Trial Outcomes & Findings for Pilot Study: A Randomized Trial Of Anesthetic Agents For Intravitreal Injection (NCT NCT00769392)

NCT ID: NCT00769392

Last Updated: 2020-03-09

Results Overview

Discomfort Associated With the Intravitreal Injection using a Subjective Analog Pain Scale (0-10); no pain (0) and severe pain (10)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 28 participants
• Primary outcome timeframe: 16 weeks
• Results posted on: 2020-03-09

Participant Flow

28 participants enrolled in this study. Once 24 subjects completed the study, the remaining 4 subjects were not required to complete the study, therefore, their data was not collected for this analysis.

Participant milestones

Measure	All Study Participants All participants received, in an randomized cross-over fashion, Proparacaine drops, Tetracaine drops, Lidocaine 4% soaked cotton sponge, and Lidocaine 2% subconjunctival injection.
Overall Study STARTED	28
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study: A Randomized Trial Of Anesthetic Agents For Intravitreal Injection

Baseline characteristics by cohort

Measure	All Participants n=24 Participants Participants will be randomized to receive a unique sequence of one of the 4 anesthetic agents per month, prior to a standard of care monthly intravitreal injection (1 injection per month for a total of 4 months). At the end of study participation, each patient will have received each of the 4 anesthetic agents once prior to one of the 4 intravitreal injections (ex. Randomization to sequence: Proparcacaine used prior to Injection 1; Tetracaine used prior to Injection 2; Lidocaine sponge used prior to Injection 3; Lidocaine suconjunctival injection used prior to Injection 4).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	24 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

Discomfort Associated With the Intravitreal Injection using a Subjective Analog Pain Scale (0-10); no pain (0) and severe pain (10)

Outcome measures

Measure	All Participants n=24 Participants Participants will be randomized to receive a unique sequence of one of the 4 anesthetic agents per month, prior to a standard of care monthly intravitreal injection (1 injection per month for a total of 4 months). At the end of study participation, each patient will have received each of the 4 anesthetic agents once prior to one of the 4 intravitreal injections (ex. Randomization to sequence: Proparcacaine used prior to Injection 1; Tetracaine used prior to Injection 2; Lidocaine sponge used prior to Injection 3; Lidocaine suconjunctival injection used prior to Injection 4).
Discomfort Associated With the Intravitreal Injection Lidocaine 4%	3 units on a scale Interval 0.0 to 9.0
Discomfort Associated With the Intravitreal Injection Lidocaine 2% Injectable Solution	2.3 units on a scale Interval 0.0 to 6.0
Discomfort Associated With the Intravitreal Injection Proparacaine Ophthalmic	2.8 units on a scale Interval 0.0 to 8.0
Discomfort Associated With the Intravitreal Injection Tetracaine Ophthalmic	3.1 units on a scale Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: 16 weeks

Discomfort from Anesthesia used prior to Intravitreal Injections using a Subjective Analog Pain Scale (0-10); no pain (0) and severe pain (10).

Outcome measures

Measure	All Participants n=24 Participants Participants will be randomized to receive a unique sequence of one of the 4 anesthetic agents per month, prior to a standard of care monthly intravitreal injection (1 injection per month for a total of 4 months). At the end of study participation, each patient will have received each of the 4 anesthetic agents once prior to one of the 4 intravitreal injections (ex. Randomization to sequence: Proparcacaine used prior to Injection 1; Tetracaine used prior to Injection 2; Lidocaine sponge used prior to Injection 3; Lidocaine suconjunctival injection used prior to Injection 4).
Discomfort From Anesthesia Used Prior to Intravitreal Injections Lidocaine 4%	1.4 units on a scale Interval 0.0 to 8.0
Discomfort From Anesthesia Used Prior to Intravitreal Injections Lidocaine 2% Injectable Solution	1.6 units on a scale Interval 0.0 to 6.0
Discomfort From Anesthesia Used Prior to Intravitreal Injections Proparacaine Ophthalmic	0.7 units on a scale Interval 0.0 to 8.0
Discomfort From Anesthesia Used Prior to Intravitreal Injections Tetracaine Ophthalmic	1.0 units on a scale Interval 0.0 to 4.0

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

All Participants n=24 participants at risk Participants will be randomized to receive a unique sequence of one of the 4 anesthetic agents per month, prior to a standard of care monthly intravitreal injection (1 injection per month for a total of 4 months). At the end of study participation, each patient will have received each of the 4 anesthetic agents once prior to one of the 4 intravitreal injections (ex. Randomization to sequence: Proparcacaine used prior to Injection 1; Tetracaine used prior to Injection 2; Lidocaine sponge used prior to Injection 3; Lidocaine suconjunctival injection used prior to Injection 4).

Eye disorders Subconjunctival Hemorrage with Lidocaine subconjunctival injection

54.2% 13/24 • Number of events 13 • Adverse Event frequency was monitored from the time of participant consent to the end of the study at 6 months.

Additional Information

Gregory Blaha, MD

Lahey Clinic

Phone: 781-744-2580

Email: christine.gould@lahey.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place