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

August 3, 2021 updated by: Paolo Fogagnolo, University of Milan

Evaluation of the Clinical Efficacy of Hyaluronic Acid and Gingko Biloba Eyedrops in the Management of Iatrogenic Dry Eye Disease Induced by Cataract Surgery

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy, 20142
        • University of Milano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: HA-GB
eyedrop containing hyaluronic acid and gingko biloba (Trium eyedrops, Sooft srl)
Device: Trium eyedrops
given three times daily from day 1 after surgery to end of Week 4
No Intervention: No treatment
no treatment for iatrogenic dry-eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Changes occurring between Day 1 vs Week 1 and Week 4
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
Changes occurring between Day 1 vs Week 1 and Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with TBUT of 5 sec or less
Time Frame: Changes occurring between Day 1 vs Week 1 and Week 4
Changes occurring between Day 1 vs Week 1 and Week 4
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
Changes occurring between Day 1 vs Week 1 and Week 4
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)
Week 1, Week 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)
Changes occurring between Day 1 vs Week 1 and Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

May 1, 2021

Study Completion (Actual)

May 1, 2021

Study Registration Dates

First Submitted

July 28, 2021

First Submitted That Met QC Criteria

August 3, 2021

First Posted (Actual)

August 12, 2021

Study Record Updates

Last Update Posted (Actual)

August 12, 2021

Last Update Submitted That Met QC Criteria

August 3, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCU-OS-003/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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