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

Dry Eye Syndromes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05002036
• Other study ID #: OCU-OS-003/2019
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2021
• Est. completion date: May 1, 2021

Study information

• Verified date: July 2021
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Device:
• Trium eyedrops
given three times daily from day 1 after surgery to end of Week 4

Locations

Country	Name	City	State
Italy	University of Milano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes occurring between Day 1 vs Week 1 and Week 4
Primary	Ocular Surface Disease Index (OSDI)	A score ranging from 0 to 100 calculated by means of a questionnaire	Changes occurring between Day 1 vs Week 1 and Week 4
Secondary	Number of patients with TBUT of 5 sec or less		Changes occurring between Day 1 vs Week 1 and Week 4
Secondary	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	Changes occurring between Day 1 vs Week 1 and Week 4
Secondary	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)	Week 1, Week 4
Secondary	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)	Changes occurring between Day 1 vs Week 1 and Week 4