Dry Eye DiseaseNCT06298890
The Pattern of Dry Eye Disease After Cataract Surgery
An observational study of Dry Eye Disease and Cataract, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial summary
This study is designed to explore dry eye disease (DED) pattern: ocular surface, corneal morphological changes, patients' subjective assessment of DED and their correlations with ocular surface inflammation, pain biomarkers after cataract surgery according to ocular surface lubrication with artificial tears during… Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Dry Eye Disease, Cataract, Ocular Surface Disease
- What is being tested?
- Artificial tears (sodium hyaluronate 0.2%)
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteLithuania
- Study dates
- Mar 2024to Sep 2027
- Phase
- Observational
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participation in this study is voluntary. Research participants will be recruited during a routine visit to an ophthalmologist at Lithuanian University of Health Sciences Hospital Kaunas Clinics, Ophthalmology Department.
Who may be able to join
- Cataract patients from 50 to 90 years old who underwent uncomplicated phacoemulsification performed by one (and same) experienced surgeon.
- Patients with no underlying ocular surface diseases (keratitis, keratoconjunctivitis and others).
- Patients who previously did not undergo any ophthalmic surgery.
Who cannot join
- Patient expressed his wish to not participate in the study or discontinue it when already enrolled.
- Severe dry eye disease diagnosed with OSDI/DEQ-5 and at least one of the following tests: TBUT less than 10 seconds, tear osmolarity higher than 308 mOsm/l or positive corneal staining.
- Glaucoma.
- Diabetes mellitus.
- Systemic connective tissue disease, autoimmune disease.
- Neurologic conditions including stroke, Bell's palsy, Parkinson's, trigeminal nerve dysfunction.
Show all 10Show fewer
- Patients who underwent refractive surgery (LASIK or PRK).
- Contact lens users.
- One or more of the following concomitant medications: psychiatric medicines, antihistamines and/or hormonal replacement.
- Patients who are already regularly using topical drops or ointments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lithuania1 site, 1 recruiting
- Recruiting
Lithuanian University of Health Sciences
Kaunas, LT-44307
Reda Zemaitiene, + 370 37 327 201, rektoratas@lsmu.lt
About this study
Official title: Ocular Surface and Corneal Morphological Changes After the Cataract Surgery and Associations With Inflammatory Biomarkers
This study is designed to explore dry eye disease (DED) pattern: ocular surface, corneal morphological changes, patients' subjective assessment of DED and their correlations with ocular surface inflammation, pain biomarkers after cataract surgery according to ocular surface lubrication with artificial tears during long-term follow-up.
- Conditions
- Dry Eye Disease, Cataract, Ocular Surface Disease
- Being tested
- Artificial tears (sodium hyaluronate 0.2%)
- Medical subject headings
- Dry Eye Syndromes, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial tears (sodium hyaluronate 0.2%)Device
Patients randomised into Ist study group will use artificial tears 7 days before the cataract surgery 4 times a day and they will continue to use them after surgery for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Patients who will be using artificial tears before and after cataract surgery | Patients will receive artificial tears 7 days before the cataract surgery and continue to use them for 3 months after the surgery. Receives: Device: Artificial tears (sodium hyaluronate 0.2%) | |
| Patients who will not be using any artificial tears neither before nor after the cataract surgery. | Patients will not receive any artificial tears neither before nor after the cataract surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of ocular surface changes following cataract surgery
Measured using LacryDiag (Quantel Medical, France), parameters included: non-invasive tear break up time, the height of the tear meniscus, interferometry.
Measured: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
Evaluation of the cornea morphology
Evaluated performing confocal corneal microscopy, parameters include: corneal nerve fibre number and density.
Measured: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
Evaluation of matrix metalloproteinase-9 (MMP-9) levels in patients' tears
Matrix metalloproteinase 9 is an inflammatory biomarker that has been shown to be elevated in the tears of dry eye disease (DED) patients. MMP-9 testing is a valuable diagnostic tool in identifying the presence of ocular surface inflammation in DED patients. MMP-9 level results are classified as positive or negative.
Measured: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
Evaluation of tear osmolarity
Evaluated with the TearLab Osmolarity System. Increased osmolarity indicates dry eye. Values greater than 300 mOsm/kg are suggestive of dry eye. From 300 mOsm/L to 320 mOsm/L, is graded as mild; from 320 mOsm/L to 340 mOsm/L, is graded as moderate; and greater than 340 mOsm/L, is graded as severe.
Measured: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
Evaluation of tear cytokine levels
Interleukin -2, -6, -1β, tumour necrosis factor α (TNFα), interferon-gamma (IFN-γ) levels in tears are significantly higher in patients' with dry eye disease (DED) and they correlate with the severity of DED. Cytokine levels in tears will be evaluated using Human Immunotherapy Luminex® Performance Assay 25-plex Fixed Panel System.
Measured: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
Assessment of central corneal sensitivity
Measured using Cochet-Bonnet aesthesiometer (Luneau; Pruneay-Le-Gillon, France).
Measured: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
Secondary outcomes (5)
Evaluation of potential pain biomarkers in patients' saliva
Pain biomarkers which will be evaluated - soluble tumor necrosis factor-α receptor II (sTNFαRII), nerve growth factor (NGF), brain-derived neurotrophic factor (BDNF), secretory IgA (SIgA). Pain is a common complaint in both dry eye disease (DED) and post-cataract surgery.
Pain biomarkers will be evaluated using ELISA methods.
Measured: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
Dry Eye Questionnaire-5 (DEQ5) 5-item
The DEQ-5 consists of five questions that assess the following: frequency of watery eye, discomfort, and dryness (scored on a 0-4 scale) and late day discomfort and dryness intensity (scored on a 0 -5 scale).
Measured: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
Ocular surface disease index (OSDI)
OSDI is a 12-item questionnaire that assesses dry eye symptoms and the effects it has on vision-related function in the past week of the patient's life. The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on a 0 to 4 scale with 0 corresponding to "none of the time" and 4 corresponding to "all of the time.
Measured: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
Visual function (VFQ-25) questionnaire
The 25-item questionnaire has several subscale categories that assesses different aspects of health-related quality of life including overall health, overall vision, difficulty with near vision, difficulty with distance vision, limitations in social functioning due to vision, role limitations due to vision, dependency on others due to vision, mental health symptoms due to vision, future expectations for vision, driving difficulties, and pain and discomfort around the eyes
Measured: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
Visual acuity evaluation (LogMAR)
Mean change from baseline.
Measured: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study startMar 2024 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Santen Oy
- Responsible party
- Principal investigator, Reda Zemaitiene, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298890
- Sponsor's protocol ID
- SASKAT
- Status last verified
- Mar 2024
- First submitted
- 22 Feb 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If it is necessary (at the motivated request of the customer) to transfer data to the research customer or third parties, only depersonalised data will be transferred, but data transfer to third parties is not foreseen.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Surface and Corneal Morphological Changes After the Cataract Surgery and Associations With Inflammatory Biomarkers
- ClinicalTrials.gov ID
- NCT06298890
- Acronym / sponsor ID
- SASKAT
- Conditions
- Dry Eye Disease, Cataract, Ocular Surface Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Collaborators
- Santen Oy
- Study start
- Mar 2024 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 7 Mar 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.
This study is designed to explore dry eye disease (DED) pattern: ocular surface, corneal morphological changes, patients' subjective assessment of DED and their correlations with ocular surface inflammation, pain biomarkers after cataract surgery according to ocular surface lubrication with artificial tears during long-term follow-up.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who will be using artificial tears before and after cataract surgery | – | Device: Artificial tears (sodium hyaluronate 0.2%)Patients will receive artificial tears 7 days before the cataract surgery and continue to use them for 3 months after the surgery. |
| Patients who will not be using any artificial tears neither before nor after the cataract surgery. | – | –Patients will not receive any artificial tears neither before nor after the cataract surgery. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participation in this study is voluntary. Research participants will be recruited during a routine visit to an ophthalmologist at Lithuanian University of Health Sciences Hospital Kaunas Clinics, Ophthalmology Department.
Key inclusion criteria (3 listed)
- Cataract patients from 50 to 90 years old who underwent uncomplicated phacoemulsification performed by one (and same) experienced surgeon.
- Patients with no underlying ocular surface diseases (keratitis, keratoconjunctivitis and others).
- Patients who previously did not undergo any ophthalmic surgery.
Key exclusion criteria (10 listed)
- Patient expressed his wish to not participate in the study or discontinue it when already enrolled.
- Severe dry eye disease diagnosed with OSDI/DEQ-5 and at least one of the following tests: TBUT less than 10 seconds, tear osmolarity higher than 308 mOsm/l or positive corneal staining.
- Glaucoma.
- Diabetes mellitus.
- Systemic connective tissue disease, autoimmune 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 |
|---|---|---|
| Artificial tears (sodium hyaluronate 0.2%)Patients randomised into Ist study group will use artificial tears 7 days before the cataract surgery 4 times a day and they will continue to use them after surgery for 3 months. | Device | Patients who will be using artificial tears before and after cataract surgery |
Primary outcome
Assessment of ocular surface changes following cataract surgery
Time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
Measured using LacryDiag (Quantel Medical, France), parameters included: non-invasive tear break up time, the height of the tear meniscus, interferometry.
Evaluation of the cornea morphology
Time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
Evaluated performing confocal corneal microscopy, parameters include: corneal nerve fibre number and density.
Evaluation of matrix metalloproteinase-9 (MMP-9) levels in patients' tears
Time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
Matrix metalloproteinase 9 is an inflammatory biomarker that has been shown to be elevated in the tears of dry eye disease (DED) patients. MMP-9 testing is a valuable diagnostic tool in identifying the presence of ocular surface inflammation in DED patients. MMP-9 level results are classified as positive or negative.
Evaluation of tear osmolarity
Time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
Evaluated with the TearLab Osmolarity System. Increased osmolarity indicates dry eye. Values greater than 300 mOsm/kg are suggestive of dry eye. From 300 mOsm/L to 320 mOsm/L, is graded as mild; from 320 mOsm/L to 340 mOsm/L, is graded as moderate; and greater than 340 mOsm/L, is graded as severe.
Evaluation of tear cytokine levels
Time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
Interleukin -2, -6, -1β, tumour necrosis factor α (TNFα), interferon-gamma (IFN-γ) levels in tears are significantly higher in patients' with dry eye disease (DED) and they correlate with the severity of DED. Cytokine levels in tears will be evaluated using Human Immunotherapy Luminex® Performance Assay 25-plex Fixed Panel System.
Assessment of central corneal sensitivity
Time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
Measured using Cochet-Bonnet aesthesiometer (Luneau; Pruneay-Le-Gillon, France).
5 secondary outcomes
Evaluation of potential pain biomarkers in patients' saliva
Time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
Dry Eye Questionnaire-5 (DEQ5) 5-item
Time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
Ocular surface disease index (OSDI)
Time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
Visual function (VFQ-25) questionnaire
Time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
Visual acuity evaluation (LogMAR)
Time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
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 7 Mar 2024.
- Individual participant dataSharing planned: Undecided. If it is necessary (at the motivated request of the customer) to transfer data to the research customer or third parties, only depersonalised data will be transferred, but data transfer to third parties is not foreseen.
Related trials for Dry Eye Disease
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
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?
An observational study of Dry Eye Disease and Cataract, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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 3 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 7 Mar 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 Lithuania. 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 Reda Zemaitiene (+37037327064, reda.zemaitiene@lsmuni.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of ocular surface changes following cataract surgery (time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.). The study lists 6 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 7 Mar 2024.