Evaluation of the Effectiveness of Three Tear Substitute Formulations in Postoperative Discomfort After Cataract Surgery
- Sponsor
- Democritus University of Thrace
- Study ID
- NCT07581548
- Status
- Not Yet Recruiting
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Conditions
- Cataract
- Dry Eye
Eligibility Criteria
- Sex
- ALL
- Age
- 45 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- Sodium Hyaluronate 0.15% and Dexpanthenol 2% drops (Hylopan max) — DRUGCataract patients will be administered Drops of Sodium Hyaluronate 0.15% and Dexpanthenol 2% quid in their postoperative regimen
- Sodium Hyaluronate 0.15% and Trehalose 3% drops (Thealoz duo) — DRUGCataract patients will be administered Drops of Sodium Hyaluronate 0.15% and Trehalose 3% quid in their postoperative regimen
- Sodium Hyaluronate 0.2% and Amino acids drops (Helenvision ultra) — DRUGCataract patients will be administered Drops of Sodium Hyaluronate 0.2% and Amino acids quid in their postoperative regimen
Study Details
The primary objective of this study is the assessment of three tear substitute formulations in terms of postoperative discomfort following cataract extraction surgery by means of phacoemulsification and intraocular lens implantation.
Key Dates
- First listed
- May 12, 2026
- Start date
- May 1, 2026
- Status verified
- May 2026
- Primary completion
- Dec 31, 2026
- Completion
- May 1, 2027
Study Design
- Enrollment
- 300 participants (estimated)
Arms
- Arm: Study Group 1Sodium Hyaluronate 0.15% and Dexpanthenol 2% drops (Hylopan max)
- Arm: Study Group 2Sodium Hyaluronate 0.15% and Trehalose 3% drops (Thealoz duo)
- Arm: Study Group 3Sodium Hyaluronate 0.2% and Amino acids drops (Helenvision ultra)
Primary Outcome Measure
Ocular Surface Disease Index (OSDI) [ Time Frame: 12 weeks ]
Central Contacts
- Eirini - Kanella Panagiotopoulou, MD, MSc, PhD+30 6978730858
- Georgios Labiris, MD, Prof+30 2551030990
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