The Pattern of Dry Eye Disease After Cataract Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-90
SponsorLithuanian University of Health Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Artificial tears (sodium hyaluronate 0.2%)
DevicePatients 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Patients who will be using artificial tears before and after cataract surgery1 intervention
Group B: Patients who will not be using any artificial tears neither before nor after the cataract surgery.0 interventions
Trial outcomes
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.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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Lithuanian University of Health Sciences
Lead sponsor
Santen Oy
Collaborator
Source ClinicalTrials.gov