Cataract, Dry Eye
Conditions
Keywords
dry eye, cataract surgery, sodium hyaluronate, artificial tears
Brief summary
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.
Detailed description
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.
Interventions
DRUGSodium Hyaluronate 0.15% and Dexpanthenol 2% drops (Hylopan max)
Cataract patients will be administered Drops of Sodium Hyaluronate 0.15% and Dexpanthenol 2% quid in their postoperative regimen
DRUGSodium Hyaluronate 0.15% and Trehalose 3% drops (Thealoz duo)
Cataract patients will be administered Drops of Sodium Hyaluronate 0.15% and Trehalose 3% quid in their postoperative regimen
DRUGSodium Hyaluronate 0.2% and Amino acids drops (Helenvision ultra)
Cataract patients will be administered Drops of Sodium Hyaluronate 0.2% and Amino acids quid in their postoperative regimen
Sponsors
Democritus University of Thrace
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
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
1. Former incisional surgery 2. Former diagnosis of corneal disease 3. Autoimmune diseases 4. Mental diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tear Break-up Time (TBUT) | 12 weeks | An objective parameter that quantifies stability of tear film |
| Ocular Surface Disease Index (OSDI) | 12 weeks | A subjective parameter that quantifies corneal discomfort |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efron scale for bulbar redness | 12 weeks | 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. |
| Schirmer test (basal tear production) | 12 weeks | An objective test that assesses basal tear production alone using topical anesthetic drops, by removing the stimulus that triggers reflex tearing. |
Countries
Greece
Contacts
CONTACTEirini - Kanella Panagiotopoulou, MD, MSc, PhD
CONTACTGeorgios Labiris, MD, Prof
STUDY_CHAIRGeorgios Labiris, MD, Prof
Democritus University of Thrace
Outcome results
None listed