Trial Outcomes & Findings for Anesthesia Preference for Intravitreal Injection: Topical or Subconjunctival (NCT NCT01640171)

Results Overview

Participants received anesthetic over several treatment visits. They were allowed to change there preference at each visit. The final outcome was the preference indicated at the third follow-up visit.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

57 participants

Primary outcome timeframe

up to 6 months

Results posted on

2014-04-21

Participant Flow

Participant milestones

Participant milestones
Measure	Topical Anesthesia 1 Eye, SC 1 Eye Eye receiving only topical gel Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye. Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment Acuvail: Anti-inflammatory drop given after treatment Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion Fellow eye Same as above plus Xylocaine 2% SC
Overall Study STARTED	57
Overall Study COMPLETED	57
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Anesthesia Preference for Intravitreal Injection: Topical or Subconjunctival

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Topical Anesthesia 1 Eye, SC 1 Eye n=57 Participants Eye receiving only topical gel Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye. Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment Acuvail: Anti-inflammatory drop given after treatment Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion Fellow Eye: Eye receiving topical gel and subconjunctival lidocaine Xylocaine 2% Injectable Anesthetic: xylocaine 2% injection 0.1 cc Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye. Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment Acuvail: Anti-inflammatory drop given after treatment Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion
Age, Continuous	82 years STANDARD_DEVIATION 11 • n=99 Participants
Sex: Female, Male Female	37 Participants n=99 Participants
Sex: Female, Male Male	20 Participants n=99 Participants
Region of Enrollment United States	57 participants n=99 Participants

PRIMARY outcome

Timeframe: up to 6 months

Participants received anesthetic over several treatment visits. They were allowed to change there preference at each visit. The final outcome was the preference indicated at the third follow-up visit.

Outcome measures

Outcome measures
Measure	Topical Anesthesia 1 Eye, SC 1 Eye n=57 Participants Eye receiving only topical gel Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye. Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment at three minute intervals Acuvail: Anti-inflammatory drop given after treatment Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion Fellow eye: Same as above plus SC Xylocaine was administered following the first two topical anesthetic applications
Number of Participants Who Preferred Subconjunctival Anesthetic at the Third Follow-up Visit	50 participants

SECONDARY outcome

Timeframe: 24 hours

Population: All patients in the study

Pain was rated on a 10 point standardized pain scale, zero was the least pain and 10 was the worst pain. The patient was questioned using a script and shown a pain scale as well as told how the pain scale worked. Then the patient gave the number that characterized their pain.

Outcome measures

Outcome measures
Measure	Topical Anesthesia 1 Eye, SC 1 Eye n=57 Participants Eye receiving only topical gel Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye. Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment at three minute intervals Acuvail: Anti-inflammatory drop given after treatment Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion Fellow eye: Same as above plus SC Xylocaine was administered following the first two topical anesthetic applications
Number of Participatns With Level 10 Pain on Wong-Baker Pain Scale In Subconjunctival Eye At Time of Intravitreal Injection	0 participants

SECONDARY outcome

Timeframe: 24 hours

Population: total group

The patient was asked to compare the two eyes in the way described in the study protocol on a five point scale. If one eye hurt a lot more or a little more than the other or if the two eyes were equal (neither hurt more than the other).

Outcome measures

Outcome measures
Measure	Topical Anesthesia 1 Eye, SC 1 Eye n=57 Participants Eye receiving only topical gel Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye. Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment at three minute intervals Acuvail: Anti-inflammatory drop given after treatment Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion Fellow eye: Same as above plus SC Xylocaine was administered following the first two topical anesthetic applications
Likert Like Pain Scale Number of Participants Who Said the Topical Eye Hurt Much More Than the Subconjunctival Eye at Time of Intravitreal Injection	19 participants

Adverse Events

Topical Anesthesia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Subconjunctival Anesthesia

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

Steven Cohen

Retina Vitreous Associates of Florida

Phone: 7274459110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place