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Completed

NCT Number: NCT05002036

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

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).

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Milano

Milan, 20142, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trium eyedrops

Device

given three times daily from day 1 after surgery to end of Week 4

Primary outcomes

  1. Tear Break-up time (TBUT), seconds

    Time frame: Changes occurring between Day 1 vs Week 1 and Week 4

    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

  2. Ocular Surface Disease Index (OSDI)

    Time frame: Changes occurring between Day 1 vs Week 1 and Week 4

    A score ranging from 0 to 100 calculated by means of a questionnaire

Secondary outcomes

  1. Number of patients with TBUT of 5 sec or less

    Time frame: Changes occurring between Day 1 vs Week 1 and Week 4

  2. Number of patients with corneal epithelial staining

    Time frame: Changes occurring between Day 1 vs Week 1 and Week 4

    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

  3. Judgement of quality of study medications

    Time frame: Week 1, Week 4

    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)

  4. Conjunctival hyperemia

    Time frame: Changes occurring between Day 1 vs Week 1 and Week 4

    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)

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 12, 2021
Registry last updated
Aug 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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