Trial Outcomes & Findings for Patient Perception of Visual Distortions (NCT NCT02203747)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

79 participants

Primary outcome timeframe

Baseline

Results posted on

2015-12-22

Participant Flow

Participant milestones

Participant milestones
Measure	Pseudophakic Implanted With Toric IOL Subjects implanted with bilateral toric IOL Administration of patient self-assessment	Pseudophakic Implanted With Non-toric IOL Subjects implanted with bilateral non-toric IOL Administration of patient self-assessment
Overall Study STARTED	45	34
Overall Study COMPLETED	45	34
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Patient Perception of Visual Distortions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pseudophakic Implanted With Toric IOL n=45 Participants Subjects implanted with bilateral toric IOL Administration of patient self-assessment	Pseudophakic Implanted With Non-toric IOL n=34 Participants Subjects implanted with bilateral non-toric IOL Administration of patient self-assessment	Total n=79 Participants Total of all reporting groups
Age, Categorical <=18 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 participants n=5 Participants	9 participants n=7 Participants	17 participants n=5 Participants
Age, Categorical >=65 years	36 participants n=5 Participants	25 participants n=7 Participants	61 participants n=5 Participants
Age, Continuous	71.39 years STANDARD_DEVIATION 8.34 • n=5 Participants	69.68 years STANDARD_DEVIATION 11.08 • n=7 Participants	70.64 years STANDARD_DEVIATION 9.59 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	18 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	16 Participants n=7 Participants	38 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants	34 participants n=7 Participants	79 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Pseudophakic Implanted With Toric IOL n=44 Participants Subjects implanted with toric IOL Administration of patient self-assessment	Pseudophakic Implanted With Non-toric IOL n=34 Participants Subjects implanted with non-toric IOL Administration of patient self-assessment
Visual Distortion Symptoms Lines that tilt/slant	0.89 rating of visual distortion symptoms Standard Deviation 1.13	0.38 rating of visual distortion symptoms Standard Deviation 0.65
Visual Distortion Symptoms Flat surfaces appear curved	0.64 rating of visual distortion symptoms Standard Deviation 0.97	0.38 rating of visual distortion symptoms Standard Deviation 0.55
Visual Distortion Symptoms objects appear further away/closer than they are	0.66 rating of visual distortion symptoms Standard Deviation 0.78	0.56 rating of visual distortion symptoms Standard Deviation 0.70
Visual Distortion Symptoms Objects have different size/shape	0.75 rating of visual distortion symptoms Standard Deviation 0.99	0.62 rating of visual distortion symptoms Standard Deviation 0.92
Visual Distortion Symptoms physical discomfort related to vision	0.73 rating of visual distortion symptoms Standard Deviation 0.90	0.56 rating of visual distortion symptoms Standard Deviation 0.75

PRIMARY outcome

Timeframe: 1 week

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Pseudophakic Implanted With Toric IOL n=44 Participants Subjects implanted with toric IOL Administration of patient self-assessment	Pseudophakic Implanted With Non-toric IOL n=34 Participants Subjects implanted with non-toric IOL Administration of patient self-assessment
Visual Distortion Symptoms Lines that tilt/slant	0.82 rating of visual distortion symptoms Standard Deviation 0.95	0.65 rating of visual distortion symptoms Standard Deviation 0.85
Visual Distortion Symptoms Flat surfaces appear curved	0.64 rating of visual distortion symptoms Standard Deviation 0.87	0.38 rating of visual distortion symptoms Standard Deviation 0.6
Visual Distortion Symptoms objects appear further away/closer than they are	0.64 rating of visual distortion symptoms Standard Deviation 0.78	0.47 rating of visual distortion symptoms Standard Deviation 0.61
Visual Distortion Symptoms Objects have different size/shape	0.61 rating of visual distortion symptoms Standard Deviation 0.84	0.47 rating of visual distortion symptoms Standard Deviation 0.79
Visual Distortion Symptoms physical discomfort related to vision	0.59 rating of visual distortion symptoms Standard Deviation 0.92	0.47 rating of visual distortion symptoms Standard Deviation 0.79

Adverse Events

Pseudophakic Implanted With Toric IOL

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pseudophakic Implanted With Non-toric IOL

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pseudophakic Implanted With Toric IOL n=45 participants at risk Subjects implanted with toric IOL Administration of patient self-assessment	Pseudophakic Implanted With Non-toric IOL n=34 participants at risk Subjects implanted with non-toric IOL Administration of patient self-assessment
Surgical and medical procedures Headache with dizziness and nausea	0.00% 0/45	2.9% 1/34 • Number of events 1
Immune system disorders Achiness and pressure	0.00% 0/45	2.9% 1/34 • Number of events 1

Additional Information

Carrie Garufis

Abbott Medical Optics

Phone: 714-566-3728

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Clinical Trial Agreement
Publication restrictions are in place

Restriction type: OTHER