Characterization and Causative Factors of Negative Dysphotopsia

Pseudoaphakia Clinical Trial

— NDys  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04224129
• Other study ID #: NDys
• Status: Recruiting
• Start date: January 2016
• Est. completion date: May 2021

Study information

• Verified date: January 2020
• Source: Vienna Institute for Research in Ocular Surgery
• Contact: Oliver Findl, MD, Prof.
• Phone: 004319102157564
• Email: office[@]viros.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Pseudoaphakia

Locations

Country	Name	City	State
Austria	Hanusch-Krankenhaus	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Vienna Institute for Research in Ocular Surgery

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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