NCT01264653

Brief Summary

The purpose of this study is to study the safety and efficacy of intracameral adrenaline for pupil dilation without topical mydriatics in refractive cataract surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2010

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2010

Completed
11 months 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

July 6, 2012

Status Verified

July 1, 2012

Enrollment Period

1 year

First QC Date

December 20, 2010

Last Update Submit

July 4, 2012

Conditions

Cataract

Keywords

cataract

Outcome Measures

Primary Outcomes (1)

  • Pupil size after intracameral adrenaline

    We would like to evaluate Pupil size dilated with intracameral adrenaline 0.01%

    1day

Secondary Outcomes (1)

  • endothelial cell count

    1month

Study Arms (1)

experimental group,control group

EXPERIMENTAL

Intraocular adrenalin,topical mydriatics, experimental group: Intervention: Procedure:refractive cataract surgery with Intraocular adrenalin, control group:refractive cataract surgery with topical mydriatics

Drug: adrenalin

Interventions

adrenalinDRUG

adrenalin 0.01%

Also known as: adrenaline hydrochloride
experimental group,control group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male and female
  • can read and sign informed consent form；
  • Clinical diagnosis of cataract
  • Cataract density grade II-III according to the Emery-Little system classification system

You may not qualify if:

  • sensitivity to adrenalin；
  • sensitivity to topical mydriatics；
  • any other ocular surgeries；
  • iris abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wenzhou Medical College

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Conditions

Cataract

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Ayong Yu

    Wenzhou Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
A-Yong Yu

Study Record Dates

First Submitted

December 20, 2010

First Posted

December 22, 2010

Study Start

December 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

July 6, 2012

Record last verified: 2012-07

Locations

CN(1)