NCT03749759

Brief Summary

Purpose of this study is to find a correlation between agitation (stress) indicating parameters and the pain perception during second eye cataract surgery, compared to first eye cataract surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2017

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

3 years

First QC Date

November 20, 2018

Last Update Submit

February 26, 2019

Conditions

Cataract

Keywords

CataractCataract surgeryBiofeedback

Outcome Measures

Primary Outcomes (1)

  • Perioperative agitation (stress) measurement

    Perioperative stress will be measured using the BioLink Biofeedback device, which records an electrocardiogram, an electromyogram, skin conductance and respiratory rate. Changes in the different values show how stressed the patient was during the surgeries.

    12 months

Secondary Outcomes (1)

  • Assessment of pain perception

    12 months

Study Arms (1)

Biofeedback measurement

EXPERIMENTAL

A Biofeedback measurement will be done during cataract surgery of both eyes

Procedure: Cataract surgery

Interventions

Cataract surgeryPROCEDURE

A biofeedback measurement will be carried out during cataract surgery of both eyes

Biofeedback measurement

Eligibility Criteria

Age21 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 21 and older
  • written informed consent prior to surgery
  • bilateral age-related cataract

You may not qualify if:

  • deafness
  • allergy to topical anesthetic agents
  • severe anxiety and involuntary eye and head movements
  • conditions likely to require surgical therapy other than routine phacoemulsification (eg: traumatic and complicated cataracts)
  • in case of pregnancy (pregnancy test will be taken in women of reproductive age)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vienna Institute for Research in Ocular Surgery (VIROS)

Vienna, 1140, Austria

RECRUITING

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

John Falasinnu, MD

CONTACT

01 91021-57559office@viros.at

Katharina Kefer

CONTACT

01 91021-57564office@viros.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 20, 2018

First Posted

November 21, 2018

Study Start

January 1, 2017

Primary Completion

January 1, 2020

Study Completion

January 1, 2021

Last Updated

February 27, 2019

Record last verified: 2019-02

Locations

AU(1)