Clinical trial NCT05002036: Management of Dry Eye Disease After Cataract Surgery With Topical Hyaluronic Acid and Gingko Biloba
Official title: Evaluation of the Clinical Efficacy of Hyaluronic Acid and Gingko Biloba Eyedrops in the Management of Iatrogenic Dry Eye Disease Induced by Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye Syndromes
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion criteria were:

* At least 18 years old Cataract requiring surgery
* TBUT of 7" or more in both eyes.

Exclusion criteria were:

* BUT of 6 seconds or less in one or both eyes
* Corneal staining of grade 2 or more using Oxford scale in one or both eyes
* Presence of corneal neuropathy (Cochet-Bonnet esthesiometry less than 50 mm) in one or both eyes
* Contact lens wear less than 30 days before surgery
* Neuropathic causes of dry eye (diabetes, long-standing contact lens wearing, previous ocular herpes infections)
* Autoimmune diseases
* Past or active ocular surface diseases (any corneal disease, cicatricial conjunctivitis, ocular surface burns, keratinization of the eyelid margin, Sjogren syndrome, corneal trauma)
* pregnant and lactating women pediatric patients or adolescents under 18 years
* ocular or general factors predisposing the patient to an increased risk for intraoperative complications, according to investigator's evaluation. These include (but are not limited to) pseudoexfoliation capsulae, complete cataract, iridodonesis, previous eye surgery, previous eye trauma, history of complicated cataract surgery in the fellow eye, benign prostatic hyperplasia under treatment.

Primary outcomes:
measure: Tear Break-up time (TBUT), seconds
timeFrame: Changes occurring between Day 1 vs Week 1 and Week 4
measure: Ocular Surface Disease Index (OSDI)
timeFrame: Changes occurring between Day 1 vs Week 1 and Week 4
Secondary outcomes:
measure: Number of patients with TBUT of 5 sec or less
timeFrame: Changes occurring between Day 1 vs Week 1 and Week 4
measure: Number of patients with corneal epithelial staining
timeFrame: Changes occurring between Day 1 vs Week 1 and Week 4
measure: Judgement of quality of study medications
timeFrame: Week 1, Week 4
measure: Conjunctival hyperemia
timeFrame: Changes occurring between Day 1 vs Week 1 and Week 4
Other outcomes:
Locations:
city: Milano
country: Italy
facility: University of Milano
Study officials:
References:
citation: Fogagnolo P, Romano D, De Ruvo V, Sabella P, Rossetti L. Clinical Efficacy of an Eyedrop Containing Hyaluronic Acid and Ginkgo Biloba in the Management of Dry Eye Disease Induced by Cataract Surgery. J Ocul Pharmacol Ther. 2022 May;38(4):305-310. doi: 10.1089/jop.2021.0123. Epub 2022 Apr 18.