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Proficiency of Eye Drop Instillation in Postoperative Cataract Patients in Ghana

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of British Columbia.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01181752
First received: August 11, 2010
Last updated: February 28, 2012
Last verified: February 2012
  Purpose

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.


Condition
Cataract Surgery

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Educational Intervention, Observing Participants' Proficiency of Eye Drop Instillation

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Instillation of one drop of Dexatrol into the eye [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Irritation or pain after surgery [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    The secondary end-point is whether subjects feel irritation or pain after surgery. This will be measured on postoperative day 30.


Estimated Enrollment: 300
Study Start Date: February 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group A
Baseline/control subjects who are only tested on postoperative day 30
Group B
Subjects who will be tested on postoperative day 1 and day 30
Group C
Subjects who cannot proficiently administer the medication on postoperative day 1 will be re-classified as "Group C" subjects

Detailed Description:

Purpose:

To determine the number of subjects who can proficiently administer one drop of Dexatrol (the steroidal anti-inflammatory drug that Crystal Eye Clinic staff provide to all patients who undergo cataract surgery) on their first attempt on postoperative day 1 and compare this to the number of subjects who can proficiently administer one drop of Dexatrol into the eye that received cataract surgery after using the medication for 30 days.

Baseline/control subjects who are only tested on postoperative day 30 will be referred to as "Group A" subjects. Subjects who will be tested on postoperative day 1 and 30 will be referred to as "Group B" subjects. If "Group B" subjects can proficiently administer the medication on postoperative day 1, they will remain in "Group B" and researchers will determine their rate of success again on postoperative day 30. If subjects cannot proficiently administer the medication on postoperative day 1, they will be re-classified as "Group C" subjects and researchers will determine whether an educational session regarding the correct instillation of eye drops will improve the proficiency of these subjects when they are tested again on postoperative day 30. This will allow staff at Crystal Eye Clinic to understand the effectiveness of their current educational session and will determine the efficacy of an additional educational session. Researchers will also use questionnaires to determine if there are factors that affect the ability of subjects to properly instill the medication as well as if the proficiency of instillation correlates to whether patients experienced irritation or pain before or on postoperative day 30. Dexatrol will not be used outside of its approved indication.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

People in Ghana needing proficiency of eye drop instillation in postoperative cataract surgery

Criteria

Inclusion Criteria:

  • Patients who receive cataract surgery sponsored by Unite For Sight from Crystal Eye Clinic from August 20, 2010 to October 2010.
  • Patients who had surgery prior to August 20 and will have their postoperative 30 day check up between August 20 and October 20 will be eligible to be Group A subjects.
  • Participants must be over 19 and capable of understanding the purpose of the study, risks/benefits involved and all other information needed to provide informed consent.
  • Participants must be able to follow instructions (those outlined in the proposal i.e. apply one drop of eye solution into the eye that was operated on).
  • Participants must be able to answer the questionnaire either verbally or through writing (with or without the aid of an interpreter).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01181752

Contacts
Contact: Yang (Linda) Liu 778-868-7283 linda008@interchange.ubc.ca

Locations
Ghana
Crystal Eye Clinic, Adenta Housing, No. 5 Giner Close Not yet recruiting
Accra-North, Ghana
Contact: Yang (Linda) Liu    778-868-7283    linda008@interchange.ubc.ca   
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Shafik Dharamsi, Ph.D University of British Columbia
Study Director: Annalee Yassi, Dr. University of British Columbia
Study Director: Jerry Spiegel, Dr. University of British Columbia
Study Director: Ken Bassett, Dr. University of British Columbia
Study Director: Yang Liu, Dr. University of British Columbia
Study Director: Christian Peoples, Dr. University of British Columbia
Study Director: Tiffany Shiau, Dr. University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01181752     History of Changes
Other Study ID Numbers: H10-01479
Study First Received: August 11, 2010
Last Updated: February 28, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
proficiency
eye drop instillation
postoperative cataract surgery
Ghana

Additional relevant MeSH terms:
Cataract
Eye Diseases
Lens Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014