AnisocoriaPhase 4NCT05238233
Wearing-Off Period of Pharmacological Dilation and Anisocoria
A Phase 4 study testing Tropicamide, 1% Pilocarpine and Proparacaine Hydrochloride in people with Anisocoria, run by Prisma Health-Upstate at 1 site in United States.
Trial summary
Students at the School of Medicine Greenville will be asked to participate in this study. The aim of this study is to better understand when medical imaging is needed for patients with anisocoria (unequal pupil size). Participation in the study includes up to 3 visits over a period of one week. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anisocoria
- What is being tested?
- Tropicamide, 1% Pilocarpine and Proparacaine Hydrochloride
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 17 Jan 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Student at the University of South Carolina School of Medicine Greenville
- Healthy participants
- No significant ophthalmological history
Who cannot join
- a history of angle closure glaucoma, any other type of glaucoma
- any elevated eye pressure readings
- any history of intraocular surgery or procedure.
- if the participant is found to be hyperopic to >+1 diopter, has an intraocular pressure of > 22 mm Hg in either eye, or displays an iridocorneal angle where trabecular meshwork
- known allergy to natural rubber latex
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Wearing-Off Period of Pharmacological Dilation: An Addendum to the Management of Anisocoria
Students at the School of Medicine Greenville will be asked to participate in this study.
The aim of this study is to better understand when medical imaging is needed for patients with anisocoria (unequal pupil size).
Read more
Participation in the study includes up to 3 visits over a period of one week. Each study visit will last about 30 minutes.
At the first visit, participants will be screened for hyperopia using a phoropter, have their intraocular pressures taken using a tono-pen, and have their iridocorneal angle measured using gonioscopy at the ophthalmology clinic. Proparacaine hydrochloride 0.5% eye drops will be used to numb the eyes before measuring intraocular pressures and prior to gonio lens exam. Participants will also be asked to complete three forms.
Participants will be asked to return to the clinic on a scheduled day within one week of the screening visit to have their left eye dilated. At this visit, the diameter of the pupil will be measured using a Near card in a windowless room with a set light-level. Then, the participant will receive one drop of tropicamide in the left eye. After the drops have had time to take effect, which will be about 20-30 minutes later, the diameter of the pupil will be measured again.
Participants will then be asked to return to the clinic in 3-4 hours. At this time, the diameter of the pupil will be measured again.
The third type of eye drop used in this study is 1% pilocarpine. 1 % pilocarpine will briefly constrict the eyes. One drop of 1% pilocarpine will be administered to left eye, and the change in pupillary diameter will be measured, if any. It will take about 10-15 minutes for the 1% pilocarpine to take effect.
Participants may be required to attend 2 additional 30-minute visits on a third day depending on how their eyes respond to the drops.
This study will recruit about 10-15 participants.
- Conditions
- Anisocoria
- Being tested
- Tropicamide, 1% Pilocarpine, Proparacaine Hydrochloride, Tono pen AVIA, VG4 Gonio
- Medical subject headings
- Anisocoria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TropicamideDrug
One drop will be given to participants
1% PilocarpineDrug
One drop will be given to participants
Proparacaine HydrochlorideDrug
One drop will be given to participants
Tono pen AVIADevice
Participant intraocular pressures measured
VG4 GonioDevice
Participant iridocorneal angle measured
Reichert phoropterDevice
Participant screened for hyperopia >+1 diopter
| Study group | Role | What they receive |
|---|---|---|
| Eye Dilation and Constriction | Experimental | Participants screened for hyperopia >+1 diopter using a phoropter, have their intraocular pressures measured using a tono pen, and have their iridocorneal angle measured with a gonio lens.
Proparacaine hydrochloride 0.5% eye drops will be used to numb the eyes before measuring intraocular pressures and prior to gonio lens.
The following day, the participant will receive one drop of tropicamide and one drop of 1% pilocarpine in the left eye.
If the left eye has no response to the 1% pilocarpine, or if the diameter of the pupil returned to baseline size, we will ask participants to come back to the clinic on another day to have the process repeated in the right eye. Receives: Drug: Tropicamide; Drug: 1% Pilocarpine; Drug: Proparacaine Hydrochloride; Device: Tono pen AVIA; Device: VG4 Gonio; Device: Reichert phoropter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Constricting Response to Pilocarpine 1% in the Pharmacologically Dilated Eye
Measurement of pupil diameter
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start1 Apr 2022
- Primary completion17 Jan 2023
- Study completion17 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnisocoriaStudies 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 4
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238233
- Sponsor's protocol ID
- 1864081
- Status last verified
- Jan 2023
- First submitted
- 3 Feb 2022
- Last updated
- 7 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Wearing-Off Period of Pharmacological Dilation: An Addendum to the Management of Anisocoria
- ClinicalTrials.gov ID
- NCT05238233
- Acronym / sponsor ID
- 1864081
- Conditions
- Anisocoria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 17 Jan 2023 (actual)
- Study completion
- 17 Jan 2023 (actual)
- First posted
- 14 Feb 2022 (actual)
- Results
- Posted 7 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Students at the School of Medicine Greenville will be asked to participate in this study.
The aim of this study is to better understand when medical imaging is needed for patients with anisocoria (unequal pupil size).
Participation in the study includes up to 3 visits over a period of one week. Each study visit will last about 30 minutes.
At the first visit, participants will be screened for hyperopia using a phoropter, have their intraocular pressures taken using a tono-pen, and have their iridocorneal angle measured using gonioscopy at the ophthalmology clinic. Proparacaine hydrochloride 0.5% eye drops will be used to numb the eyes before measuring intraocular pressures and prior to gonio lens exam. Participants will also be asked to complete three forms.
Participants will be asked to return to the clinic on a scheduled day within one week of the screening visit to have their left eye dilated. At this visit, the diameter of the pupil will be measured using a Near card in a windowless room with a set light-level. Then, the participant will receive one drop of tropicamide in the left eye. After the drops have had time to take effect, which will be about 20-30 minutes later, the diameter of the pupil will be measured again.
Participants will then be asked to return to the clinic in 3-4 hours. At this time, the diameter of the pupil will be measured again.
The third type of eye drop used in this study is 1% pilocarpine. 1 % pilocarpine will briefly constrict the eyes. One drop of 1% pilocarpine will be administered to left eye, and the change in pupillary diameter will be measured, if any. It will take about 10-15 minutes for the 1% pilocarpine to take effect.
Participants may be required to attend 2 additional 30-minute visits on a third day depending on how their eyes respond to the drops.
This study will recruit about 10-15 participants.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eye Dilation and Constriction | Experimental | Drug: Tropicamide, Drug: 1% Pilocarpine, Drug: Proparacaine Hydrochloride, Device: Tono pen AVIA, Device: VG4 Gonio, Device: Reichert phoropterParticipants screened for hyperopia >+1 diopter using a phoropter, have their intraocular pressures measured using a tono pen, and have their iridocorneal angle measured with a gonio lens. Proparacaine hydrochloride 0.5% eye drops will be used to numb the eyes before measuring intraocular pressures and prior to gonio lens. The following day, the participant will receive one drop of tropicamide and one drop of 1% pilocarpine in the left eye. If the left eye has no response to the 1% pilocarpine, or if the diameter of the pupil returned to baseline size, we will ask participants to come back to the clinic on another day to have the process repeated in the right eye. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Student at the University of South Carolina School of Medicine Greenville
- Healthy participants
- No significant ophthalmological history
Key exclusion criteria (5 listed)
- a history of angle closure glaucoma, any other type of glaucoma
- any elevated eye pressure readings
- any history of intraocular surgery or procedure.
- if the participant is found to be hyperopic to >+1 diopter, has an intraocular pressure of > 22 mm Hg in either eye, or displays an iridocorneal angle where trabecular meshwork
- known allergy to natural rubber latex
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 |
|---|---|---|
| TropicamideOne drop will be given to participants | Drug | Eye Dilation and Constriction |
| 1% PilocarpineOne drop will be given to participants | Drug | Eye Dilation and Constriction |
| Proparacaine HydrochlorideOne drop will be given to participants | Drug | Eye Dilation and Constriction |
| Tono pen AVIAParticipant intraocular pressures measured | Device | Eye Dilation and Constriction |
| VG4 GonioParticipant iridocorneal angle measured | Device | Eye Dilation and Constriction |
| Reichert phoropterParticipant screened for hyperopia >+1 diopter | Device | Eye Dilation and Constriction |
Primary outcome
Number of Participants With Constricting Response to Pilocarpine 1% in the Pharmacologically Dilated Eye
Time frame: 4 hours
Measurement of pupil diameter
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Anisocoria
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Anisocoria
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?
A Phase 4 study testing Tropicamide, 1% Pilocarpine and Proparacaine Hydrochloride in people with Anisocoria, run by Prisma Health-Upstate 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 3 inclusion and 5 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 7 Mar 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Constricting Response to Pilocarpine 1% in the Pharmacologically Dilated Eye (time frame: 4 hours). 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 7 Mar 2023.