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Comparison of Three Different Anesthetic Approaches for Intravitreal Injections

NCT02263690 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2014-10-13

No results posted yet for this study

Summary

92 patients in treatment with intravitreal injections were randomized to 1 of 3 groups: proparacaine 0.5% drops (Group Drops), proparacaine 0.5% drops plus subconjunctival lidocaine (Group SC), or 2% lidocaine gel (Group Gel). Patients were asked to score their pain experience using a visual analogue scale (VAS), a scale of 0 to 10, immediately following the injections as well as 10 minutes, 1 hour, 6 hours and 24 hours after. Patients also graded the overall injection experience as Excellent, Very Good, Fair, Poor or Awful. The physician evaluated the patient's eye movement during intravitreal injection in three levels: none or minimal (0), not compromising the injection (1), compromising the injection (2).

Conditions

Interventions

PROCEDURE

Group Drops

The patients in the group Drops received a drop of proparacaine 0.5% before receiving a peri-ocular drop of povidone iodide 5%. The patients in the group Drops received a second drop of proparacaine 0.5% 5 minutes after the drop of povidone iodide 5%

PROCEDURE

Group SC

The patients in the group SC received a drop of proparacaine 0.5% before receiving a peri-ocular drop of povidone iodide 5%. In the patients in the group SC, a subconjunctival bleb of anesthesia was created by injecting 0,4 mL of lidocaine 1% into the subconjunctival space 4 mm posterior to the superotemporal limbus with a 30-gauge, 1/2-inch needle attached to a 1-mL syringe.

PROCEDURE

Group gel

For the patients in group gel, the gel was placed on the eye before receiving the peri-ocular drop of povidone iodide 5%.

Sponsors & Collaborators

  • Retina Clinic, Sao Paulo, Brazil

    lead OTHER

Principal Investigators

  • Gabriel C Andrade, M.D. · Vitreo-retinal Fellow

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02263690 on ClinicalTrials.gov