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Primary objective of the study is the assessment of the patients' discomfort and ocular redness 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) 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 Systane Ultra as additional postoperative treatment) and control group (who will receive standard postoperative treatment).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Systane ultra group | Active Comparator | Participants in this group were administered systane ultra quid (Alcon, Fort Worth) for two months postoperatively), additionally to tobradex quid (Alcon, Fort Worth) for 20 days postoperatively. |
|
| Control group | Active Comparator | Participants in this group were administered the standard postoperative medication [tobradex quid (Alcon, Fort Worth) for 20 days postoperatively.] |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systane Ultra | Drug | Further to standard medication (tobradex quid for 20 days), participants were administered Systane Ultra quid for 2 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Foreign body sensation | Foreign body sensation will be assessed by a direct 5-scale, Likert type question that will be addressed to the participants at the 30th postoperative day | 1 month postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Redness | Ocular redness will be assessed by means of a validated photographic chart | 7 days postoperatively |
| Corneal Sensitivity | Corneal Sensitivity will be assessed by Cochet-Bonnet esthesiometer at the 7th and 30th postoperative day |
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Inclusion Criteria:
1. 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:
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| Name | Affiliation | Role |
|---|---|---|
| Georgios Labiris, MD, PhD | Assistant Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Institute Of thrace | Alexandroupoli | Evros | 68100 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28497070 | Derived | 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. |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C022030 | methylacetylene |
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| tobradex quid (Standard) | Drug | Standard medication (tobradex quid for 20 days) |
|
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| 1 month postoperatively |