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 |
|---|---|
| State University of Montes Claros | UNKNOWN |
| Conselho Nacional de Desenvolvimento Científico e Tecnológico | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Clinical trial for prevention, randomized controlled, parallel, double-blind, with three arms, which purpose is verify the nursing interventions (artificial tear gel and liquid artificial tears)effects to prevent dry eye in adult patients admitted in ICU.
Critically ill patients are at higher risk for dry eye and the mechanisms responsible for ocular lubrication and protection can be compromised. However, the literature diverges on which is the best clinical practice for treatment. Thus, the general objective of this study was to evaluate the risk for developing dry eye in critically ill patients and the effectiveness of three types of interventions: eye gel and eyedrops (control group). The specific objectives were: verify the most effective intervention for the prevention of dry eye from the available literature and provided by: eye gel compared to the control group eyedrops who received eye care through randomized controlled clinical trial. Patients and methods: This study is a randomized controlled trial to determine the best care for the prevention of dry eye from those available on the market (eye drops and eye gel), in the period from 14/01/2016 to 31/12/2019 . The expected result is: negative values in Schirmer test and no corneal ulcers presence.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham Comparator: Eye drop | Active Comparator | Eye drop LACRIBELL® - two drops each eye, two times a day, after eye cleansing. |
|
| VIDISIC® GEL | Experimental | Ocular gel VIDISIC® GEL applied two times a day at the lower palpebra from medium line to the lateral border. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LACRIBELL® | Device | Hypromellose and dextran based eyedrop, used in the treatment of dry eye. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dry Eye | Interventions will be applied in both eyes of the patients from 12 to 12 hours for five consecutive days. Schirmer test will be applyed to evaluate the lacrimal volume. Fluorescein test will be applyed to evaluate the ocular surface. | Five consecutive days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diego D Araújo, PhD student | Contact | 55 (38) 3213 2150 | Brazil | diego.dias1508@gmail.com |
| Tânia CM Chianca, PhD | Contact | 55 (31) 3409 9887 | Brazil | taniachianca@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Diego D Araújo, PhD student | State University of Montes Claros, Minas Gerais, Brazil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa de Misericórdia Montes Claros | Recruiting | Montes Claros | Minas Gerais | 39402-218 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27192415 | Background | de Araujo DD, Almeida NG, Silva PM, Ribeiro NS, Werli-Alvarenga A, Chianca TC. Prediction of risk and incidence of dry eye in critical patients. Rev Lat Am Enfermagem. 2016;24:e2689. doi: 10.1590/1518-8345.0897.2689. Epub 2016 May 17. |
Not provided
Not provided
The study and the information provided will be confidential and used only for purposes of this research. Disclosure of information will be anonymous and in conjunction with the responses of a group of people, never individually.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D005128 | Eye Diseases |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| VIDISIC® GEL | Device | Carbomer based gel, used in the treatment of dry eye. |
|
|