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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-05-01

Brief Summary

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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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Detailed Description

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Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HA-GB

eyedrop containing hyaluronic acid and gingko biloba (Trium eyedrops, Sooft srl)

Group Type ACTIVE_COMPARATOR

Trium eyedrops

Intervention Type DEVICE

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

No treatment

no treatment for iatrogenic dry-eye

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Trium eyedrops

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* At least 18 years old Cataract requiring surgery
* TBUT of 7" or more in both eyes.

Exclusion Criteria

* 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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No