Cataract ExtractionNCT00842231
Assessment of Visual Performance in Patients With Low Levels of Astigmatism
An observational study of Cataract Extraction and Corneal Astigmatism, run by Alcon Research at 1 site in United States.
Trial summary
To assess visual performance in patients with low levels (0.5-0.75 Diopters) of corneal astigmatism. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract Extraction, Corneal Astigmatism
- What is being tested?
- Visual performance measures
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Mar 2009
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects were selected from a single investigator's primary care clinic.
Who may be able to join
- 50-75 years of age
- Proof of eye exam within the last 12 months
- Operated for uncomplicated, age-related cataracts >3 months
- Corneal astigmatism of 0.5-0.75 diopter
Who cannot join
- Previous ocular or refractive surgery/trauma
- Clinically severe corneal dystrophy
- Amblyopia
- Degenerative visual disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, 76134
About this study
To assess visual performance in patients with low levels (0.5-0.75 Diopters) of corneal astigmatism.
- Conditions
- Cataract Extraction, Corneal Astigmatism
- Being tested
- Visual performance measures
- Keywords
- Corneal astigmatism, post-cataract surgery, visual performance, Corneal astigmatism 0.5-0.75 Diopter
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual performance measuresOther
Collection of visual performance measures in subjects with low levels of astigmatism.
| Study group | Role | What they receive |
|---|---|---|
| Visual performance measures | Collection of visual performance measures in subjects with low levels of astigmatism. Receives: Other: Visual performance measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
High and Low Contrast Acuity
Visual acuity differences between subjects tested with full correction and spherical equivalent (SE) correction at contrast levels of 9% and 25% (low contrast acuity) and 100% (high contrast acuity). LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA. These measurements were performed under photopic conditions by means of 9%, 25%, and 100% contrast ETDRS (Early Treatment Diabetic Retinopathy Study) charts (Vector Vision).
Measured: Day of study visit
Contrast Sensitivity
Contrast Sensitivity (CS) differences between subjects tested with full correction \& spherical equivalent (SE) correction. CS is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. CS is measured in logarithmic units by means of an illuminated box, the CSV 1000 by Vector Vision. Testing was performed under photopic conditions (no glare) \& mesopic conditions (with \& without glare), and was measured at four spatial frequencies of 3, 6, 9, and 12 cycles per degree (cpd). A higher value for the logarithmic units translates to better CS.
Measured: Day of Study Visit
Reading Acuity and Speed
Reading Acuity and Speed differences between subjects tested with full correction and spherical equivalent (SE) correction. Reading Acuity was measured using the Radner reading charts, which are logarithmically scaled at different acuity levels (print sizes), and expressed in terms of logRAD (logrithmic Reading Acuity Determination). Reading speed was measured in words per minute (wpm). The results were presented as Average Reading Speed by Print Size (logRAD).
Measured: Day of Study Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2009
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 Cataract ExtractionStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842231
- Sponsor's protocol ID
- P-08-06
- Status last verified
- Sep 2010
- First submitted
- 11 Feb 2009
- Last updated
- 28 Sep 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Visual Performance in Patients With Low Levels of Astigmatism
- ClinicalTrials.gov ID
- NCT00842231
- Acronym / sponsor ID
- P-08-06
- Conditions
- Cataract Extraction, Corneal Astigmatism
- Keywords
- Corneal astigmatism, post-cataract surgery, visual performance, Corneal astigmatism 0.5-0.75 Diopter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Mar 2009 (actual)
- First posted
- 12 Feb 2009 (estimated)
- Results
- Posted 8 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess visual performance in patients with low levels (0.5-0.75 Diopters) of corneal astigmatism.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Visual performance measures | – | Other: Visual performance measuresCollection of visual performance measures in subjects with low levels of astigmatism. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects were selected from a single investigator's primary care clinic.
Key inclusion criteria (4 listed)
- 50-75 years of age
- Proof of eye exam within the last 12 months
- Operated for uncomplicated, age-related cataracts >3 months
- Corneal astigmatism of 0.5-0.75 diopter
Key exclusion criteria (4 listed)
- Previous ocular or refractive surgery/trauma
- Clinically severe corneal dystrophy
- Amblyopia
- Degenerative visual disorders
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 |
|---|---|---|
| Visual performance measuresCollection of visual performance measures in subjects with low levels of astigmatism. | Other | Visual performance measures |
Primary outcome
High and Low Contrast Acuity
Time frame: Day of study visit
Visual acuity differences between subjects tested with full correction and spherical equivalent (SE) correction at contrast levels of 9% and 25% (low contrast acuity) and 100% (high contrast acuity). LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA. These measurements were performed under photopic conditions by means of 9%, 25%, and 100% contrast ETDRS (Early Treatment Diabetic Retinopathy Study) charts (Vector Vision).
Contrast Sensitivity
Time frame: Day of Study Visit
Contrast Sensitivity (CS) differences between subjects tested with full correction \& spherical equivalent (SE) correction. CS is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. CS is measured in logarithmic units by means of an illuminated box, the CSV 1000 by Vector Vision. Testing was performed under photopic conditions (no glare) \& mesopic conditions (with \& without glare), and was measured at four spatial frequencies of 3, 6, 9, and 12 cycles per degree (cpd). A higher value for the logarithmic units translates to better CS.
Reading Acuity and Speed
Time frame: Day of Study Visit
Reading Acuity and Speed differences between subjects tested with full correction and spherical equivalent (SE) correction. Reading Acuity was measured using the Radner reading charts, which are logarithmically scaled at different acuity levels (print sizes), and expressed in terms of logRAD (logrithmic Reading Acuity Determination). Reading speed was measured in words per minute (wpm). The results were presented as Average Reading Speed by Print Size (logRAD).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Extraction and Corneal Astigmatism, run by Alcon Research 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 4 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 28 Sep 2010. 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 8 Sep 2010). 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?
High and Low Contrast Acuity (time frame: Day of study visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2010.