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study the effect of different concentrations of benzalkonium chloride on the ocular surface of non-dry-eyed patients post cataract surgery.
60 eyes of will be included in this study.
Preoperative assessment:
All selected patients will receive thorough explanation of the study design and aims, an informed consent will be obtained from all patients.
Tear break up time (TBUT) will be measured non-invasively by Ocular Surface analyzer.
Ocular Surface disease index will be calculated by filling a questionnaire. 12-item questionnaire provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning.
Postoperative:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | 20 eyes received single dose unit Dexathalm containing: actives: In 1ml: Dexamethason 1mg and Netilimicin 3mg, without preservatives 5 times per day. |
|
| Group B | Active Comparator | 20 eyes received regular Tobradex eye drops containing actives: In 1 ml: tobramycin 3 mg and dexamethasone 1 mg, preservative: 0.1mg of BAK per ml 5 times per day. |
|
| Group C | Active Comparator | 20 eyes received Dexathalm multi-dose containing actives: In 1ml: Dexamethasone 1mg and Netilimicin 3mg, preservatives: 0.05mg of BAK per ml 5 times per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone, tobramycin, netilimicin | Drug | Group A: Dexathalm single dose Group B: Tobradex Group C: Dexathalm multi-dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| NBUT | non invasive tear break up time | preoperative and 1 month postoperative |
| TMH | Tear meniscus Height | preoperative and 1 month postoperative |
| OSDI | ocular surface disease index | preoperative and 1 month postoperative |
| MG loss | meibomian gland loss | preoperative and 1 month postoperative |
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Inclusion Criteria:
Exclusion Criteria:
Preoperative non-invasive TBUT<10 seconds. Patients who have rheumatoid arthritis or autoimmune diseases affecting corneal surface.
Involutional entropion or ectropion preoperative Postoperative significant corneal edema requiring medication.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KasrAl Ainy Hospital | Cairo | Giza Governorate | 11956 | Egypt |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D014031 | Tobramycin |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D009328 | Nebramycin |
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |