Cataract surgery is one of the main causes of Dry Eye Disease (DED). This paper aimed at evaluating the prevalence of iatrogenic DED on a population of patients without DED receiving cataract surgery, and the impact of an eyedrop containing hyaluronic acid and gingko biloba (HA-GB, Trium free eyedrops, Sooft srl, Italy). In this phase-IV trial we enrolled 40 patients with no DED. Patients were seen at baseline, day 1, week 1 and week 4. At each visit patients received Ocular Surface Disease Index (OSDI) questionnaire, Anterior segment ophthalmoscopy with grading of conjunctival hyperemia, fluorescein tear break-up time (TBUT), grading of fluorescein corneal staining (epithelial damage); adherence and tolerability using a visual analogue scale were checked at week 1 and 4. At day 0 patients underwent cataract surgery (2.4 mm temporal incision) and were randomized to standard postoperative care (control group) or standard postoperative care + HA-GB given three times a day for 4 weeks (HA-GB group).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
given three times daily from day 1 after surgery to end of Week 4
University of Milano
Milan, Italy
Tear Break-up time (TBUT), seconds
The time (seconds) from blinking from the first break of the tear film stained with fluorescein and evaluated at the slit lamp with blue cobalt filter and 10x magnification
Time frame: Changes occurring between Day 1 vs Week 1 and Week 4
Ocular Surface Disease Index (OSDI)
A score ranging from 0 to 100 calculated by means of a questionnaire
Time frame: Changes occurring between Day 1 vs Week 1 and Week 4
Number of patients with TBUT of 5 sec or less
Time frame: Changes occurring between Day 1 vs Week 1 and Week 4
Number of patients with corneal epithelial staining
Staining was evaluated at the slit lamp with fluorescein dying, blue cobalt filter and 10x magnification. Staining was graded according to the Oxford scale, ranging from 0 (no staining) to 4
Time frame: Changes occurring between Day 1 vs Week 1 and Week 4
Judgement of quality of study medications
Patients were asked to judge the quality of study medications using a Visual analogue scale. The score was converted on a scale between 0 (very bad evaluation) and 100 (very high satisfaction)
Time frame: Week 1, Week 4
Conjunctival hyperemia
Assessed using diffuse white illumination at the slit lamp with 10x magnification. Results were reported using Efron scale, ranging from 0 (normal) to 4 (severe)
Time frame: Changes occurring between Day 1 vs Week 1 and Week 4
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