Cataract SurgeryNCT01181752
Proficiency of Eye Drop Instillation in Postoperative Cataract Patients in Ghana
An observational study of Cataract Surgery, run by University of British Columbia at 1 site in Ghana.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract Surgery
- How many people
- 300 participants
- Where
- 1 siteGhana
- Study dates
- Feb 2012to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People in Ghana needing proficiency of eye drop instillation in postoperative cataract surgery
Who may be able to join
- 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).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Ghana1 site
Crystal Eye Clinic, Adenta Housing, No. 5 Giner Close
Accra-North
Yang (Linda) Liu, 778-868-7283, linda008@interchange.ubc.ca
About this study
Official title: Educational Intervention, Observing Participants' Proficiency of Eye Drop Instillation
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.
Read more
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.
Read the 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.
- Conditions
- Cataract Surgery
- Keywords
- proficiency, eye drop instillation, postoperative cataract surgery, Ghana
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (1)
Irritation or pain after surgery
The secondary end-point is whether subjects feel irritation or pain after surgery. This will be measured on postoperative day 30.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study startFeb 2012
- Primary completionDec 2012 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SurgeryStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shafik Dharamsi, Ph.D, Principal investigator, University of British ColumbiaAnnalee Yassi, Dr., Study director, University of British ColumbiaJerry Spiegel, Dr., Study director, University of British ColumbiaKen Bassett, Dr., Study director, University of British ColumbiaYang Liu, Dr., Study director, University of British ColumbiaChristian Peoples, Dr., Study director, University of British ColumbiaTiffany Shiau, Dr., Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181752
- Sponsor's protocol ID
- H10-01479
- Status last verified
- Feb 2012
- First submitted
- 11 Aug 2010
- Last updated
- 1 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Intervention, Observing Participants' Proficiency of Eye Drop Instillation
- ClinicalTrials.gov ID
- NCT01181752
- Acronym / sponsor ID
- H10-01479
- Conditions
- Cataract Surgery
- Keywords
- proficiency, eye drop instillation, postoperative cataract surgery, Ghana
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 13 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People in Ghana needing proficiency of eye drop instillation in postoperative cataract surgery
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Instillation of one drop of Dexatrol into the eye
Time frame: 30 days
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.
1 secondary outcome
Irritation or pain after surgery
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shafik Dharamsi, Ph.D principal investigator
University of British Columbia
Annalee Yassi, Dr. study director
University of British Columbia
Jerry Spiegel, Dr. study director
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract Surgery, run by University of British Columbia at 1 site in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang (Linda) Liu (778-868-7283, linda008@interchange.ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Instillation of one drop of Dexatrol into the eye (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2012.