NCT01477996

Brief Summary

This randomized clinical trial is comparing two different needles (27 gauge versus 30 gauge) for intravitreal therapy (IVT). Standardized questionnaires and pain scales should allow for standard recommendation regarding the optimal needle size for IVT.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Aug 2011

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 23, 2011

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 26, 2016

Status Verified

November 1, 2011

Enrollment Period

4 months

First QC Date

August 8, 2011

Last Update Submit

January 24, 2016

Conditions

Pain

Keywords

intravitreal therapypain scalesgaugePain ScoresVisual Analog Scale

Outcome Measures

Primary Outcomes (1)

  • Visual Analoge Scale

    pain scores on the visual analog scale after the IVT

    1 day, after the intravitreal therapy (IVT)

Secondary Outcomes (2)

  • patients demographic data

    1 day, record of patients data before or after intravitreal therapy (IVT)

  • Baker scale

    1 day, after the intravitreal therapy (IVT)

Study Arms (2)

Group 1

ACTIVE COMPARATOR

27-gauge needle

Procedure: 27-gauge

Group 2

ACTIVE COMPARATOR

30-gauge needle

Procedure: 30-gauge

Interventions

27-gaugePROCEDURE

27-gauge needle for IVT

Group 1
30-gaugePROCEDURE

30-gauge needle for IVT

Group 2

Eligibility Criteria

Age51 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • vitrearetinal disease including age-related macular degeneration,
  • clinical significant macular edema due to diabetic retinopathy or other vascular disorders
  • treatment with intravitreal therapy

You may not qualify if:

  • missing informed consent
  • age under 50 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery, Department of Ophthalmology; Rudolf Foundation Clinic, Juchgasse 25

Vienna, 1030, Austria

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christiane I Falkner-Radler, MD

    The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

    PRINCIPAL INVESTIGATOR

  • Susanne Binder, MD

    The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principial investigator

Study Record Dates

First Submitted

August 8, 2011

First Posted

November 23, 2011

Study Start

August 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 26, 2016

Record last verified: 2011-11

Locations

AU(1)