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The goal of this interventional, monocentric, prospective, single-masked, case-control study is to evaluate the efficacy of Thealoz Duo (artificial tear containing trehalose 3 g and hyaluronic acid 0.15 g) in comparison to a saline solution (Hydrabak containing Sodium Chloride 0,9 g, Sodium Dihydrogen Phosphate Dihydrate, Disodium Hydrogen Phosphate Dodecahydrate), to reduce the signs of ocular discomfort and ocular side effects in patients who have received Intravitreal injections.
The main questions it aims to answer are:
Each participant will be randomized into each of two arms:
The decision of inclusion of a control group should minimize the risk of breaking the blinding condition by affecting the consistency and reliability of the outcome's achievement.
In any case, the instillation of saline solution should not alter the ocular surface.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment arm | Experimental | Installation of artificial tears of Thealoz DUO (Investigational medical device containing trehalose 3 g and hyaluronic acid 0.15 g ), 10 ml. Dosage:1 drop x 4 times/day by 1 week before the Intravitreal injection until 3 months afterward. |
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| control arm | Placebo Comparator | Installation of saline solution (Hydrabak containing Sodium Chloride 0,9 g, Sodium Dihydrogen Phosphate Dihydrate, Disodium Hydrogen Phosphate Dodecahydrate),10 ml. Dosage: 1 drop x 4 times/day by 1 week before the Intravitreal injection up to 3 months after it. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thealoz Duo; | Device | THEALOZ DUO is a solution containing trehalose (3%), sodium hyaluronate (0.15%), sodium chloride, trometamol, hydrochloric acid, and water for injections; Hydraback is a solution containing a sodium chloride 0.9 %, sodium dihydrogen phosphate dihydrate, sodium phosphate dodecahydrate, water for preparations for injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Administration of Ocular Surface Disease Index (OSDI) to the patient | The primary outcome is to evaluate the improvement of the dry-eye signs and changes in the ocular surface in patients who have received the intravitreal injections through the administration of Ocular Surface Disease Index (OSDI) at baseline, at month 1 and month 3 after the intravitreal injections. | 3 months and 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| administration of Visual Analog Scale for Pain to the patient | The Visual Analogue Scale measures pain intensity and consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could be'). | 3 months and 1 week |
| evaluation of matrix metalloproteinase 9 gene expression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emanuela Aragona, MD-PhD | Contact | +390226433512 | aragona.emanuela@hsr.it |
| Name | Affiliation | Role |
|---|---|---|
| Francesco Bandello, MD | IRCCS Ospedale San Raffaele | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Ospedale San Raffaele _O.U. Ophthalmology | Recruiting | Milan | 20123 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30623968 | Result | Cejka C, Kubinova S, Cejkova J. Trehalose in ophthalmology. Histol Histopathol. 2019 Jun;34(6):611-618. doi: 10.14670/HH-18-082. Epub 2019 Jan 9. | |
| 27445067 | Result | Chiambaretta F, Doan S, Labetoulle M, Rocher N, Fekih LE, Messaoud R, Khairallah M, Baudouin C; HA-trehalose Study Group. A randomized, controlled study of the efficacy and safety of a new eyedrop formulation for moderate to severe dry eye syndrome. Eur J Ophthalmol. 2017 Jan 19;27(1):1-9. doi: 10.5301/ejo.5000836. Epub 2016 Jul 20. |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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The participants will be randomized in two arms (treatment arm and control arm) in a ratio of 1:1.
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There are two teams:
MASKED TEAM: Sub-investigators and study coordinators delegated to perform the following tasks:
UNMASKED TEAMS:
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| sham (Hydrabak) | Device | Hydrabak is an ophthalmic solution containing: sodium chloride 0.9%, sodium dihydrogen phosphate dihydrate, sodium phosphate dodecahydrate, and water for injectable preparations |
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The secondary outcome is to evaluate the improvements of ocular surface and signs related to dry eye disease, through: -evaluation of matrix metalloproteinase 9 gene expression. |
| 3 months and 1 week |
| TearLab Osmolarity | The secondary outcome is to evaluate the improvements of ocular surface and signs related to dry eye disease, through: -TearLab Osmolarity. | 3 months and 1 week |
| Schirmer's test | The secondary outcome is to evaluate the improvements of ocular surface and signs related to dry eye disease, through: -Schirmer's test. | 3 months and 1 week |
| tear film Break Up Time (tBUT) | The secondary outcome is to evaluate the improvements of ocular surface and signs related to dry eye disease, through: -tear film Break Up Time (tBUT). | 3 months and 1 week |
| conjunctival hyperemia according to Efron grading scale | The Efron grading scale describe the severity of contact lens complications (grade 0: normal; grade 1: trace; grade 2: mild; grade 3: moderate; grade 4: severe). | 3 months and 1 week |
| fluorescein staining | The secondary outcome is to evaluate the improvements of ocular surface and signs related to dry eye disease, through: -fluorescein staining. | 3 months and 1 week |
| 28860698 | Result | Laude A, Lim JW, Srinagesh V, Tong L. The effect of intravitreal injections on dry eye, and proposed management strategies. Clin Ophthalmol. 2017 Aug 16;11:1491-1497. doi: 10.2147/OPTH.S136500. eCollection 2017. |
| 31237739 | Result | Dohlman TH, Lertsuwanroj B, D'Amico DJ, Ciralsky JB, Kiss S. Evaluation of signs and symptoms of ocular surface disease after intravitreal injection. Acta Ophthalmol. 2019 Dec;97(8):e1154-e1156. doi: 10.1111/aos.14146. Epub 2019 Jun 25. No abstract available. |
| 28166657 | Result | Saedon H, Nosek J, Phillips J, Narendran N, Yang YC. Ocular surface effects of repeated application of povidone iodine in patients receiving frequent intravitreal injections. Cutan Ocul Toxicol. 2017 Dec;36(4):343-346. doi: 10.1080/15569527.2017.1291665. Epub 2017 Feb 28. |