Characterization and Causative Factors of Negative Dysphotopsia (NDys)

Defining and Quantifying Negative Dysphotopsia Characterization and Causative Factors of Negative Dysphotopsia

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.

Study Overview

• Status: Unknown
• Conditions: Pseudoaphakia

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, A-1140
    • Recruiting
    • Hanusch-Krankenhaus
    • Contact: Oliver Findl, MD, MBA; Phone Number: +431 910 21 84611; Email: oliver@findl.at
    • Principal Investigator: Oliver Findl, MD, MBA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

10 patients after cataract extraction, suffering from negative dysphotopsia

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Method to standardize characterization of negative dysphotopsia	New approaches like Goldmann visual field are used to try to picture negative dysphotopsias and patients will also be asked to draw the "dark shadows"	20 minutes
Correlation between eye biometry, patient complaints and psychophysics	Eye biometry will be measured using IOL Master 700, patient complaints will be asked during an patient-doctor interview, and psychophysics will be assessed using a psychological questionnaire	30 minutes

Collaborators and Investigators

• Sponsor: Vienna Institute for Research in Ocular Surgery

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): May 1, 2021

Study Registration Dates

• First Submitted: April 11, 2017
• First Submitted That Met QC Criteria: January 7, 2020
• First Posted (ACTUAL): January 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 7, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: NDys