NCT04224129

Brief Summary

The present study is designed as an exploratory study, seeking to investigate the correlation of patient complaints to subjective or objective measurement methods. Better understanding of causative factors of negative dysphotopsia will improve detection and maybe prediction of this optical phenomenon.

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
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2017

Completed
2.8 years until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

4.9 years

First QC Date

April 11, 2017

Last Update Submit

January 7, 2020

Conditions

Pseudoaphakia

Outcome Measures

Primary Outcomes (1)

  • Identification of factors or a combination thereof that may cause negative dysphotopsia

    Biometry, Anamnesis, visual field, psychological questionnaires, wavefront aberrometry will be used to analyse if a factor causative for negative dysphotopsia can be detected

    2 hours

Secondary Outcomes (2)

  • Method to standardize characterization of negative dysphotopsia

    20 minutes

  • Correlation between eye biometry, patient complaints and psychophysics

    30 minutes

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

10 patients after cataract extraction, suffering from negative dysphotopsia

You may qualify if:

  • Pseudophakic
  • Recurrently and persistently reporting about negative dysphotopsia
  • Age 21 and older
  • written informed consent prior to entering the study

You may not qualify if:

  • Relevant ophthalmic diseases such as: glaucoma, (previous) traumatic cataract, corneal scars, age-related macular degeneration and other pathologies resulting in visual field defects
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanusch-Krankenhaus

Vienna, A-1140, Austria

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Oliver Findl, MD, Prof.

    Vienna Institute for Research in Ocular Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oliver Findl, MD, Prof.

CONTACT

004319102157564office@viros.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 11, 2017

First Posted

January 13, 2020

Study Start

January 1, 2016

Primary Completion

December 1, 2020

Study Completion

May 1, 2021

Last Updated

January 13, 2020

Record last verified: 2020-01

Locations

AU(1)