An observational study in Cataract and Dry Eye, sponsored by Democritus University of Thrace. Not yet recruiting at 1 site in Greece. Open to participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by Democritus University of Thrace · Observational
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.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's planned enrollment of 300 is above the median of 89 across 475 observational studies indexed under Cataract.
Browse Cataract studies →Democritus University of Thrace is the lead sponsor of 70 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who underwent cataract extraction surgery
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of senile cataract with stage 2 or 3 nuclear opalescence according to the - Lens Opacities Classification System III (LOCS-3) grading scale
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sodium Hyaluronate 0.15% and Dexpanthenol 2% drops (Hylopan max)
Drug: Sodium Hyaluronate 0.15% and Dexpanthenol 2% drops (Hylopan max)
Sodium Hyaluronate 0.15% and Trehalose 3% drops (Thealoz duo)
Drug: Sodium Hyaluronate 0.15% and Trehalose 3% drops (Thealoz duo)
Sodium Hyaluronate 0.2% and Amino acids drops (Helenvision ultra)
Drug: Sodium Hyaluronate 0.2% and Amino acids drops (Helenvision ultra)
Drug page: Hyaluronic Acid
Cataract patients will be administered Drops of Sodium Hyaluronate 0.15% and Dexpanthenol 2% quid in their postoperative regimen
Drug page: Hyaluronic Acid
Cataract patients will be administered Drops of Sodium Hyaluronate 0.15% and Trehalose 3% quid in their postoperative regimen
Drug page: Hyaluronic Acid
Cataract patients will be administered Drops of Sodium Hyaluronate 0.2% and Amino acids quid in their postoperative regimen
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
Start is estimated for May 2026; primary completion for Dec 2026, 7 months later.
Of 167 non-industry observational studies under Cataract, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 30. This study's planned 7 months is below that.
Counting every sponsor, half of 234 studies reached it within 16 months; a quarter within 9 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Democritus University of Thrace