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
| Name | Class |
|---|---|
| Naval Hospital, Athens | OTHER |
| George Papanicolaou Hospital | OTHER |
| Athinaiki General Clinic | OTHER |
Not provided
Not provided
Not provided
Primary objective of the study is the assessment of the patients' 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), the Naval Hospital in Athens, the Papanikolaou General Hospital in Thessaloniki, and Athinaiki General Clinic in Athens in a consecutive-if-eligible basis. By means of a custom computer randomization program all participants will randomly populate either study group [who will receive fixed combination of tobramycin and dexamethasone (FCTD), (Tobradex, Alcon, Greece) quid for 3 weeks and 0.2 % sodium hyaluronate (Hylogel, Pharmex, Greece) quid for 6 weeks], and control group [who will receive Tobradex quid for 3 weeks and 0.1 % sodium hyaluronate (Hylocomod) quid for 6 weeks].
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Active Comparator | Sodium Hyaluronate 0.1% drops |
|
| Control group | Active Comparator | Sodium Hyaluronate 0.2% drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Hyaluronate 0.1% drops | Drug | Patients will be administered Drops of Sodium Hyaluronate 0.1% quid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surface Discomfort Index | A subjective parameter that quantifies corneal discomfort | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Break up time | An objective parameter that quantifies stability of tear film | 6 weeks |
| Central Corneal Sensitivity | An objective parameter that quantifies corneal sensitivity |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Georgios Labiris, MD, PhD | University Hospital of Alexandroupolis, Democritus University of Thrace | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Alexandroupolis | Alexandroupoli | Evros | 68100 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30805405 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sodium Hyaluronate 0.2% drops | Drug | Patients will be administered Drops of Sodium Hyaluronate 0.2% quid |
|
|
| 6 weeks |