RECRUITINGOBSERVATIONAL
The Pattern of Dry Eye Disease After Cataract Surgery
Ocular Surface and Corneal Morphological Changes After the Cataract Surgery and Associations With Inflammatory Biomarkers
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 Should NOT Join This Trial:
- 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 conditions (where your immune system attacks your own body).
- Neurologic conditions including stroke, Bell's palsy, Parkinson's, trigeminal nerve dysfunction.
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* 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.
Treatments Being Tested
DEVICE
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.
Locations (1)
Lithuanian University of Health Sciences
Kaunas, Lithuania