Trial Outcomes & Findings for iCare vs Tonopen vs Goldmann Applanation Post-vitrectomy Surgery (NCT NCT01786954)

Results Overview

The primary outcome is the measurement of intraocular pressure on postoperative day #1 following vitreoretinal surgery.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

68 participants

Primary outcome timeframe

postoperative day #1

Results posted on

2016-05-23

Participant Flow

Participant milestones

Participant milestones
Measure	Sequence 1: Icare Then Goldmann Then Tonopen Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry then Goldmann applanation then Tonopen applanation. Icare rebound tonometry Goldmann applanation Tonopen applanation	Sequence 2: Icare Then Tonopen Then Goldmann Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry then Tonopen applanation then Goldmann applanation. Icare rebound tonometry Tonopen applanation Goldmann applanation
Overall Study STARTED	34	34
Overall Study COMPLETED	34	34
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

iCare vs Tonopen vs Goldmann Applanation Post-vitrectomy Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Icare, Goldmann, Tonopen n=68 Participants Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation. Icare rebound tonometry Tonopen applanation Goldmann applanation
Age, Continuous	63 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Region of Enrollment United States	68 participants n=5 Participants

PRIMARY outcome

Timeframe: postoperative day #1

Population: Of the 68 patients enrolled, only 50 patients who received IOP measurement one day following vitrectomy surgery were analyzed. Those with IOP measurement following non-vitrectomy surgery were subsequently excluded from the analysis.

The primary outcome is the measurement of intraocular pressure on postoperative day #1 following vitreoretinal surgery.

Outcome measures

Outcome measures
Measure	Icare n=50 Participants Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation. Icare rebound tonometry	Tonopen n=50 Participants Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation.	Goldmann n=50 Participants Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation.
Measurement of Intraocular Pressure	15.9 mm Hg Standard Deviation 8.9	16.0 mm Hg Standard Deviation 7.3	16.9 mm Hg Standard Deviation 7.2

SECONDARY outcome

Timeframe: postoperative day #1

Population: Adverse events were analyzed for all enrolled patients, in contrast to IOP measurements, which were only analyzed for the 50 post-vitrectomy patients.

The secondary outcome is the onset of any adverse events related to measurement of intraocular pressure.

Outcome measures

Outcome measures
Measure	Icare n=68 Participants Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation. Icare rebound tonometry	Tonopen n=68 Participants Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation.	Goldmann n=68 Participants Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation.
Adverse Events	0 adverse events	0 adverse events	0 adverse events

Adverse Events

Sequence 1: Icare, Goldmann, Tonopen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sequence 2: Icare, Tonopen, Goldmann

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

Dr Paul Hahn

Duke Eye Center

Phone: 919-684-5631

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place