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

Phase 4

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Device: Trium eyedrops

• Registration Number: NCT05002036
• Lead Sponsor: University of Milan

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Primary Completion: 2021-05-01
• Study Completion: 2021-05-01
• Status Verified: 2021-07
• Study First Submitted: 2021-07-28
• Study First Submitted QC: 2021-08-03
• Last Update Submitted: 2021-08-03
• Study First Posted: 2021-08-12
• Last Update Posted: 2021-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HA-GB	Trium eyedrops	eyedrop containing hyaluronic acid and gingko biloba (Trium eyedrops, Sooft srl)

Primary Outcome Measures

Name	Time	Method
Ocular Surface Disease Index (OSDI)	Changes occurring between Day 1 vs Week 1 and Week 4	A score ranging from 0 to 100 calculated by means of a questionnaire
Tear Break-up time (TBUT), seconds	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

Secondary Outcome Measures

Name	Time	Method
Judgement of quality of study medications	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)
Number of patients with TBUT of 5 sec or less	Changes occurring between Day 1 vs Week 1 and Week 4
Number of patients with corneal epithelial staining	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
Conjunctival hyperemia	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)

Trial Locations

Locations (1)

University of Milano; 🇮🇹 Milano, Italy