GlaucomaPAVENCT00338208
Adult Providing Access to the Visual Environment (PAVE) - Glaucoma Pilot
A study testing Training in the Use of Low Vision Devices in people with Glaucoma, run by Vanderbilt University at 1 site in United States.
Trial summary
We wish to evaluate a potential training program for patients with glaucoma, to become more efficient users of prescribed low vision devices for distance and near vision tasks. We hypothesize that the devices will improve efficiency. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Training in the Use of Low Vision Devices
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Dec 2011
- Phase
- Interventional
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Glaucoma patients with vision less than 20/40
Who cannot join
- Subjects must not have any significant physical mobility limitations and be willing to participate in the testing and training sessions.
Trial locations and contacts
1 site in 1 country.
About this study
We wish to evaluate a potential training program for patients with glaucoma, to become more efficient users of prescribed low vision devices for distance and near vision tasks. We hypothesize that the devices will improve efficiency. Prescribed devices will include a stand magnifier, a handheld magnifier, spectacle magnifiers for near vision, and a handheld monocular (telescope) and a bioptic telescope (spectacle-mounted telescope) for distance vision. The success of being able to use optical devices is dependent upon training. Optical devices are currently accepted and used for patients with visual conditions that decrease their central vision. The bioptic telescope is a pair of glasses with a small telescope mounted within the carrier lens. The glasses look and feel like a normal pair of glasses, but have a black device (telescope) protruding from the top of one lens for better identifying distance objects. The spectacle magnifier is mounted in a pair of glasses also for near vision
Read the detailed description
You will be asked a series of oral questions regarding your health status and vision level of functioning (Expectations of Visual Functioning Form, NEI-VFQ, Linear Rating Scale, and Geriatric Depression Scale) in the Vanderbilt Eye Clinic. You will undergo a mobility pre-test to assess your ability to find objects in the distance as well as read . You will undergo a low vision examination in the eye clinic. You will receive the optical devices and then receive brief instructions on the use of the devices . You will then undergo a pre-training evaluation. You will receive approximately 6 training sessions with your prescribed devices for up to 1 hour each time. You will return to the Vanderbilt Eye Clinic for the post-training distance and near vision assessments with the devices . You will be asked the series of oral questions again regarding your health status and vision level of functioning .
- Conditions
- Glaucoma
- Being tested
- Training in the Use of Low Vision Devices
- Keywords
- low vision, glaucoma
- Medical subject headings
- Glaucoma, Vision, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training in the Use of Low Vision DevicesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| No training | No intervention | Subjects will be fitted with low vision devices; no extra training will be provided. |
| Training in the Use of Low Vision Devices | Experimental | Subjects will be fitted with low vision devices and will receive 6 training sessions with prescribed devices for up to 1 hour each time Receives: Behavioral: Training in the Use of Low Vision Devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
mobility
Measured: At time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startOct 2003
- Primary completionDec 2010
- Study completionDec 2011
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Joos, Vanderbilt University
- Investigators
- Karen Joos, MD, PhD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00338208
- Sponsor's protocol ID
- Vanderbilt IRB #030642
- Acronym
- PAVE
- Status last verified
- Aug 2015
- First submitted
- 15 Jun 2006
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adult Providing Access to the Visual Environment (PAVE) - Glaucoma Pilot
- ClinicalTrials.gov ID
- NCT00338208
- Acronym / sponsor ID
- PAVE / Vanderbilt IRB #030642
- Conditions
- Glaucoma
- Keywords
- low vision, glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Oct 2003
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 20 Jun 2006 (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.
We wish to evaluate a potential training program for patients with glaucoma, to become more efficient users of prescribed low vision devices for distance and near vision tasks. We hypothesize that the devices will improve efficiency. Prescribed devices will include a stand magnifier, a handheld magnifier, spectacle magnifiers for near vision, and a handheld monocular (telescope) and a bioptic telescope (spectacle-mounted telescope) for distance vision. The success of being able to use optical devices is dependent upon training. Optical devices are currently accepted and used for patients with visual conditions that decrease their central vision. The bioptic telescope is a pair of glasses with a small telescope mounted within the carrier lens. The glasses look and feel like a normal pair of glasses, but have a black device (telescope) protruding from the top of one lens for better identifying distance objects. The spectacle magnifier is mounted in a pair of glasses also for near vision
Detailed description
You will be asked a series of oral questions regarding your health status and vision level of functioning (Expectations of Visual Functioning Form, NEI-VFQ, Linear Rating Scale, and Geriatric Depression Scale) in the Vanderbilt Eye Clinic. You will undergo a mobility pre-test to assess your ability to find objects in the distance as well as read . You will undergo a low vision examination in the eye clinic. You will receive the optical devices and then receive brief instructions on the use of the devices . You will then undergo a pre-training evaluation. You will receive approximately 6 training sessions with your prescribed devices for up to 1 hour each time. You will return to the Vanderbilt Eye Clinic for the post-training distance and near vision assessments with the devices . You will be asked the series of oral questions again regarding your health status and vision level of functioning .
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No training | No intervention | –Subjects will be fitted with low vision devices; no extra training will be provided. |
| Training in the Use of Low Vision Devices | Experimental | Behavioral: Training in the Use of Low Vision DevicesSubjects will be fitted with low vision devices and will receive 6 training sessions with prescribed devices for up to 1 hour each time |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Glaucoma patients with vision less than 20/40
Key exclusion criteria (1 listed)
- Subjects must not have any significant physical mobility limitations and be willing to participate in the testing and training sessions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training in the Use of Low Vision Devices | Behavioural | Training in the Use of Low Vision Devices |
Primary outcome
mobility
Time frame: At time of enrollment
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 20 Aug 2015.
Related trials for Glaucoma
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
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.
Karen Joos, MD, PhD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in the Use of Low Vision Devices in people with Glaucoma, run by Vanderbilt University 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 1 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 20 Aug 2015. 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?
mobility (time frame: At time of enrollment). 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 20 Aug 2015.