Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group 1 | Sodium Hyaluronate 0.15% and Dexpanthenol 2% drops (Hylopan max) |
| |
| Study Group 2 | Sodium Hyaluronate 0.15% and Trehalose 3% drops (Thealoz duo) |
| |
| Study Group 3 | Sodium Hyaluronate 0.2% and Amino acids drops (Helenvision ultra) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Hyaluronate 0.15% and Dexpanthenol 2% drops (Hylopan max) | Drug | Cataract patients will be administered Drops of Sodium Hyaluronate 0.15% and Dexpanthenol 2% quid in their postoperative regimen |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Surface Disease Index (OSDI) | A subjective parameter that quantifies corneal discomfort | 12 weeks |
| Tear Break-up Time (TBUT) | An objective parameter that quantifies stability of tear film | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Efron scale for bulbar redness |
Not provided
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:
Not provided
Not provided
Patients who underwent cataract extraction surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eirini - Kanella Panagiotopoulou, MD, MSc, PhD | Contact | +30 6978730858 | panagiotopoulou.ek@gmail.com | |
| Georgios Labiris, MD, Prof | Contact | +30 2551030990 | labiris@usa.net |
| Name | Affiliation | Role |
|---|---|---|
| Georgios Labiris, MD, Prof | Democritus University of Thrace | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Alexandroupolis | Alexandroupoli | Evros | 68100 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28497070 | Background | Labiris G, Ntonti P, Sideroudi H, Kozobolis V. Impact of polyethylene glycol 400/propylene glycol/hydroxypropyl-guar and 0.1% sodium hyaluronate on postoperative discomfort following cataract extraction surgery: a comparative study. Eye Vis (Lond). 2017 May 10;4:13. doi: 10.1186/s40662-017-0079-5. eCollection 2017. | |
| 30805405 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sodium Hyaluronate 0.15% and Trehalose 3% drops (Thealoz duo) | Drug | Cataract 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) | Drug | Cataract patients will be administered Drops of Sodium Hyaluronate 0.2% and Amino acids quid in their postoperative regimen |
|
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.
| 12 weeks |
| Ntonti P, Panagiotopoulou EK, Karastatiras G, Breyannis N, Tsironi S, Labiris G. Impact of 0.1% sodium hyaluronate and 0.2% sodium hyaluronate artificial tears on postoperative discomfort following cataract extraction surgery: a comparative study. Eye Vis (Lond). 2019 Feb 11;6:6. doi: 10.1186/s40662-019-0131-8. eCollection 2019. |
| ID | Term |
|---|---|
| D002386 | Cataract |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D007766 | Lacrimal Apparatus Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| C007288 | dexpanthenol |
| D014199 | Trehalose |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D005936 | Glucans |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D000073893 | Sugars |
Not provided
Not provided