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Comparing an Intraoperative vs. a Standard Wavefront Device

Primary Purpose

Cataract

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Cataract surgery
Sponsored by
Prim. Prof. Dr. Oliver Findl, MBA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cataract focused on measuring Cataract, Wavefront measurement

Eligibility Criteria

21 Years - 105 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Cataract
  • Age 21 and older
  • Able to understand the patient information
  • Willing to follow the instructions and attend all follow-up visits
  • Willing to sign informed consent prior to surgery

Exclusion Criteria:

  • Relevant other ophthalmic diseases that are likely to reduce the refractive outcome, such as pseudoexfoliation syndrome, traumatic cataract, severe corneal scars
  • Previous ocular surgeries on the study eye
  • Patients who are not able to cooperate, with eccentric fixation or insufficient ability to fixate (tremor, nystagmus)
  • Pregnant or lactating women (pregnancy testing will be performed preoperatively on women of reproductive age)

Sites / Locations

  • Vienna Institute for Research in Ocular Surgery (VIROS)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intraoperative wavefront measurement

Arm Description

Patients will be measured with an intraoperative wavefront device during cataract surgery

Outcomes

Primary Outcome Measures

Wavefront aberration measurements
Measurements of wavefront aberrations using an Hartmann-Shack device will be compared at different time points (pre-, intra-, postoperative).

Secondary Outcome Measures

Full Information

First Posted
November 20, 2018
Last Updated
November 20, 2018
Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
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1. Study Identification

Unique Protocol Identification Number
NCT03749798
Brief Title
Comparing an Intraoperative vs. a Standard Wavefront Device
Official Title
To Collect and Compare Data With an Intraoperative Wavefront Device (HeLeNa) to a Standard Wavefront Device: an Explorative Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prim. Prof. Dr. Oliver Findl, MBA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Comparison of intraoperative measured wavefront data with pre- and post-operative wavefront data.
Detailed Description
Different technologies are in use for measuring wavefront aberrations, such as Hartmann-Shack wavefront aberrometry, Tscherning aberrometry, Laser Raytracing and automatic retinoscopy. While Hartmann-Shack wavefront aberrometry, the most widespread of these techniques, uses a lenslet array to record distortions of light bundles coming from a single source form the retina, Tscherning aberrometry uses a matrix of pinholes. Laser Ray Tracing in contrast measures the aberration of a laser beam at different locations. All three systems compare distorsions of the measured light beams with a perfect optical system to calculate the wavefront errors. Repeatability of wavefront devices was studied in young healthy subjects and different devices have been compared to each other. These results do not represent the typical cataract patient. Several factors, such as tear film instability and pupil size, have an influence on the measurements and these factors may change significantly with age. Intraoperative measured data could help to get a better information about wavefront aberrations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract, Wavefront measurement

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intraoperative wavefront measurement
Arm Type
Experimental
Arm Description
Patients will be measured with an intraoperative wavefront device during cataract surgery
Intervention Type
Procedure
Intervention Name(s)
Cataract surgery
Intervention Description
Intraoperative wavefront measurements will be carried out during cataract surgery
Primary Outcome Measure Information:
Title
Wavefront aberration measurements
Description
Measurements of wavefront aberrations using an Hartmann-Shack device will be compared at different time points (pre-, intra-, postoperative).
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cataract Age 21 and older Able to understand the patient information Willing to follow the instructions and attend all follow-up visits Willing to sign informed consent prior to surgery Exclusion Criteria: Relevant other ophthalmic diseases that are likely to reduce the refractive outcome, such as pseudoexfoliation syndrome, traumatic cataract, severe corneal scars Previous ocular surgeries on the study eye Patients who are not able to cooperate, with eccentric fixation or insufficient ability to fixate (tremor, nystagmus) Pregnant or lactating women (pregnancy testing will be performed preoperatively on women of reproductive age)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julius Hienert, MD
Phone
01 910 21-57564
Email
office@viros.at
First Name & Middle Initial & Last Name or Official Title & Degree
Nino Hirnschall, MD
Phone
01 910 21-57564
Email
office@viros.at
Facility Information:
Facility Name
Vienna Institute for Research in Ocular Surgery (VIROS)
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julius Hienert, MD
Phone
01 910 21-57564
Email
office@viros.at
First Name & Middle Initial & Last Name & Degree
Nino Hirnschall, MD
Phone
01 910 21-57564
Email
office@viros.at

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Comparing an Intraoperative vs. a Standard Wavefront Device

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