Management of Dry Eye Disease After Cataract Surgery With Topical Hyaluronic Acid and Gingko Biloba

University of Milan

Status and phase

Completed

Phase 4

Conditions

Dry Eye Syndromes

Treatments

Device: Trium eyedrops

Study type

Interventional

Funder types

Other

Identifiers

NCT05002036

OCU-OS-003/2019

Details and patient eligibility

About

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).

Enrollment

40 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.