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| Name | Class |
|---|---|
| Santen Oy | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reda Zemaitiene | Contact | +37037327064 | reda.zemaitiene@lsmuni.lt | |
| Laura Kapitanovaite | Contact | +37037327064 | laura.kapitanovaite@kaunoklinikos.lt |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lithuanian University of Health Sciences | Recruiting | Kaunas | LT-44307 | Lithuania |
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.
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D007905 | Lens Diseases |
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| 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). | 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). | 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. | 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 | 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative. |
| Visual acuity evaluation (LogMAR) | Mean change from baseline. | 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative. |