Trial Outcomes & Findings for Wearing-Off Period of Pharmacological Dilation and Anisocoria (NCT NCT05238233)

Results Overview

Measurement of pupil diameter

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

11 participants

Primary outcome timeframe

4 hours

Results posted on

2023-03-07

Participant Flow

Unit of analysis: Eye

Participant milestones

Participant milestones
Measure	Eye Dilation and Constriction - Left Eye 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. Tropicamide: One drop will be given to participants 1% Pilocarpine: One drop will be given to participants Proparacaine Hydrochloride: One drop will be given to participants Tono pen AVIA: Participant intraocular pressures measured VG4 Gonio: Participant iridocorneal angle measured Reichert phoropter: Participant screened for hyperopia \>+1 diopter	Eye Dilation and Constriction - Right Eye 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. Tropicamide: One drop will be given to participants 1% Pilocarpine: One drop will be given to participants Proparacaine Hydrochloride: One drop will be given to participants Tono pen AVIA: Participant intraocular pressures measured VG4 Gonio: Participant iridocorneal angle measured Reichert phoropter: Participant screened for hyperopia \>+1 diopter
Overall Study STARTED	11 11	0 0
Overall Study COMPLETED	10 10	0 0
Overall Study NOT COMPLETED	1 1	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Eye Dilation and Constriction n=11 Participants 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. Tropicamide: One drop will be given to participants 1% Pilocarpine: One drop will be given to participants Proparacaine Hydrochloride: One drop will be given to participants Tono pen AVIA: Participant intraocular pressures measured VG4 Gonio: Participant iridocorneal angle measured Reichert phoropter: Participant screened for hyperopia \>+1 diopter
Age, Categorical <=18 years	0 Participants n=11 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=11 Participants
Age, Categorical >=65 years	0 Participants n=11 Participants
Sex: Female, Male Female	2 Participants n=11 Participants
Sex: Female, Male Male	9 Participants n=11 Participants

PRIMARY outcome

Timeframe: 4 hours

Measurement of pupil diameter

Outcome measures

Outcome measures
Measure	Eye Dilation and Constriction n=10 Participants 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. Tropicamide: One drop will be given to participants 1% Pilocarpine: One drop will be given to participants Proparacaine Hydrochloride: One drop will be given to participants Tono pen AVIA: Participant intraocular pressures measured VG4 Gonio: Participant iridocorneal angle measured Reichert phoropter: Participant screened for hyperopia \>+1 diopter
Number of Participants With Constricting Response to Pilocarpine 1% in the Pharmacologically Dilated Eye	3 Participants

Adverse Events

Eye Dilation and Constriction

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Aimee Hanvey

Prisma Health

Phone: 864-760-7350

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place