GlaucomaNCT00760240
Ability of Patients With Low Vision to Properly Instill Eye Drops
An observational study of Glaucoma and Retinal Pathology, run by Mid-Atlantic Glaucoma Experts at 1 site in United States.
Trial summary
The investigators are interested in seeing how people with low vision (decreased visual acuity or restricted visual fields) instill eye drops into their own eyes. The investigators hypothesis is that this population will have more difficulty with self-instillation of drops than a better-seeing population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Retinal Pathology
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Sep 2009
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients reporting for appointments at outpatients referral practices shared by 2 glaucoma and 3 retina specialists
Who may be able to join
- ETDRS visual acuity 20/60 or worse
Who cannot join
- Unwilling to participate
- Light perception vision
- No light perception vision
Trial locations and contacts
1 site in 1 country.
United States1 site
Glaucoma Specialists/Retina Care Center
Baltimore, Maryland, 21209
About this study
Official title: Objective Evaluation of the Ability of Patients With Decreased Vision or Restricted Visual Fields to Properly Instill Eye Drops
The investigators are interested in seeing how people with low vision (decreased visual acuity or restricted visual fields) instill eye drops into their own eyes. The investigators hypothesis is that this population will have more difficulty with self-instillation of drops than a better-seeing population. The investigators aim to explore whatever factors may be involved in preventing this population from getting prescribed eyedrops into their eyes, whether it is more related to visual field or visual acuity.
Read the detailed description
This is a study that involves a questionnaire that a study participant fills out, detailing their experience with eyedrops (if any), followed by a video recording of them instilling artificial tears into their worse-seeing eye, with their dominant hand. Patients must have visual acuity worse than 20/60 in at least one eye, and/or have a recent visual field that demonstrated Hodapp criteria for Moderate or Severe visual field damage. This is an observational study of how patients with low vision due to either glaucoma or retinal disease instill eyedrops. Each video will be "graded" by the principal investigator for "success" at instilling eyedrops, and patients will be stratified by their visual acuity or visual field, and whether they have a primary diagnosis of glaucoma or retinal disease.
- Conditions
- Glaucoma, Retinal Pathology
- Keywords
- compliance, eyedrop instillation, How patients with low vision due to glaucoma or retinal pathology instill eyedrops into their own eyes.
- Medical subject headings
- Glaucoma, Patient Compliance
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 |
|---|---|---|
| Glaucoma patients | This is a group of patients with restricted visual fields or ETDRS visual acuity of 20/60 or worse | |
| Retina patients | A group of patients with retinal pathology(ARMD, CME, diabetic retinopathy) contributing to their decreased vision. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful instillation of a single eyedrop onto the surface of the eye
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- 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
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mid-Atlantic Glaucoma Experts
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760240
- Sponsor's protocol ID
- SI-08-64
- Status last verified
- Apr 2010
- First submitted
- 25 Sep 2008
- Last updated
- 26 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Evaluation of the Ability of Patients With Decreased Vision or Restricted Visual Fields to Properly Instill Eye Drops
- ClinicalTrials.gov ID
- NCT00760240
- Acronym / sponsor ID
- SI-08-64
- Conditions
- Glaucoma, Retinal Pathology
- Keywords
- compliance, eyedrop instillation, How patients with low vision due to glaucoma or retinal pathology instill eyedrops into their own eyes.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mid-Atlantic Glaucoma ExpertsUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 26 Sep 2008 (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.
The investigators are interested in seeing how people with low vision (decreased visual acuity or restricted visual fields) instill eye drops into their own eyes. The investigators hypothesis is that this population will have more difficulty with self-instillation of drops than a better-seeing population. The investigators aim to explore whatever factors may be involved in preventing this population from getting prescribed eyedrops into their eyes, whether it is more related to visual field or visual acuity.
Detailed description
This is a study that involves a questionnaire that a study participant fills out, detailing their experience with eyedrops (if any), followed by a video recording of them instilling artificial tears into their worse-seeing eye, with their dominant hand. Patients must have visual acuity worse than 20/60 in at least one eye, and/or have a recent visual field that demonstrated Hodapp criteria for Moderate or Severe visual field damage. This is an observational study of how patients with low vision due to either glaucoma or retinal disease instill eyedrops. Each video will be "graded" by the principal investigator for "success" at instilling eyedrops, and patients will be stratified by their visual acuity or visual field, and whether they have a primary diagnosis of glaucoma or retinal disease.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glaucoma patients | – | –This is a group of patients with restricted visual fields or ETDRS visual acuity of 20/60 or worse |
| Retina patients | – | –A group of patients with retinal pathology(ARMD, CME, diabetic retinopathy) contributing to their decreased vision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients reporting for appointments at outpatients referral practices shared by 2 glaucoma and 3 retina specialists
Key inclusion criteria (1 listed)
- ETDRS visual acuity 20/60 or worse
Key exclusion criteria (3 listed)
- Unwilling to participate
- Light perception vision
- No light perception vision
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
Successful instillation of a single eyedrop onto the surface of the eye
Time frame: 2 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Glaucoma and Retinal Pathology, run by Mid-Atlantic Glaucoma Experts at 1 site in United States.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 26 Apr 2010. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful instillation of a single eyedrop onto the surface of the eye (time frame: 2 minutes). 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 26 Apr 2010.