Dry EyeNCT07657858
Effect of Dry Eye Treatment on Corneal Astigmatism Measurements
A study testing Sodium Hyaluronate Eye Drops in people with Dry Eye and Cataract, run by Jin Yang at 1 site in China.
Trial summary
This prospective single-center study evaluates the effect of dry eye disease and short-term ocular surface treatment on the agreement and repeatability of corneal astigmatism measurements in patients with age-related cataract. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Sodium Hyaluronate Eye Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2030
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with age-related cataract undergoing preoperative ocular examination.
- Ability to complete ocular surface evaluation, including the Ocular Surface
- Disease Index questionnaire, non-invasive tear film break-up time, tear meniscus height, Schirmer test, and ocular surface staining.
- Ability to complete repeated corneal astigmatism measurements using IOLMaster 700, Pentacam AXL, and iTrace Prime.
- Ability to maintain stable fixation during device measurements. Provision of written informed consent.
Who cannot join
- Previous ocular surgery or ocular trauma.
- Corneal degeneration, corneal dystrophy, or other corneal diseases that could affect corneal measurements.
- Active corneal or conjunctival infection.
- Uveitis.
- Use of any topical eye drops within 24 hours before examination.
- Use of antiglaucoma medications.
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- Contact lens wear within 1 month before examination.
- Previous or ongoing treatment for dry eye disease.
- Poor fixation during device measurements.
- Poor-quality measurements from any study device
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Baoxian Zhuo contact
China1 site, 1 recruiting
- Recruiting
Eye and ENT hospital of Fudan University
Shanghai, Shanghai Municipality, 200000
Xuanqiao Lin, 15088920668, 1532483480@qq.com
About this study
Official title: Effect of Dry Eye and Ocular Surface Treatment on Agreement and Repeatability of Corneal Astigmatism Measurements Among Three Devices
This prospective single-center study evaluates the effect of dry eye disease and short-term ocular surface treatment on the agreement and repeatability of corneal astigmatism measurements in patients with age-related cataract. Participants undergoing preoperative cataract evaluation are classified into a control group or a dry eye disease group according to ocular surface symptoms and objective tear film findings.
All participants undergo ocular surface assessment and repeated corneal measurements using three commonly used devices: IOLMaster 700, Pentacam AXL, and iTrace Prime. Measurements include keratometric corneal astigmatism, total corneal astigmatism, and vector components of astigmatism. Patients with dry eye disease receive 0.3% sodium hyaluronate eye drops four times daily for 2 weeks, after which ocular surface assessment and device measurements are repeated.
The primary objective is to determine whether dry eye disease reduces interdevice agreement and test-retest repeatability of corneal astigmatism measurements, and whether short-term ocular surface treatment improves measurement stability. Interdevice agreement is assessed using Bland-Altman analysis, and repeatability is evaluated using within-subject standard deviation, test-retest repeatability, and intraclass correlation coefficient.
- Being tested
- Sodium Hyaluronate Eye Drops
- Keywords
- Dry Eye Disease, Cataract, Corneal Astigmatism, Ocular Surface, ;Biometry
- Medical subject headings
- Dry Eye Syndromes, Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Hyaluronate Eye DropsDrug
0.3% sodium hyaluronate eye drops administered four times daily for 2 weeks in participants with dry eye disease.
| Study group | Role | What they receive |
|---|---|---|
| Control Cohort | No intervention | Patients with age-related cataract who did not meet the diagnostic criteria for dry eye disease. Participants underwent ocular surface evaluation and repeated corneal astigmatism measurements using IOLMaster 700, Pentacam AXL, and iTrace Prime. No ocular surface treatment was administered in this cohort. |
| Dry Eye Disease Cohort | Experimental | Patients with age-related cataract who met the diagnostic criteria for dry eye disease. Participants underwent baseline ocular surface evaluation and repeated corneal astigmatism measurements using IOLMaster 700, Pentacam AXL, and iTrace Prime. They then received 0.3% sodium hyaluronate eye drops four times daily for 2 weeks, followed by repeat ocular surface evaluation and device measurements using the same protocol. Receives: Drug: Sodium Hyaluronate Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interdevice Agreement of Corneal Astigmatism Measurements
Interdevice agreement of corneal astigmatism measurements among IOLMaster 700, Pentacam AXL, and iTrace Prime will be assessed using Bland-Altman analysis. Pairwise comparisons will be performed for IOLMaster 700 versus Pentacam AXL, IOLMaster 700 versus iTrace Prime, and Pentacam AXL versus iTrace Prime. The main parameters include keratometric corneal astigmatism, total corneal astigmatism, and their vector components J0 and J45. The mean difference and 95% limits of agreement will be calculated.
Measured: Baseline and 2 weeks after ocular surface treatment in the dry eye disease arm.
Test-Retest Repeatability of Corneal Astigmatism Measurements
Test-retest repeatability of corneal astigmatism measurements obtained using IOLMaster 700, Pentacam AXL, and iTrace Prime will be evaluated using three consecutive valid measurements from each device. The main parameters include keratometric corneal astigmatism, total corneal astigmatism, and their vector components J0 and J45. Repeatability will be assessed using within-subject standard deviation, test-retest repeatability calculated as 2.77 times the within-subject standard deviation, and intraclass correlation coefficient with 95% confidence intervals.
Measured: Baseline and 2 weeks after ocular surface treatment in the dry eye disease arm.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Jan 2026
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jin Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jin Yang, Eye & ENT Hospital of Fudan University
- Investigators
- Xuanqiao Lin, Doctor, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657858
- Sponsor's protocol ID
- DryEye-2026-001
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the dataset contains patient-level clinical examination data. Deidentified aggregate data may be available from the corresponding author upon reasonable request, subject to institutional approval and applicable privacy regulations.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dry Eye and Ocular Surface Treatment on Agreement and Repeatability of Corneal Astigmatism Measurements Among Three Devices
- ClinicalTrials.gov ID
- NCT07657858
- Acronym / sponsor ID
- DryEye-2026-001
- Keywords
- Dry Eye Disease, Cataract, Corneal Astigmatism, Ocular Surface, ;Biometry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Jin YangUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 18 Jun 2026 (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.
This prospective single-center study evaluates the effect of dry eye disease and short-term ocular surface treatment on the agreement and repeatability of corneal astigmatism measurements in patients with age-related cataract. Participants undergoing preoperative cataract evaluation are classified into a control group or a dry eye disease group according to ocular surface symptoms and objective tear film findings.
All participants undergo ocular surface assessment and repeated corneal measurements using three commonly used devices: IOLMaster 700, Pentacam AXL, and iTrace Prime. Measurements include keratometric corneal astigmatism, total corneal astigmatism, and vector components of astigmatism. Patients with dry eye disease receive 0.3% sodium hyaluronate eye drops four times daily for 2 weeks, after which ocular surface assessment and device measurements are repeated.
The primary objective is to determine whether dry eye disease reduces interdevice agreement and test-retest repeatability of corneal astigmatism measurements, and whether short-term ocular surface treatment improves measurement stability. Interdevice agreement is assessed using Bland-Altman analysis, and repeatability is evaluated using within-subject standard deviation, test-retest repeatability, and intraclass correlation coefficient.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Cohort | No intervention | –Patients with age-related cataract who did not meet the diagnostic criteria for dry eye disease. Participants underwent ocular surface evaluation and repeated corneal astigmatism measurements using IOLMaster 700, Pentacam AXL, and iTrace Prime. No ocular surface treatment was administered in this cohort. |
| Dry Eye Disease Cohort | Experimental | Drug: Sodium Hyaluronate Eye DropsPatients with age-related cataract who met the diagnostic criteria for dry eye disease. Participants underwent baseline ocular surface evaluation and repeated corneal astigmatism measurements using IOLMaster 700, Pentacam AXL, and iTrace Prime. They then received 0.3% sodium hyaluronate eye drops four times daily for 2 weeks, followed by repeat ocular surface evaluation and device measurements using the same protocol. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with age-related cataract undergoing preoperative ocular examination.
- Ability to complete ocular surface evaluation, including the Ocular Surface
- Disease Index questionnaire, non-invasive tear film break-up time, tear meniscus height, Schirmer test, and ocular surface staining.
- Ability to complete repeated corneal astigmatism measurements using IOLMaster 700, Pentacam AXL, and iTrace Prime.
- Ability to maintain stable fixation during device measurements. Provision of written informed consent.
Key exclusion criteria (10 listed)
- Previous ocular surgery or ocular trauma.
- Corneal degeneration, corneal dystrophy, or other corneal diseases that could affect corneal measurements.
- Active corneal or conjunctival infection.
- Uveitis.
- Use of any topical eye drops within 24 hours before examination.
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 |
|---|---|---|
| Sodium Hyaluronate Eye Drops0.3% sodium hyaluronate eye drops administered four times daily for 2 weeks in participants with dry eye disease. | Drug | Dry Eye Disease Cohort |
Primary outcome
Interdevice Agreement of Corneal Astigmatism Measurements
Time frame: Baseline and 2 weeks after ocular surface treatment in the dry eye disease arm.
Interdevice agreement of corneal astigmatism measurements among IOLMaster 700, Pentacam AXL, and iTrace Prime will be assessed using Bland-Altman analysis. Pairwise comparisons will be performed for IOLMaster 700 versus Pentacam AXL, IOLMaster 700 versus iTrace Prime, and Pentacam AXL versus iTrace Prime. The main parameters include keratometric corneal astigmatism, total corneal astigmatism, and their vector components J0 and J45. The mean difference and 95% limits of agreement will be calculated.
Test-Retest Repeatability of Corneal Astigmatism Measurements
Time frame: Baseline and 2 weeks after ocular surface treatment in the dry eye disease arm.
Test-retest repeatability of corneal astigmatism measurements obtained using IOLMaster 700, Pentacam AXL, and iTrace Prime will be evaluated using three consecutive valid measurements from each device. The main parameters include keratometric corneal astigmatism, total corneal astigmatism, and their vector components J0 and J45. Repeatability will be assessed using within-subject standard deviation, test-retest repeatability calculated as 2.77 times the within-subject standard deviation, and intraclass correlation coefficient with 95% confidence intervals.
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 18 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the dataset contains patient-level clinical examination data. Deidentified aggregate data may be available from the corresponding author upon reasonable request, subject to institutional approval and applicable privacy regulations.
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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.
Baoxian Zhuo contact
Xuanqiao Lin, Doctor study chair
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Hyaluronate Eye Drops in people with Dry Eye and Cataract, run by Jin Yang 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 5 inclusion and 10 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 18 Jun 2026. 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 Xuanqiao Lin, Doctor (+8615088920668, 1532483480@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interdevice Agreement of Corneal Astigmatism Measurements (time frame: Baseline and 2 weeks after ocular surface treatment in the dry eye disease arm.). 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?
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 18 Jun 2026.