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Educational Intervention, Observing Participants' Proficiency of Eye Drop Instillation
Sponsor study identifier
observational
300
1 country
1
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Eye drops must be proficiently instilled to prevent infections following cataract surgery. Proficiency is defined as placing a drop on the ocular surface without touching the applicator's tip. Researchers will investigate whether patients can proficiently administer eye drops on the first attempt on the first day after surgeries. If successful, researchers will determine how proficient they are 29 days later. If not, they will be provided with additional educational sessions and tested again 29 days later. Researchers will also determine if the proficiency of instillation correlates to whether patients experience irritation or pain after surgery. Summary Brief Summary Eye drops must be proficiently instilled to prevent infections following cataract surgery. Proficiency is defined as placing a drop on the ocular surface without touching the applicator's tip. Researchers will investigate whether patients can proficiently administer eye drops on the first attempt on the first day after surgeries. If successful, researchers will determine how proficient they are 29 days later. If not, they will be provided with additional educational sessions and tested again 29 days later. Researchers will also determine if the proficiency of instillation correlates to whether patients experience irritation or pain after surgery. Hypotheses: On postoperative day 30, there will be a higher rate of successful eye drop instillation in the group of subjects who receive the educational session compared to the baseline group subjects (subjects only tested on postoperative day 30 rather than both the first day after surgery and postoperative day 30) who will not receive it. In comparing the postoperative day 30 proficiency levels of baseline subjects and subjects who were able to proficiently instill a single eye drop on postoperative day 1, the subjects who were able to proficiently instill a single eye drop on postoperative day 1 will have a higher success rate than the baseline group. The number of subjects who are unable to correctly instill the medication on postoperative day 30 and experienced pain or irritation before or during postoperative day 30 will be higher than the number of subjects who are able to correctly instill the medication on postoperative day 30 and experienced pain or irritation before or during postoperative day 30.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 11, 2010
Actual (reported)August 13, 2010
Actual (reported)February 2012
Date type not reportedThis date has not been verified as actual or estimated.
December 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Instillation of one drop of Dexatrol into the eye
The primary end-point is the proficiency of patients in instilling one drop of Dexatrol into the eye that received surgery. This will be measured at postoperative day 1 and postoperative day 30 for Group B and C subjects and only postoperative day 30 for Group A subjects.
30 days
Irritation or pain after surgery
30 days
Baseline/control subjects who are only tested on postoperative day 30
Subjects who will be tested on postoperative day 1 and day 30
Subjects who cannot proficiently administer the medication on postoperative day 1 will be re-classified as "Group C" subjects
People in Ghana needing proficiency of eye drop instillation in postoperative cataract surgery
Crystal Eye Clinic, Adenta Housing, No. 5 Giner Close
Accra-North, Ghana
Shafik Dharamsi, Ph.D
University of British Columbia
Annalee Yassi, Dr.
University of British Columbia
Jerry Spiegel, Dr.
University of British Columbia
Ken Bassett, Dr.
University of British Columbia
First Submitted
August 11, 2010
First Posted
August 13, 2010
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2012
Estimated (date passed)Contact the study team to confirm eligibility.
Yang Liu, Dr.
University of British Columbia
Christian Peoples, Dr.
University of British Columbia
Tiffany Shiau, Dr.
University of British Columbia
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 1, 2012
Record last verified: 2012-02
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Source: ClinicalTrials.gov.
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