CataractNCT01605058
Visual Performance With a Trifocal Intraocular Lens
An observational study of Cataract, run by BMI Southend Hospital at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the visual performance of a trifocal intraocular lens at distance, near and intermediate viewing, by way of visual acuity measurement, contrast sensitivity. Patient satisfaction and quality of vision will also be assessed by way of a questionnaire. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2012to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients from a private ophthalmology clinic
Who may be able to join
- Age 40-70yrs
- Bilateral implantation of a trifocal intraocular lens
Who cannot join
- existing ocular pathology
- surgical complications
- corneal astigmatism > 1.50DC
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
BMI Southend Hospital
Westclifff-on-Sea, Essex, SS0 9AG
Elizabeth Agrippa, 07795176257, elizabeth.agrippa@gmail.com
About this study
Official title: Visual Performance Adn Quality of Vision Evaluation After Implantation of a Trifocal Intraocular Lens
The purpose of this study is to evaluate the visual performance of a trifocal intraocular lens at distance, near and intermediate viewing, by way of visual acuity measurement, contrast sensitivity.
Patient satisfaction and quality of vision will also be assessed by way of a questionnaire.
Read the detailed description
Monocular and Binocular Unaided (UCVA) and Best Corrected Visual Acuity (BCVA) will be measured at 6m in LogMAR units under photopic conditions (85cd/m2).
Subjective Refraction will be performed to establish any residual refractive error will for distance, intermediate and near.
Defocus Profiles (visual acuity over imposed defocus) are measured for each patient. The patient observes the 6m LogMAR chart through best distance correction, then defocusing is achieved by the addition of pairs of lenses from +2.00D to -4.00D in 0.50D steps.. The LogMAR acuity will be recorded and the data plotted.
Contrast Sensitivity will be evaluated monocularly under photopic (85cd/m2) conditions and mesopic (4cd/m2) using the Pelli-Robson Contrast Sensitivity Chart.
Near and intermediate performance will be evaluated using the Radner Reading Charts to assess acuity (LogRAD units) and reading speed in photopic conditions 85cd/m2
- Conditions
- Cataract
- Medical subject headings
- Cataract
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BMI Southend Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Agrippa, BMI Southend Hospital
- Investigators
- Elizabeth M Agrippa, BSc, Principal investigator, BMI Southend
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01605058
- Sponsor's protocol ID
- TRI 1.1
- Status last verified
- May 2012
- First submitted
- 22 May 2012
- Last updated
- 30 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Performance Adn Quality of Vision Evaluation After Implantation of a Trifocal Intraocular Lens
- ClinicalTrials.gov ID
- NCT01605058
- Acronym / sponsor ID
- TRI 1.1
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- BMI Southend HospitalUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 24 May 2012 (estimated)
- Results
- Not posted in the source record
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 the visual performance of a trifocal intraocular lens at distance, near and intermediate viewing, by way of visual acuity measurement, contrast sensitivity.
Patient satisfaction and quality of vision will also be assessed by way of a questionnaire.
Detailed description
Monocular and Binocular Unaided (UCVA) and Best Corrected Visual Acuity (BCVA) will be measured at 6m in LogMAR units under photopic conditions (85cd/m2).
Subjective Refraction will be performed to establish any residual refractive error will for distance, intermediate and near.
Defocus Profiles (visual acuity over imposed defocus) are measured for each patient. The patient observes the 6m LogMAR chart through best distance correction, then defocusing is achieved by the addition of pairs of lenses from +2.00D to -4.00D in 0.50D steps.. The LogMAR acuity will be recorded and the data plotted.
Contrast Sensitivity will be evaluated monocularly under photopic (85cd/m2) conditions and mesopic (4cd/m2) using the Pelli-Robson Contrast Sensitivity Chart.
Near and intermediate performance will be evaluated using the Radner Reading Charts to assess acuity (LogRAD units) and reading speed in photopic conditions 85cd/m2
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from a private ophthalmology clinic
Key inclusion criteria (2 listed)
- Age 40-70yrs
- Bilateral implantation of a trifocal intraocular lens
Key exclusion criteria (3 listed)
- existing ocular pathology
- surgical complications
- corneal astigmatism > 1.50DC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2012.
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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.
Elizabeth M Agrippa, BSc principal investigator
BMI Southend
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, run by BMI Southend Hospital at 1 site in United Kingdom.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 30 May 2012. 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 30 May 2012.