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Reading Quality in Three Different Patient Groups

Primary Purpose

Pseudophakia

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

About this trial

This is an interventional screening trial for Pseudophakia focused on measuring Pseudophakia, Reading speed

Eligibility Criteria

21 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 21 and older
  • Written informed consent
  • Extended range of vision group: Patients with EROV intraocular lenses and a best-corrected Snellen VA above 0.7 in the weaker eye. Furthermore, the VA of the better eye has to be at least 0.8 (uncorrected visual acuity) and the difference between the eyes should be between 0.5D and 1D)
  • Minimonovision standard IOL group: Patients with monofocal intraocular lenses and a best-corrected Snellen VA above 0.7 in the weaker eye. Furthermore, the VA of the better eye has to be at least 0.8 (uncorrected visual acuity) and the difference between the eyes should be between 0.75D and 1.50D)
  • Single focus distance vision group: Patients with monofocal intraocular lenses and a best-corrected Snellen VA above 0.7 in the weaker eye. Furthermore, the VA of the better eye has to be at least 0.8 (uncorrected visual acuity) and both eyes should have a spherical equivalent between +0.25D and -0.5D
  • Maximum of allowed Cylinder: +0.75D
  • Fluent in German

Exclusion Criteria:

  • Opacities, such as corneal scars
  • In case of pregnancy (pregnancy test will be taken preoperatively in 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

Intraocular lens types

Arm Description

Patients with different types of IOLs (EROV, monofocal, minimonovision) are tested for their reading quality using the EyeTracker device

Outcomes

Primary Outcome Measures

Reading speed
Reading speed in the 3 different IOL groups (EROV, monofocal, minimonovision) will be assessed using the EyeTracker device. Patients are asked to read 4 texts with different contrast levels. The faster the patients can read the texts, the better the outcome.

Secondary Outcome Measures

Full Information

First Posted
November 21, 2018
Last Updated
February 26, 2019
Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
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1. Study Identification

Unique Protocol Identification Number
NCT03751241
Brief Title
Reading Quality in Three Different Patient Groups
Official Title
Evaluation of Reading Quality in Three Different Patient Groups (Extended Range Of Vision vs Minimonovision vs Single Focus Distance Vision)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
January 1, 2022 (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
Influence of different ophthalmic conditions after cataract surgery (extended range of vision IOL (EROV) with micromonovision, minimonovision with standard IOL and single focus distance vision with standard IOL) on reading quality.
Detailed Description
Reading is a complex function. It requires a proper retinal image that is received by the brain. There it is analyzed for letter and word recognition and then the semantics is detected. Reading speed slows down when letters are blurred, or do not have enough contrast or luminance or when binocular fusion is hampered. It also slows down when the understanding is difficult, which is why reading one's mother tongue generally is faster than reading a foreign language. Reading skill is therefore influenced by visuo-motor and cognitive (i.e. linguistic, personality, learning, ageing) factors. Reading ability is currently evaluated using various reading tests, which usually have long paragraphs with small print and shorter ones with larger print, to allow determination of reading acuity. To evaluate sustained reading performance, and reading speed, the International Reading Speed Texts (IReST) which contain longer paragraphs with continuous text of fixed size, have been developed. Although clinical reading tests are thoroughly standardized, a significant inter-individual variation in reading speed exists, as a result of the high influence of cognitive factors. When reading, sensorimotor coordination must happen to make a sequence of fixations and saccades so that new information falls onto the fovea. Eye movement efficiency develops almost in parallel with reading ability, in terms of speed and accuracy, as the child progresses from a beginner to a proficient adult reader. Less skilled readers (e.g. children with reading difficulties) typically make more fixations of longer duration and shorter saccades than skilled readers. For an adult reader mean fixation duration is around 220 to 250 ms. However, fixations of variable durations (from 100 ms to over 500 ms) are recorded during a reading session. Although the distribution of fixation durations varies among individuals, due to differences in reading skill, age and other cognitive factors, it is never normal; it always exhibits a pronounced right tail, i.e. an increased frequency of long fixations. Such distributions can be fitted with an ex-Gaussian function, a convolution of Gaussian (normal) and exponential functions, which could provide more efficient analysis. The team in university of Crete recently showed that pre-retinal factors (e.g. text contrast and luminance) influence the mean of the normal distribution, while cognitive factors affect the number of fixations and the mean of the exponential distribution of fixation duration, due to an increased frequency of long fixations. Moreover, inter-individual variation was significantly improved when analysis was performed separately for visuo-motor vs. cognitive components, with most of variability being attributed to the mean of the exponential distribution. To evaluate functional vision in "simultaneous-image' correction and more specifically visual performance at near, a functional outcome, such as reading speed and ocular fixation times during sustained reading, should be measured. Such recordings could then answer the question how the binocular improvement in reading depends on the difference in acuity between the eyes and the analysis suggested above could help us to distinguish sensory vs. motor components especially in patients with reduced contrast sensitivity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pseudophakia
Keywords
Pseudophakia, Reading speed

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Intraocular lens types
Arm Type
Experimental
Arm Description
Patients with different types of IOLs (EROV, monofocal, minimonovision) are tested for their reading quality using the EyeTracker device
Intervention Type
Device
Intervention Name(s)
EyeTracker
Intervention Description
The EyeTracker is used to determine reading quality of patients with different intraocular lens types (EROV, monofocal, minimonovision)
Primary Outcome Measure Information:
Title
Reading speed
Description
Reading speed in the 3 different IOL groups (EROV, monofocal, minimonovision) will be assessed using the EyeTracker device. Patients are asked to read 4 texts with different contrast levels. The faster the patients can read the texts, the better the outcome.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 21 and older Written informed consent Extended range of vision group: Patients with EROV intraocular lenses and a best-corrected Snellen VA above 0.7 in the weaker eye. Furthermore, the VA of the better eye has to be at least 0.8 (uncorrected visual acuity) and the difference between the eyes should be between 0.5D and 1D) Minimonovision standard IOL group: Patients with monofocal intraocular lenses and a best-corrected Snellen VA above 0.7 in the weaker eye. Furthermore, the VA of the better eye has to be at least 0.8 (uncorrected visual acuity) and the difference between the eyes should be between 0.75D and 1.50D) Single focus distance vision group: Patients with monofocal intraocular lenses and a best-corrected Snellen VA above 0.7 in the weaker eye. Furthermore, the VA of the better eye has to be at least 0.8 (uncorrected visual acuity) and both eyes should have a spherical equivalent between +0.25D and -0.5D Maximum of allowed Cylinder: +0.75D Fluent in German Exclusion Criteria: Opacities, such as corneal scars In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sahand Amir-Asgari, MD
Phone
01 91021-57557
Email
office@viros.at
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Palkovits, MD
Phone
01 91021-57564
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
Sahand Amir-Asgari, MD
Phone
01 91021-57557
Email
office@viros.at
First Name & Middle Initial & Last Name & Degree
Stefan Palkovits, MD
Phone
01 91021-57564
Email
office@viros.at

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Reading Quality in Three Different Patient Groups

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