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.
Participants will be recruited from the Cataract Service of the University Hospital of Alexandroupolis (UHA). All participants will be randomly assigned to three study groups. Study group 1 will receive a fixed combination of chloramphenicol and dexamethasone (Dexachlor, Cooper, Greece) quid for 4 weeks and 0.15 % sodium hyaluronate \& Dexpanthenol 2% (Hylopan max, Zwitter, Greece) quid for 12 weeks. Study group 2 will receive a fixed combination of chloramphenicol and dexamethasone (Dexachlor, Cooper, Greece) quid for 4 weeks and 0.15 % sodium hyaluronate \& Trehalose 3% (Thealoz duo, Thea, Greece) quid for 12 weeks. Study group 3 will receive a fixed combination of chloramphenicol and dexamethasone (Dexachlor, Cooper, Greece) quid for 4 weeks and 0.2% sodium hyaluronate and amino acids (Helenvision Ultra, Pharmex, Greece) quid for 12 weeks.
Study Type
OBSERVATIONAL
Enrollment
300
Cataract patients will be administered Drops of Sodium Hyaluronate 0.15% and Dexpanthenol 2% quid in their postoperative regimen
Cataract patients will be administered Drops of Sodium Hyaluronate 0.15% and Trehalose 3% quid in their postoperative regimen
Cataract patients will be administered Drops of Sodium Hyaluronate 0.2% and Amino acids quid in their postoperative regimen
University Hospital of Alexandroupolis
Alexandroupoli, Evros, Greece
Ocular Surface Disease Index (OSDI)
A subjective parameter that quantifies corneal discomfort
Time frame: 12 weeks
Tear Break-up Time (TBUT)
An objective parameter that quantifies stability of tear film
Time frame: 12 weeks
Schirmer test (basal tear production)
An objective test that assesses basal tear production alone using topical anesthetic drops, by removing the stimulus that triggers reflex tearing.
Time frame: 12 weeks
Efron scale for bulbar redness
A clinical tool consisting of five photographic, color-calibrated images (graded 0 to 4) that allow practitioners to classify the severity of conjunctival hyperaemia, ranging from normal to severe Grade 0: Normal, pale eyelid margin, minimal conjunctival vessels. Grade 1: Trace/Very Slight redness. Grade 2: Slight/Mild redness. Grade 3: Moderate redness. Grade 4: Severe redness.
Time frame: 12 weeks
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