Trial Outcomes & Findings for Axial Length and Central Corneal Thickness in Benign Intracranial Hypertension (NCT NCT02541994)

Results Overview

The length of the eye will be measured with ultrasound.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

Single measurement during ultrasound procedure on the day of enrollment in the study on average of 5 minutes.

Results posted on

2024-03-06

Participant milestones
Measure	Ultrasound Testing Single arm with all patients getting measurements of axial length and central corneal thickness. Pachette3: Central corneal thickness will be measured with an ultrasound probe. This test will be performed while the corneas are anesthetized. This test will be performed as part of a standard, comprehensive dilated eye examination with optical coherence tomography and visual field testing as the regular care for benign intracranial hypertension. Lenstar-Think: Axial length will be measured with an ultrasound probe. This test will be performed while the corneas are anesthetized. This test will be performed as part of a standard, comprehensive dilated eye examination with optical coherence tomography and visual field testing as the regular care for benign intracranial hypertension.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Axial Length and Central Corneal Thickness in Benign Intracranial Hypertension

Baseline characteristics by cohort
Measure	Ultrasound Testing n=5 Participants Single arm with all patients getting measurements of axial length and central corneal thickness. Pachette3: Central corneal thickness will be measured with an ultrasound probe. This test will be performed while the corneas are anesthetized. This test will be performed as part of a standard, comprehensive dilated eye examination with optical coherence tomography and visual field testing as the regular care for benign intracranial hypertension. Lenstar-Think: Axial length will be measured with an ultrasound probe. This test will be performed while the corneas are anesthetized. This test will be performed as part of a standard, comprehensive dilated eye examination with optical coherence tomography and visual field testing as the regular care for benign intracranial hypertension.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	35.6 years STANDARD_DEVIATION 7.92 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	5 Participants n=5 Participants

Timeframe: Single measurement during ultrasound procedure on the day of enrollment in the study on average of 5 minutes.

The length of the eye will be measured with ultrasound.

Outcome measures
Measure	Ultrasound Testing n=5 Participants Single arm with all patients getting measurements of axial length and central corneal thickness. Pachette3: Central corneal thickness will be measured with an ultrasound probe. This test will be performed while the corneas are anesthetized. This test will be performed as part of a standard, comprehensive dilated eye examination with optical coherence tomography and visual field testing as the regular care for benign intracranial hypertension. Lenstar-Think: Axial length will be measured with an ultrasound probe. This test will be performed while the corneas are anesthetized. This test will be performed as part of a standard, comprehensive dilated eye examination with optical coherence tomography and visual field testing as the regular care for benign intracranial hypertension.
Axial Length	23.67 millimeter Standard Deviation 1.31

Timeframe: Single measurement during ultrasound procedure at the time of enrollment in the study on average of 5 minutes.

Population: 10 eyes

The thickness of the cornea will be measured with ultrasound.

Outcome measures
Measure	Ultrasound Testing n=5 Participants Single arm with all patients getting measurements of axial length and central corneal thickness. Pachette3: Central corneal thickness will be measured with an ultrasound probe. This test will be performed while the corneas are anesthetized. This test will be performed as part of a standard, comprehensive dilated eye examination with optical coherence tomography and visual field testing as the regular care for benign intracranial hypertension. Lenstar-Think: Axial length will be measured with an ultrasound probe. This test will be performed while the corneas are anesthetized. This test will be performed as part of a standard, comprehensive dilated eye examination with optical coherence tomography and visual field testing as the regular care for benign intracranial hypertension.
Central Corneal Thickness	556.3 Microns Standard Deviation 26.9

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

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