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Trial record 63 of 81 for:    CRVO - Central Retinal Vein Occlusion

Anesthesia Preference for Intravitreal Injection: Topical or Subconjunctival

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ClinicalTrials.gov Identifier: NCT01640171
Recruitment Status : Completed
First Posted : July 13, 2012
Results First Posted : April 21, 2014
Last Update Posted : April 21, 2014
Sponsor:
Information provided by (Responsible Party):
Steven Cohen, MD, Retina Vitreous Associates of Florida

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Age-related Macular Degeneration
Central Retinal Vein Occlusion
Diabetic Macular Edema
Interventions Procedure: Xylocaine 2% Injectable Anesthetic
Drug: Proparacaine Hydrochloride 0.5% Drop
Drug: Tetravisc 0.5% Gel
Drug: Acuvail
Drug: Intra-vitreal Anti-VEGF Drug
Enrollment 57
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Topical Anesthesia 1 Eye, SC 1 Eye
Hide Arm/Group Description

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

Period Title: Overall Study
Started 57
Completed 57
Not Completed 0
Arm/Group Title Topical Anesthesia 1 Eye, SC 1 Eye
Hide Arm/Group Description

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

Overall Number of Baseline Participants 57
Hide Baseline Analysis Population Description
57 patients were treated differently in each eye.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 57 participants
82  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants
Female
37
  64.9%
Male
20
  35.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 57 participants
57
1.Primary Outcome
Title Number of Participants Who Preferred Subconjunctival Anesthetic at the Third Follow-up Visit
Hide Description 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.
Time Frame up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topical Anesthesia 1 Eye, SC 1 Eye
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: participants
50
2.Secondary Outcome
Title Number of Participatns With Level 10 Pain on Wong-Baker Pain Scale In Subconjunctival Eye At Time of Intravitreal Injection
Hide Description 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.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in the study
Arm/Group Title Topical Anesthesia 1 Eye, SC 1 Eye
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: participants
0
3.Secondary Outcome
Title Likert Like Pain Scale Number of Participants Who Said the Topical Eye Hurt Much More Than the Subconjunctival Eye at Time of Intravitreal Injection
Hide Description 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).
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
total group
Arm/Group Title Topical Anesthesia 1 Eye, SC 1 Eye
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: participants
19
Time Frame 1 year
Adverse Event Reporting Description Patients were followed for a total of one year
 
Arm/Group Title Topical Anesthesia Subconjunctival Anesthesia
Hide Arm/Group Description

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

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

All-Cause Mortality
Topical Anesthesia Subconjunctival Anesthesia
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Topical Anesthesia Subconjunctival Anesthesia
Affected / at Risk (%) Affected / at Risk (%)
Total   0/57 (0.00%)   0/57 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Topical Anesthesia Subconjunctival Anesthesia
Affected / at Risk (%) Affected / at Risk (%)
Total   0/57 (0.00%)   0/57 (0.00%) 
Most patients were treated with subconjunctival anesthetic prior to the study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Steven Cohen
Organization: Retina Vitreous Associates of Florida
Phone: 7274459110
Responsible Party: Steven Cohen, MD, Retina Vitreous Associates of Florida
ClinicalTrials.gov Identifier: NCT01640171     History of Changes
Other Study ID Numbers: rvaf-2012
First Submitted: July 11, 2012
First Posted: July 13, 2012
Results First Submitted: November 30, 2013
Results First Posted: April 21, 2014
Last Update Posted: April 21, 2014