Dry Eye DiseaseNCT06656403
Effect of Artificial Tears on Ocular Biometry Parameters
A study testing 0.1% sodium hyaluronate in people with Dry Eye Disease and Tear Film, run by He Eye Hospital.
Trial summary
Due to the instability of the tear film, the biometry often needs to be done multiple times in a clinical environment. The high variability of both short-term and long-term repeatability in keratometry of dry eyes is well-known. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Disease, Tear Film
- What is being tested?
- 0.1% sodium hyaluronate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2024to 21 Nov 2024
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age ≥18 years,(2) able and willing to comply with the treatment schedule.
Who cannot join
- The eyes cannot fixate on the fixation lamp (such as children, nystagmus diseases, severe low vision, inattention, etc.) and cannot act according to the user's instructions and sit in the front of the equipment (the forehead or lower song is injured so that it cannot be supported on the forehead / lower song bracket)
- The eyes are cloudy with optical media (such as corneal opacity, central corneal scar, mature cataract, posterior chamber bag opacity, vitreous hemorrhage, etc.).
- The eyelid is completely closed or too small (drooping, relaxation) resulting in complete or partial occlusion of the cornea
- Just after contact measurement or examination, use a corneal local anesthesia solution. (IOL Master 700 should avoid using local anesthetic before all contact examinations)
- Tear film deformation (lack of specular reflection of the cornea during corneal curvature measurement), the severity of grade IV dry eye, and whether eye drops were used 24 hours before the examination.
- Any corneal lesions (corneal irregularity, corneal scar or corrosive burning, severe irregular astigmatism of cornea)
Show all 9Show fewer
- Fundus lesions (changes in the anatomical morphology of retinal macular fovea during axial length measurement, such as retinal detachment, edema, ulcer, etc.)
- Patients with ocular trauma, surgery, and excessive photosensitivity, such as photodynamic therapy (PDT), were excluded.
- using eye drops (0.1% Sodium hyaluronate) allergic patients
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Due to the instability of the tear film, the biometry often needs to be done multiple times in a clinical environment. The high variability of both short-term and long-term repeatability in keratometry of dry eyes is well-known. Consequently, enhancing the condition of the eye surface in individuals with dry eyes will result in improved precision when choosing the power of intraocular lenses (IOLs). This prospective and before-and-after self-control study will recruit 100 patients.
Read the detailed description
Over the past ten years, surgery has progressed from rejuvenation surgery to refractive surgery, which focuses on enhancing both vision and addressing pre-existing issues that impact visual quality. This is why good surgical outcomes involve thorough preoperative assessment and precise intraocular lens(IOL) power determination. To achieve the intended postoperative refractive outcomes, it is essential to perform an accurate calculation of intraocular lens power (i.e., biometry), which may impact the accuracy of the computation.
Damage to the eye's surface from chronic inflammation and induced tear film hyperosmolarity occurs in DED because tear film homeostasis is disrupted. The changes in tear film dynamics and damage to the ocular surface result in mistakes in optical measures, which in turn affect the results of procedures like cataract surgery that heavily rely on these assessments.
Consequently, enhancing the condition of the eye surface in individuals with dry eyes will result in improved precision when choosing the power of intraocular lenses (IOLs).
- Conditions
- Dry Eye Disease, Tear Film
- Being tested
- 0.1% sodium hyaluronate
- Keywords
- dry eye, IOL Master 700, tear film
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.1% sodium hyaluronateDrug
After baseline measurement, 0.1% sodium hyaluronate eye drops were instillation into the inferior conjunctival vault of both eyes
| Study group | Role | What they receive |
|---|---|---|
| Study group | Other | dry eye patients Receives: Drug: 0.1% sodium hyaluronate |
| Control group | Other | non-dry eye patients Receives: Drug: 0.1% sodium hyaluronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
flat meridian of the anterior corneal surface (K1)
K1 was measured using IOL Master 700 for 4 times. To assess the Biometry measurements were assesssed at baseline, 2nd ,3rd and 4th(30-second, 2-minute and 5-minute intervals respectively) time after instilling one drop of ATD (0.1% Sodium hyaluronate, preservative free)
Measured: Baseline,30s,2min,5min
steep meridian of the anterior corneal surface (K2)
K2 was measured using IOL Master 700 for 4 times. To assess the Biometry measurements were assesssed at baseline, 2nd ,3rd and 4th(30-second, 2-minute and 5-minute intervals respectively) time after instilling one drop of ATD (0.1% Sodium hyaluronate, preservative free)
Measured: Baseline,30s,2min,5min
central corneal thickness (CCT)
CCT was measured using IOL Master 700 for 4 times. To assess the Biometry measurements were assesssed at baseline, 2nd ,3rd and 4th(30-second, 2-minute and 5-minute intervals respectively) time after instilling one drop of ATD (0.1% Sodium hyaluronate, preservative free)
Measured: Baseline,30s,2min,5min
Secondary outcomes (8)
axial length (AL)
AL was measured using IOL Master 700 for 4 times. To assess the Biometry measurements were assesssed at baseline, 2nd ,3rd and 4th(30-second, 2-minute and 5-minute intervals respectively) time after instilling one drop of ATD (0.1% Sodium hyaluronate, preservative free)
Measured: Baseline,30s,2min,5min
corneal curvature radius(R1,R2)
R1,R2 was measured using IOL Master 700 for 4 times. To assess the Biometry measurements were assesssed at baseline, 2nd ,3rd and 4th(30-second, 2-minute and 5-minute intervals respectively) time after instilling one drop of ATD (0.1% Sodium hyaluronate, preservative free)
Measured: Baseline,30s,2min,5min
anterior chamber depth (ACD)
ACD was measured using IOL Master 700 for 4 times. To assess the Biometry measurements were assesssed at baseline, 2nd ,3rd and 4th(30-second, 2-minute and 5-minute intervals respectively) time after instilling one drop of ATD (0.1% Sodium hyaluronate, preservative free)
Measured: Baseline,30s,2min,5min
white-to-white corneal diameter (WTW)
WTW was measured using IOL Master 700 for 4 times. To assess the Biometry measurements were assesssed at baseline, 2nd ,3rd and 4th(30-second, 2-minute and 5-minute intervals respectively) time after instilling one drop of ATD (0.1% Sodium hyaluronate, preservative free)
Measured: Baseline,30s,2min,5min
Pupil (Pup)
Pup was measured using IOL Master 700 for 4 times. To assess the Biometry measurements were assesssed at baseline, 2nd ,3rd and 4th(30-second, 2-minute and 5-minute intervals respectively) time after instilling one drop of ATD (0.1% Sodium hyaluronate, preservative free)
Measured: Baseline,30s,2min,5min
non-invasive tear break-up time (NITBUT)
Non-invasive first tear film breakup time using the Keratograph 5M (Oculus, Germany) topographer will be measured three times consecutively and the median value was recorded
Measured: Baseline
tear meniscus height(TMH)
TMH using the Keratograph 5M (Oculus, Germany) topographer will be measured three times consecutively and the median value was recorded
Measured: Baseline
ocular surface disease index(OSDI)
Chinese translated, and validated OSDI (Allergan Inc, Irvine, USA) version will be used to assess and quantify DE symptom. The 12 items of the questionnaire can be tabulated into a score that ranges from 0 (no symptoms) to 100 (severe symptoms) points
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start30 Oct 2024 (estimated)
- Primary completion20 Nov 2024 (estimated)
- Study completion21 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Dry Eye 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- He Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guanghao Qin, Principal investigator, He Eye Specialist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656403
- Sponsor's protocol ID
- IOL2024
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Roggla V, Leydolt C, Schartmuller D, Schwarzenbacher L, Meyer E, Abela-Formanek C, Menapace R. Influence of Artificial Tears on Keratometric Measurements in Cataract Patients. Am J Ophthalmol. 2021 Jan;221:1-8. doi: 10.1016/j.ajo.2020.08.024. Epub 2020 Aug 21.
PubMed 32828877Nibandhe AS, Donthineni PR. Understanding and Optimizing Ocular Biometry for Cataract Surgery in Dry Eye Disease: A Review. Semin Ophthalmol. 2023 Jan;38(1):24-30. doi: 10.1080/08820538.2022.2112699. Epub 2022 Aug 20.
PubMed 35989638Chen X, Yuan F, Wu L. Metaanalysis of intraocular lens power calculation after laser refractive surgery in myopic eyes. J Cataract Refract Surg. 2016 Jan;42(1):163-70. doi: 10.1016/j.jcrs.2015.12.005.
PubMed 26948792Koh S. Irregular Astigmatism and Higher-Order Aberrations in Eyes With Dry Eye Disease. Invest Ophthalmol Vis Sci. 2018 Nov 1;59(14):DES36-DES40. doi: 10.1167/iovs.17-23500.
PubMed 30481804Koh S, Tung CI, Inoue Y, Jhanji V. Effects of tear film dynamics on quality of vision. Br J Ophthalmol. 2018 Dec;102(12):1615-1620. doi: 10.1136/bjophthalmol-2018-312333. Epub 2018 Jun 15.
PubMed 29907632Epitropoulos AT, Matossian C, Berdy GJ, Malhotra RP, Potvin R. Effect of tear osmolarity on repeatability of keratometry for cataract surgery planning. J Cataract Refract Surg. 2015 Aug;41(8):1672-7. doi: 10.1016/j.jcrs.2015.01.016.
PubMed 26432124Sheard R. Optimising biometry for best outcomes in cataract surgery. Eye (Lond). 2014 Feb;28(2):118-25. doi: 10.1038/eye.2013.248. Epub 2013 Dec 6.
PubMed 24310239Hovanesian J, Epitropoulos A, Donnenfeld ED, Holladay JT. The Effect of Lifitegrast on Refractive Accuracy and Symptoms in Dry Eye Patients Undergoing Cataract Surgery. Clin Ophthalmol. 2020 Sep 16;14:2709-2716. doi: 10.2147/OPTH.S264520. eCollection 2020.
PubMed 32982163Sahin A, Hamrah P. Clinically relevant biometry. Curr Opin Ophthalmol. 2012 Jan;23(1):47-53. doi: 10.1097/ICU.0b013e32834cd63e.
PubMed 22081032
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Artificial Tears on Ocular Biometry Parameters
- ClinicalTrials.gov ID
- NCT06656403
- Acronym / sponsor ID
- IOL2024
- Conditions
- Dry Eye Disease, Tear Film
- Keywords
- dry eye, IOL Master 700, tear film
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- He Eye HospitalUniversity, hospital or other
- Study start
- 30 Oct 2024 (estimated)
- Primary completion
- 20 Nov 2024 (estimated)
- Study completion
- 21 Nov 2024 (estimated)
- First posted
- 24 Oct 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.
Due to the instability of the tear film, the biometry often needs to be done multiple times in a clinical environment. The high variability of both short-term and long-term repeatability in keratometry of dry eyes is well-known. Consequently, enhancing the condition of the eye surface in individuals with dry eyes will result in improved precision when choosing the power of intraocular lenses (IOLs). This prospective and before-and-after self-control study will recruit 100 patients.
Detailed description
Over the past ten years, surgery has progressed from rejuvenation surgery to refractive surgery, which focuses on enhancing both vision and addressing pre-existing issues that impact visual quality. This is why good surgical outcomes involve thorough preoperative assessment and precise intraocular lens(IOL) power determination. To achieve the intended postoperative refractive outcomes, it is essential to perform an accurate calculation of intraocular lens power (i.e., biometry), which may impact the accuracy of the computation.
Damage to the eye's surface from chronic inflammation and induced tear film hyperosmolarity occurs in DED because tear film homeostasis is disrupted. The changes in tear film dynamics and damage to the ocular surface result in mistakes in optical measures, which in turn affect the results of procedures like cataract surgery that heavily rely on these assessments.
Consequently, enhancing the condition of the eye surface in individuals with dry eyes will result in improved precision when choosing the power of intraocular lenses (IOLs).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Other | Drug: 0.1% sodium hyaluronatedry eye patients |
| Control group | Other | Drug: 0.1% sodium hyaluronatenon-dry eye patients |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- age ≥18 years,(2) able and willing to comply with the treatment schedule.
Key exclusion criteria (9 listed)
- The eyes cannot fixate on the fixation lamp (such as children, nystagmus diseases, severe low vision, inattention, etc.) and cannot act according to the user's instructions and sit in the front of the equipment (the forehead or lower song is injured so that it cannot be supported on the forehead / lower song bracket)
- The eyes are cloudy with optical media (such as corneal opacity, central corneal scar, mature cataract, posterior chamber bag opacity, vitreous hemorrhage, etc.).
- The eyelid is completely closed or too small (drooping, relaxation) resulting in complete or partial occlusion of the cornea
- Just after contact measurement or examination, use a corneal local anesthesia solution. (IOL Master 700 should avoid using local anesthetic before all contact examinations)
- Tear film deformation (lack of specular reflection of the cornea during corneal curvature measurement), the severity of grade IV dry eye, and whether eye drops were used 24 hours before the 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 |
|---|---|---|
| 0.1% sodium hyaluronateAfter baseline measurement, 0.1% sodium hyaluronate eye drops were instillation into the inferior conjunctival vault of both eyes | Drug | Control group, Study group |
Primary outcome
flat meridian of the anterior corneal surface (K1)
Time frame: Baseline,30s,2min,5min
K1 was measured using IOL Master 700 for 4 times. To assess the Biometry measurements were assesssed at baseline, 2nd ,3rd and 4th(30-second, 2-minute and 5-minute intervals respectively) time after instilling one drop of ATD (0.1% Sodium hyaluronate, preservative free)
steep meridian of the anterior corneal surface (K2)
Time frame: Baseline,30s,2min,5min
K2 was measured using IOL Master 700 for 4 times. To assess the Biometry measurements were assesssed at baseline, 2nd ,3rd and 4th(30-second, 2-minute and 5-minute intervals respectively) time after instilling one drop of ATD (0.1% Sodium hyaluronate, preservative free)
central corneal thickness (CCT)
Time frame: Baseline,30s,2min,5min
CCT was measured using IOL Master 700 for 4 times. To assess the Biometry measurements were assesssed at baseline, 2nd ,3rd and 4th(30-second, 2-minute and 5-minute intervals respectively) time after instilling one drop of ATD (0.1% Sodium hyaluronate, preservative free)
8 secondary outcomes
axial length (AL)
Time frame: Baseline,30s,2min,5min
corneal curvature radius(R1,R2)
Time frame: Baseline,30s,2min,5min
anterior chamber depth (ACD)
Time frame: Baseline,30s,2min,5min
white-to-white corneal diameter (WTW)
Time frame: Baseline,30s,2min,5min
Pupil (Pup)
Time frame: Baseline,30s,2min,5min
non-invasive tear break-up time (NITBUT)
Time frame: Baseline
tear meniscus height(TMH)
Time frame: Baseline
ocular surface disease index(OSDI)
Time frame: Baseline
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 24 Oct 2024.
- Background: PubMed 32828877Roggla V, Leydolt C, Schartmuller D, Schwarzenbacher L, Meyer E, Abela-Formanek C, Menapace R. Influence of Artificial Tears on Keratometric Measurements in Cataract Patients. Am J Ophthalmol. 2021 Jan;221:1-8. doi: 10.1016/j.ajo.2020.08.024. Epub 2020 Aug 21.
- Background: PubMed 35989638Nibandhe AS, Donthineni PR. Understanding and Optimizing Ocular Biometry for Cataract Surgery in Dry Eye Disease: A Review. Semin Ophthalmol. 2023 Jan;38(1):24-30. doi: 10.1080/08820538.2022.2112699. Epub 2022 Aug 20.
- Background: PubMed 26948792Chen X, Yuan F, Wu L. Metaanalysis of intraocular lens power calculation after laser refractive surgery in myopic eyes. J Cataract Refract Surg. 2016 Jan;42(1):163-70. doi: 10.1016/j.jcrs.2015.12.005.
- Background: PubMed 30481804Koh S. Irregular Astigmatism and Higher-Order Aberrations in Eyes With Dry Eye Disease. Invest Ophthalmol Vis Sci. 2018 Nov 1;59(14):DES36-DES40. doi: 10.1167/iovs.17-23500.
- Background: PubMed 29907632Koh S, Tung CI, Inoue Y, Jhanji V. Effects of tear film dynamics on quality of vision. Br J Ophthalmol. 2018 Dec;102(12):1615-1620. doi: 10.1136/bjophthalmol-2018-312333. Epub 2018 Jun 15.
- Background: PubMed 26432124Epitropoulos AT, Matossian C, Berdy GJ, Malhotra RP, Potvin R. Effect of tear osmolarity on repeatability of keratometry for cataract surgery planning. J Cataract Refract Surg. 2015 Aug;41(8):1672-7. doi: 10.1016/j.jcrs.2015.01.016.
- Background: PubMed 24310239Sheard R. Optimising biometry for best outcomes in cataract surgery. Eye (Lond). 2014 Feb;28(2):118-25. doi: 10.1038/eye.2013.248. Epub 2013 Dec 6.
- Background: PubMed 32982163Hovanesian J, Epitropoulos A, Donnenfeld ED, Holladay JT. The Effect of Lifitegrast on Refractive Accuracy and Symptoms in Dry Eye Patients Undergoing Cataract Surgery. Clin Ophthalmol. 2020 Sep 16;14:2709-2716. doi: 10.2147/OPTH.S264520. eCollection 2020.
- Background: PubMed 22081032Sahin A, Hamrah P. Clinically relevant biometry. Curr Opin Ophthalmol. 2012 Jan;23(1):47-53. doi: 10.1097/ICU.0b013e32834cd63e.
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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.
Guanghao Qin principal investigator
He Eye Specialist Hospital
Questions about this trial
What is this clinical trial studying?
A study testing 0.1% sodium hyaluronate in people with Dry Eye Disease and Tear Film, run by He Eye Hospital.
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 9 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: opening soon, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Guanghao Qin (+86-18842664420, qinguanghao2020@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
flat meridian of the anterior corneal surface (K1) (time frame: Baseline,30s,2min,5min). The study lists 3 primary outcomes in all. 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 NCT06656403, which also lists 9 linked publications.
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 24 Oct 2024.