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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HA-GB | Active Comparator | eyedrop containing hyaluronic acid and gingko biloba (Trium eyedrops, Sooft srl) |
|
| No treatment | No Intervention | no treatment for iatrogenic dry-eye |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trium eyedrops | Device | given three times daily from day 1 after surgery to end of Week 4 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion criteria were:
Exclusion criteria were:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Milano | Milan | 20142 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35442771 | Derived | Fogagnolo P, Romano D, De Ruvo V, Sabella P, Rossetti L. Clinical Efficacy of an Eyedrop Containing Hyaluronic Acid and Ginkgo Biloba in the Management of Dry Eye Disease Induced by Cataract Surgery. J Ocul Pharmacol Ther. 2022 May;38(4):305-310. doi: 10.1089/jop.2021.0123. Epub 2022 Apr 18. |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Changes occurring between Day 1 vs Week 1 and Week 4 |
| 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 |
| 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 |