Evaluation of Dry Eye Disease's Signs in Patients Who Were Administered Intravitreal Anti-VEGF Injections
- Conditions
- Dry Eye Syndromes
- Interventions
- Device: sham (Hydrabak)Device: Thealoz Duo;
- Registration Number
- NCT06317922
- Lead Sponsor
- Francesco Bandello
- Brief Summary
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:
* can ocular instillation of Thealoz Duo solution, 1 week before intravitreal injection, in a fixed dose regimen, prevent ocular surface changes and dry-eye signs?
* can ocular instillation of Thealoz Duo solution, up 3 months after intravitreal injections, in a fixed dose regimen, reduce ocular surface changes, and dry-eye signs with improvement of quality of life and quality of vision?
Each participant will be randomized into each of two arms:
1. TREATMENT ARM: patients who will receive the instillation of Thealoz Duo, 10 ml, 1 drop, 4 times/day;
2. CONTROL ARM: patients who will receive the instillation of saline solution (Hydrabak), 10 ml, 1 drop, 4 times /day;
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- patient with retinal disease who required anti-VEGF therapy via intravitreal injections;
- patient who has already received at least 2 anti-VEGF therapy via intravitreal injections in the study eye during the last 6 months before the baseline;
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- patient with naive retinal disease who has already received < 2 anti-VEGF therapy via intravitreal injections in the study eye;
- subjects with autoimmune pathologies involving the ocular surface (e.g.Sjögren's syndrome), dry eye syndrome, eyelid disease that can induce changes in ocular surface (e.g. entropion, ectropion, lagophthalmos, trichiasis, ptosis), with any other systemic disease that may confound the interpretation of study results.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control arm sham (Hydrabak) 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. treatment arm Thealoz Duo; 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.
- Primary Outcome Measures
Name Time Method Administration of Ocular Surface Disease Index (OSDI) to the patient 3 months and 1 week 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.
- Secondary Outcome Measures
Name Time Method Schirmer's test 3 months and 1 week The secondary outcome is to evaluate the improvements of ocular surface and signs related to dry eye disease, through:
-Schirmer's test.tear film Break Up Time (tBUT) 3 months and 1 week 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).conjunctival hyperemia according to Efron grading scale 3 months and 1 week 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).
fluorescein staining 3 months and 1 week The secondary outcome is to evaluate the improvements of ocular surface and signs related to dry eye disease, through:
-fluorescein staining.evaluation of matrix metalloproteinase 9 gene expression 3 months and 1 week 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.administration of Visual Analog Scale for Pain to the patient 3 months and 1 week 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').
TearLab Osmolarity 3 months and 1 week The secondary outcome is to evaluate the improvements of ocular surface and signs related to dry eye disease, through:
-TearLab Osmolarity.
Trial Locations
- Locations (1)
IRCCS Ospedale San Raffaele _O.U. Ophthalmology
🇮🇹Milan, Italy