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Patient Perception of Visual Distortions

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ClinicalTrials.gov Identifier: NCT02203747
Recruitment Status : Completed
First Posted : July 30, 2014
Results First Posted : December 22, 2015
Last Update Posted : December 22, 2015
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics

Study Type Observational
Study Design Observational Model: Case Control;   Time Perspective: Prospective
Conditions Cataract
Astigmatism
Intervention Other: Administration of patient self-assessment
Enrollment 79
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pseudophakic Implanted With Toric IOL Pseudophakic Implanted With Non-toric IOL
Hide Arm/Group Description

Subjects implanted with bilateral toric IOL

Administration of patient self-assessment

Subjects implanted with bilateral non-toric IOL

Administration of patient self-assessment

Period Title: Overall Study
Started 45 34
Completed 45 34
Not Completed 0 0
Arm/Group Title Pseudophakic Implanted With Toric IOL Pseudophakic Implanted With Non-toric IOL Total
Hide Arm/Group Description

Subjects implanted with bilateral toric IOL

Administration of patient self-assessment

Subjects implanted with bilateral non-toric IOL

Administration of patient self-assessment

Total of all reporting groups
Overall Number of Baseline Participants 45 34 79
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants 34 participants 79 participants
<=18 years 0 0 0
Between 18 and 65 years 8 9 17
>=65 years 36 25 61
[1]
Measure Description: Total participants in the "Pseudophakic implanted with toric IOL" group is 45, but age was not reported for one subject.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 34 participants 79 participants
71.39  (8.34) 69.68  (11.08) 70.64  (9.59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 34 participants 79 participants
Female
23
  51.1%
18
  52.9%
41
  51.9%
Male
22
  48.9%
16
  47.1%
38
  48.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 45 participants 34 participants 79 participants
45 34 79
1.Primary Outcome
Title Visual Distortion Symptoms
Hide Description Subjective rating of visual distortion symptoms under overall conditions at baseline. Rating scale consisted of the following categories: "did not experience" (rating = 0), "mild" (rating = 1), "moderate" (rating = 2), or "severe" (rating = 3), therefore, the lower values represent the best outcome. The minimum score was 0 and the maximum score was 3.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 45 subjects in the "Pseudophakic implanted with toric IOL" group, one (#102) was excluded due to a protocol deviation (improper method used to simulate visual distortion).
Arm/Group Title Pseudophakic Implanted With Toric IOL Pseudophakic Implanted With Non-toric IOL
Hide Arm/Group Description:

Subjects implanted with toric IOL

Administration of patient self-assessment

Subjects implanted with non-toric IOL

Administration of patient self-assessment

Overall Number of Participants Analyzed 44 34
Mean (Standard Deviation)
Unit of Measure: rating of visual distortion symptoms
Lines that tilt/slant 0.89  (1.13) 0.38  (0.65)
Flat surfaces appear curved 0.64  (0.97) 0.38  (0.55)
objects appear further away/closer than they are 0.66  (0.78) 0.56  (0.70)
Objects have different size/shape 0.75  (0.99) 0.62  (0.92)
physical discomfort related to vision 0.73  (0.90) 0.56  (0.75)
2.Primary Outcome
Title Visual Distortion Symptoms
Hide Description Subjective rating of visual distortion symptoms under overall conditions at baseline. Rating scale consisted of the following categories: "did not experience" (rating = 0), "mild" (rating = 1), "moderate" (rating = 2), or "severe" (rating = 3), therefore, the lower values represent the best outcome. The minimum score was 0 and the maximum score was 3.
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 45 subjects in the "Pseudophakic implanted with toric IOL" group, one (#307) was excluded due to a protocol deviation (subject visit was completed outside of the protocol-defined visit interval).
Arm/Group Title Pseudophakic Implanted With Toric IOL Pseudophakic Implanted With Non-toric IOL
Hide Arm/Group Description:

Subjects implanted with toric IOL

Administration of patient self-assessment

Subjects implanted with non-toric IOL

Administration of patient self-assessment

Overall Number of Participants Analyzed 44 34
Mean (Standard Deviation)
Unit of Measure: rating of visual distortion symptoms
Lines that tilt/slant 0.82  (0.95) 0.65  (0.85)
Flat surfaces appear curved 0.64  (0.87) 0.38  (0.6)
objects appear further away/closer than they are 0.64  (0.78) 0.47  (0.61)
Objects have different size/shape 0.61  (0.84) 0.47  (0.79)
physical discomfort related to vision 0.59  (0.92) 0.47  (0.79)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pseudophakic Implanted With Toric IOL Pseudophakic Implanted With Non-toric IOL
Hide Arm/Group Description

Subjects implanted with toric IOL

Administration of patient self-assessment

Subjects implanted with non-toric IOL

Administration of patient self-assessment

All-Cause Mortality
Pseudophakic Implanted With Toric IOL Pseudophakic Implanted With Non-toric IOL
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pseudophakic Implanted With Toric IOL Pseudophakic Implanted With Non-toric IOL
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/45 (0.00%)      0/34 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pseudophakic Implanted With Toric IOL Pseudophakic Implanted With Non-toric IOL
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/45 (0.00%)      2/34 (5.88%)    
Immune system disorders     
Achiness and pressure  [1]  0/45 (0.00%)  0 1/34 (2.94%)  1
Surgical and medical procedures     
Headache with dizziness and nausea  [2]  0/45 (0.00%)  0 1/34 (2.94%)  1
Indicates events were collected by systematic assessment
[1]
Subject experienced achiness and eye pressure after experiencing a lupus flare-up, unrelated to study procedure.
[2]
Subject reported feeling nausea with a headache and dizziness hours after astigmatism induction
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Clinical Trial Agreement
Results Point of Contact
Name/Title: Carrie Garufis
Organization: Abbott Medical Optics
Phone: 714-566-3728
Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT02203747     History of Changes
Other Study ID Numbers: TIOL-201-VPAS
First Submitted: July 10, 2014
First Posted: July 30, 2014
Results First Submitted: September 30, 2015
Results First Posted: December 22, 2015
Last Update Posted: December 22, 2015