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

Last updated: August 3, 2021
Sponsor: University of Milan
Overall Status: Completed

Phase

4

Condition

Vision Loss

Eye Disorders/infections

Sjogren's Syndrome

Treatment

N/A

Clinical Study ID

NCT05002036
OCU-OS-003/2019
  • All Genders

Study 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

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.

Study Design

Total Participants: 40
Study Start date:
February 01, 2021
Estimated Completion Date:
May 01, 2021

Connect with a study center

  • University of Milano

    Milano, 20142
    Italy

    Site Not Available

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