improvement, comfort, and overall satisfaction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Surface Disease
- What is being tested?
- scleral lenses
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 8 Aug 2024to 31 Aug 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with irregular corneal astigmatism who visited the ophthalmology clinic of the Second Affiliated Hospital of Zhejiang University for scleral lens fitting from January 2022 to June 2024 were selected. This includes patients with post-keratoconus cross-linking surgery, post-keratoplasty, and those with corneal irregularities caused by trauma.
Who may be able to join
- Patients with irregular corneal astigmatism, including those with post-keratoconus cross-linking surgery, post-keratoplasty, and corneal irregularities caused by trauma; Volunteers who are willing to participate in this trial, have signed the informed consent form, and are willing to cooperate with the treatment and follow-up; Individuals aged 18 years or older (including 18 years old), with no gender restrictions; Cases collected from January 2023 to August 2024.
Who cannot join
- Unable or unwilling to sign the consent form, or unable to follow the study procedures; Nursing or pregnant women; Individuals with acute ocular inflammation or infection; Corneal endothelium: Cell Density (CD) <1000/mm²; Individuals required to wear lenses overnight; Poor compliance; Those who do not meet the hygiene requirements for lens wear; Individuals whom the investigator deems have other reasons making them unsuitable for the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital of Zhejiang University Hospital
Hangzhou, Zhejiang
rui yi zhu, 15868805518, zhuyirui001@126.com
lin lin
About this study
To evaluate the therapeutic efficacy of scleral lenses in patients with irregular corneal astigmatism stemming from ocular surface diseases (OSD), focusing on visual acuity improvement, comfort, and overall satisfaction. This prospective clinical study enrolled patients diagnosed with OSD-related irregular corneal astigmatism. Participants underwent comprehensive ophthalmic evaluation, including corneal topography, visual acuity assessment, and tear film analysis. Qualified subjects were fitted with scleral lenses and followed up at intervals of one week, one month, and three months post-fitting. The primary outcomes measured were uncorrected and corrected visual acuity, comfort levels assessed via a standardized questionnaire, and fitting success rates. Data were analyzed using appropriate statistical methods to compare pre- and post-intervention values.
- Conditions
- Ocular Surface Disease
- Being tested
- scleral lenses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scleral lensesDevice
Wear scleral lenses
| Study group | Role | What they receive |
|---|---|---|
| scleral lenses group | The case group consists of patients with irregular corneas who wear scleral lenses. Receives: Device: scleral lenses | |
| control group | The control group comprises patients with irregular corneas who have not undergone treatment with scleral lenses. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scleral lens fitting assessment
The fitting assessment is conducted using a slit lamp microscope to observe the central positioning of the lens, the tear film space under the lens, and the vascular compression on the peripheral conjunctival surface. OCT is applied to measure the tear film space between the central and peripheral non-contact areas of the lens and the anterior corneal surface, as well as the landing zone of the lens in all peripheral directions.
Measured: 4 hours later
Secondary outcomes (1)
Subjective comfort assessment
Level 1: Very uncomfortable; Level 2: Uncomfortable; Level 3: Moderate comfort; Level 4: Comfortable; Level 5: Very comfortable.
Measured: 4 hours later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start8 Aug 2024 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ocular Surface DiseaseStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555367
- Sponsor's protocol ID
- 2024-0667
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhu Y, Cai J, Su L, Dong J, Zhou J, Zheng H, Mou Y, Jin X. Comparative Evaluation of Scleral Lens Treatment in Ocular Surface Diseases: A Prospective Study. J Ophthalmol. 2026 May 23;2026:1921583. doi: 10.1155/joph/1921583. eCollection 2026.
PubMed 42183401
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application Research of Scleral Lenses in Ocular Surface Diseases
- ClinicalTrials.gov ID
- NCT06555367
- Acronym / sponsor ID
- 2024-0667
- Conditions
- Ocular Surface Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 8 Aug 2024 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 15 Aug 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 therapeutic efficacy of scleral lenses in patients with irregular corneal astigmatism stemming from ocular surface diseases (OSD), focusing on visual acuity improvement, comfort, and overall satisfaction. This prospective clinical study enrolled patients diagnosed with OSD-related irregular corneal astigmatism. Participants underwent comprehensive ophthalmic evaluation, including corneal topography, visual acuity assessment, and tear film analysis. Qualified subjects were fitted with scleral lenses and followed up at intervals of one week, one month, and three months post-fitting. The primary outcomes measured were uncorrected and corrected visual acuity, comfort levels assessed via a standardized questionnaire, and fitting success rates. Data were analyzed using appropriate statistical methods to compare pre- and post-intervention values.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| scleral lenses group | – | Device: scleral lensesThe case group consists of patients with irregular corneas who wear scleral lenses. |
| control group | – | –The control group comprises patients with irregular corneas who have not undergone treatment with scleral lenses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with irregular corneal astigmatism who visited the ophthalmology clinic of the Second Affiliated Hospital of Zhejiang University for scleral lens fitting from January 2022 to June 2024 were selected. This includes patients with post-keratoconus cross-linking surgery, post-keratoplasty, and those with corneal irregularities caused by trauma.
Key inclusion criteria (1 listed)
- Patients with irregular corneal astigmatism, including those with post-keratoconus cross-linking surgery, post-keratoplasty, and corneal irregularities caused by trauma; Volunteers who are willing to participate in this trial, have signed the informed consent form, and are willing to cooperate with the treatment and follow-up; Individuals aged 18 years or older (including 18 years old), with no gender restrictions; Cases collected from January 2023 to August 2024.
Key exclusion criteria (1 listed)
- Unable or unwilling to sign the consent form, or unable to follow the study procedures; Nursing or pregnant women; Individuals with acute ocular inflammation or infection; Corneal endothelium: Cell Density (CD) <1000/mm²; Individuals required to wear lenses overnight; Poor compliance; Those who do not meet the hygiene requirements for lens wear; Individuals whom the investigator deems have other reasons making them unsuitable for the trial.
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 |
|---|---|---|
| scleral lensesWear scleral lenses | Device | scleral lenses group |
Primary outcome
Scleral lens fitting assessment
Time frame: 4 hours later
The fitting assessment is conducted using a slit lamp microscope to observe the central positioning of the lens, the tear film space under the lens, and the vascular compression on the peripheral conjunctival surface. OCT is applied to measure the tear film space between the central and peripheral non-contact areas of the lens and the anterior corneal surface, as well as the landing zone of the lens in all peripheral directions.
1 secondary outcome
Subjective comfort assessment
Time frame: 4 hours later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Derived from this study: PubMed 42183401Zhu Y, Cai J, Su L, Dong J, Zhou J, Zheng H, Mou Y, Jin X. Comparative Evaluation of Scleral Lens Treatment in Ocular Surface Diseases: A Prospective Study. J Ophthalmol. 2026 May 23;2026:1921583. doi: 10.1155/joph/1921583. eCollection 2026.
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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.
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, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 15 Aug 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 ming xiu jin (13989455778, 18344980412@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scleral lens fitting assessment (time frame: 4 hours later). 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 NCT06555367, which also lists 1 linked publication.
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 15 Aug 2024.