The Pattern of Dry Eye Disease After Cataract Surgery

Browse trials for

• Cataract 1,701
• Dry Eye Syndromes 1,292
• Keratoconjunctivitis Sicca 795
• Eye Diseases 740

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's planned enrollment of 100 is above the median of 81 across 484 observational studies indexed under Cataract.

Lead sponsor

Lithuanian University of Health Sciences is the lead sponsor of 102 studies on the registry; 31 are open to participants now.

Study population

Groups and cohorts

• 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.

  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.

Interventions

• DeviceArtificial 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.

Primary outcomes

1. 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.

   Time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.

2. Evaluation of the cornea morphology

   Evaluated performing confocal corneal microscopy, parameters include: corneal nerve fibre number and density.

   Time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.

3. 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.

   Time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.

4. 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.

   Time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.

5. 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.

   Time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.

6. Assessment of central corneal sensitivity

   Measured using Cochet-Bonnet aesthesiometer (Luneau; Pruneay-Le-Gillon, France).

   Time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.

Secondary outcomes

1. 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.

   Time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.

2. 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).

   Time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.

3. 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.

   Time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.

4. 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

   Time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.

5. Visual acuity evaluation (LogMAR)

   Mean change from baseline.

   Time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.

Individual participant data

Plan to share: 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.