CataractNCT02203747

Patient Perception of Visual Distortions

An observational study of Cataract and Astigmatism, run by Abbott Medical Optics at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate visual distortions reported by pseudophakic patients. Read more about this study

Who is it for?: Ages 22 years and olderHealthy volunteers can take part
Conditions the study is for: Cataract, Astigmatism
What is being tested?: Administration of patient self-assessment
How many people: 79 participants
Where: 1 siteUnited States
Study dates: Aug 2014to Jan 2015
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Bilaterally-implanted pseudophakic subjects over 22 years of age with astigmatism who meet the inclusion criteria.

Who may be able to join

Corneal astigmatism of at least 0.75 diopters
Bilaterally-implanted with monofocal toric intraocular lenses in both eyes or with monofocal non-toric intraocular lenses in both eyes
At least one month postoperative from second-eye surgery
Ability to understand, read and write English to give consent and complete study questionnaire
Availability, willingness, and sufficient cognitive awareness to comply with examination procedures and study visits
Sign informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
Other protocol-defined inclusion criteria may apply

Who cannot join

Any ocular pathology of clinical significance, as determined by the investigator, other than regular corneal astigmatism, that may affect visual outcomes or influence subjective ocular visual symptoms
Patient is pregnant or is lactating
Participation in any other clinical trial during the last 30 days prior to study enrollment or concurrent participation in any other ongoing clinical trial
Other protocol-defined exclusion criteria may apply

Trial locations and contacts

1 site in 1 country.

United States1 site

Contact AMO for Trial Locations
Santa Ana, California, 92705

Other trials in United States

About this study

The purpose of this study is to evaluate visual distortions reported by pseudophakic patients.

Conditions: Cataract, Astigmatism
Being tested: Administration of patient self-assessment
Medical subject headings: Cataract, Astigmatism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Administration of patient self-assessmentOther

Study groups in NCT02203747
Study group	Role	What they receive
Pseudophakic implanted with toric IOL		Subjects bilaterally implanted with toric IOL Receives: Other: Administration of patient self-assessment
Pseudophakic implanted with non-toric IOL		Subjects bilaterally implanted with non-toric IOL Receives: Other: Administration of patient self-assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

Visual Distortion Symptoms
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.
Measured: Baseline
Visual Distortion Symptoms
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.
Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2014Jan 2015

First posted30 Jul 2014 (estimated)
Study startAug 2014
Primary completionOct 2014
Study completionJan 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CataractStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02203747
Sponsor's protocol ID: TIOL-201-VPAS
Status last verified: Sep 2015
First submitted: 10 Jul 2014
Last updated: 22 Dec 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Patient Perception of Visual Distortions
ClinicalTrials.gov ID: NCT02203747
Acronym / sponsor ID: TIOL-201-VPAS
Conditions: Cataract, Astigmatism
Study type: Observational
Recruitment status: Completed
Enrolment: 79 participants (actual)
Lead sponsor: Abbott Medical OpticsIndustry (pharma, biotech, devices)
Study start: Aug 2014
Primary completion: Oct 2014 (actual)
Study completion: Jan 2015 (actual)
First posted: 30 Jul 2014 (estimated)
Results: Posted 22 Dec 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate visual distortions reported by pseudophakic patients.

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Pseudophakic implanted with toric IOL	–	Other: Administration of patient self-assessmentSubjects bilaterally implanted with toric IOL
Pseudophakic implanted with non-toric IOL	–	Other: Administration of patient self-assessmentSubjects bilaterally implanted with non-toric IOL

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Bilaterally-implanted pseudophakic subjects over 22 years of age with astigmatism who meet the inclusion criteria.

Key inclusion criteria (7 listed)

Corneal astigmatism of at least 0.75 diopters
Bilaterally-implanted with monofocal toric intraocular lenses in both eyes or with monofocal non-toric intraocular lenses in both eyes
At least one month postoperative from second-eye surgery
Ability to understand, read and write English to give consent and complete study questionnaire
Availability, willingness, and sufficient cognitive awareness to comply with examination procedures and study visits

Key exclusion criteria (4 listed)

Any ocular pathology of clinical significance, as determined by the investigator, other than regular corneal astigmatism, that may affect visual outcomes or influence subjective ocular visual symptoms
Patient is pregnant or is lactating
Participation in any other clinical trial during the last 30 days prior to study enrollment or concurrent participation in any other ongoing clinical trial
Other protocol-defined exclusion criteria may apply

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Administration of patient self-assessment	Other	Pseudophakic implanted with non-toric IOL, Pseudophakic implanted with toric IOL

Primary outcome

Visual Distortion Symptoms
Time frame: Baseline
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.
Visual Distortion Symptoms
Time frame: 1 week
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.

Results and safety

Results posted to the registry on 22 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pseudophakic Implanted With Toric IOL	45	45
Pseudophakic Implanted With Non-toric IOL	34	34

Primary outcome: Visual Distortion Symptoms

Time frame: Baseline. Mean (Standard Deviation). Unit: rating of visual distortion symptoms

Measure	Pseudophakic Implanted With Toric IOL n = 44	Pseudophakic Implanted With Non-toric IOL n = 34
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)

Population analysed: 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).

Primary outcome: Visual Distortion Symptoms

Time frame: 1 week. Mean (Standard Deviation). Unit: rating of visual distortion symptoms

Measure	Pseudophakic Implanted With Toric IOL n = 44	Pseudophakic Implanted With Non-toric IOL n = 34
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)

Population analysed: 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).

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pseudophakic Implanted With Toric IOL	0 of 45 (0%)	0 of 45 (0%)	Not reported
Pseudophakic Implanted With Non-toric IOL	0 of 34 (0%)	2 of 34 (5.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Effects of Oxygen Cage Support During Cataract Surgery
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cataract and Astigmatism, run by Abbott Medical Optics at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Distortion Symptoms (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02203747.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2015.