CataractsNCT00934960
Multifocals and Accommodating/Bilateral Implantation of Different Multifocal Intraocular Lens (IOLs)
An observational study of Cataracts, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to evaluate vision at different distances (far (13 ft), intermediate (2.0 ft) and near (13 to 15 in)) with and without the patient's glasses (if the patient wears them), range of vision (the difference between the farthest distance and the closest distance that the patient can comfortably… Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataracts
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Oct 2009
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 50 patients of both sexes and any race or ethnic background who underwent uneventful routine bilateral cataract extraction and multifocal or accomodating intraocular lens implantation will be included. Subjects will be divided in 5 groups of 10 subjects each based on the IOL implanted as follows: ReSTOR +4.0 D, ReSTOR +3.0 D, Crystalens, ReZoom, and Mix-and-match (patients implanted with ReSTOR in one eye and ReZoom in the fellow eye).
Who may be able to join
- Subjects MUST fulfill the following conditions to qualify for enrollment into the trial
- Subject must have a multifocal or an accommodating IOL implanted bilaterally.
- Age: 40 to 90 years old.
- At least 3 months after cataract extraction and intraocular lens implantation in the second eye.
- Willing and able to comply with scheduled visit and other study procedures.
Who cannot join
- Subjects with ANY of the following conditions on the eligibility exam may NOT be enrolled into the trial.
- Ocular pathology affecting visual acuity: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmus or macrophthalmus, optic nerve atrophy, macular degeneration (with best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.
- Keratometric astigmatism exceeding 2.00 diopters.
- Planned postoperative refraction for mono-vision.
- Uncontrolled diabetes.
- Use of any systemic or topical drug known to interfere with visual performance.
Show all 12Show fewer
- Contact lens use during the active treatment portion of the trial.
- Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis.
- Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control.
- Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.
- Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in either eye.
- Other ocular surgery at the time of the cataract extraction.
Trial locations and contacts
1 site in 1 country.
United States1 site
Helga Sandoval, MD
Charleston, South Carolina, 29425
About this study
Official title: Distance, Intermediate and Near Visual Outcomes, Range of Vision and Patient Satisfaction After Bilateral Implantation of Different Multifocal IOLs
The purpose of this study is to evaluate vision at different distances (far (13 ft), intermediate (2.0 ft) and near (13 to 15 in)) with and without the patient's glasses (if the patient wears them), range of vision (the difference between the farthest distance and the closest distance that the patient can comfortably read 20/25 of the near card), and patient satisfaction (how satisfied/happy is the patient with their vision) following bilateral implantation of different multifocal IOLs after routine phacoemulsification.
The patients are being asked to participate in this study because you have had cataract surgery and have received one of the IOLs implanted: ReSTOR +4.0 D, ReSTOR +3.0 D, Crystalens, and/or ReZoom. The investigator in charge of this study is Dr. Helga Sandoval. This study is being conducted at Storm Eye Institute at the Medical University of South Carolina and will involve approximately 50 volunteers.
Read the detailed description
STUDY DESIGN:
This is a prospective, non-randomized, unmasked pilot study.
- SETTING: Storm Eye Institute, Medical University of South Carolina, Charleston, SC
- SUBJECTS
A total of 50 patients of both sexes and any race or ethnic background who underwent uneventful routine bilateral cataract extraction and multifocal or accommodating intraocular lens implantation will be included. Subjects will be divided in 5 groups of 10 subjects each based on the IOL implanted as follows: ReSTOR +4.0 D, ReSTOR +3.0 D, Crystalens, ReZoom, and Mix-and-match (patients implanted with ReSTOR in one eye and ReZoom in the fellow eye).
Assessment included a thorough medical history and a complete eye examination. The latter will include ETDRS visual acuity at distance (4 mts), intermediate (60 cm) and near (33 or 40 cm accordingly to the lens, under photopic conditions) evaluated uncorrected and best-corrected as well as distance-corrected near and intermediate visual acuity, , and range of vision (uncorrected and distance-corrected); the previous tests will be done per eye and both eyes (visual summation). Slit-lamp exam, eye dominance, stereopsis, pupil size under photopic conditions, corneal topography and a satisfaction questionnaire will be evaluated as well. A defocus curve will be performed as follows: a phoropter and a 100% contrast ETDRS chart positioned 4 meters from the subject under photopic lighting conditions will be used. Manifest refraction will be used to designate the zero (0) baseline. To begin the testing, subjects will be defocused -5.00 D spherical correction from their best distance correction (manifest refraction). The logMAR acuity at this refraction will be recorded. Minus spherical power will be decreased in 0.50 D increments (i.e., -4.50 D, -4.00 D, -3.50 D, etc.) with logMAR acuity recorded at each change in correction until only the best distance correction (manifest refraction) remains. In a further step, subjects will be defocused +2.00 D spherical correction from the best distance correction (manifest refraction) and the logMAR acuity will be recorded. Plus spherical power will be decreased in 0.50 D increments (i.e., +1.50 D, +1.00 D, +0.50 D) with logMAR acuity recorded at each change in correction until only the best distance correction (manifest refraction) remains.
- Conditions
- Cataracts
- Keywords
- vision, Intraocular lenses
- Medical subject headings
- Cataract
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate visual outcomes at distance, intermediate and near as well as range of vision and patient satisfaction after bilateral implantation of multifocal or accommodating IOLs post routine cataract extraction at least 3 months after surgery.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startMar 2009
- Primary completionOct 2009
- Study completionOct 2009
Why it stopped: PI separated employment from the university.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractsStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Investigators
- Helga P Sandoval, MD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934960
- Sponsor's protocol ID
- MRC 09-001
- Status last verified
- Nov 2009
- First submitted
- 6 Jul 2009
- Last updated
- 18 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distance, Intermediate and Near Visual Outcomes, Range of Vision and Patient Satisfaction After Bilateral Implantation of Different Multifocal IOLs
- ClinicalTrials.gov ID
- NCT00934960
- Acronym / sponsor ID
- MRC 09-001
- Conditions
- Cataracts
- Keywords
- vision, Intraocular lenses
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI separated employment from the university.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 8 Jul 2009 (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 vision at different distances (far (13 ft), intermediate (2.0 ft) and near (13 to 15 in)) with and without the patient's glasses (if the patient wears them), range of vision (the difference between the farthest distance and the closest distance that the patient can comfortably read 20/25 of the near card), and patient satisfaction (how satisfied/happy is the patient with their vision) following bilateral implantation of different multifocal IOLs after routine phacoemulsification.
The patients are being asked to participate in this study because you have had cataract surgery and have received one of the IOLs implanted: ReSTOR +4.0 D, ReSTOR +3.0 D, Crystalens, and/or ReZoom. The investigator in charge of this study is Dr. Helga Sandoval. This study is being conducted at Storm Eye Institute at the Medical University of South Carolina and will involve approximately 50 volunteers.
Detailed description
STUDY DESIGN:
This is a prospective, non-randomized, unmasked pilot study.
- SETTING: Storm Eye Institute, Medical University of South Carolina, Charleston, SC
- SUBJECTS
A total of 50 patients of both sexes and any race or ethnic background who underwent uneventful routine bilateral cataract extraction and multifocal or accommodating intraocular lens implantation will be included. Subjects will be divided in 5 groups of 10 subjects each based on the IOL implanted as follows: ReSTOR +4.0 D, ReSTOR +3.0 D, Crystalens, ReZoom, and Mix-and-match (patients implanted with ReSTOR in one eye and ReZoom in the fellow eye).
Assessment included a thorough medical history and a complete eye examination. The latter will include ETDRS visual acuity at distance (4 mts), intermediate (60 cm) and near (33 or 40 cm accordingly to the lens, under photopic conditions) evaluated uncorrected and best-corrected as well as distance-corrected near and intermediate visual acuity, , and range of vision (uncorrected and distance-corrected); the previous tests will be done per eye and both eyes (visual summation). Slit-lamp exam, eye dominance, stereopsis, pupil size under photopic conditions, corneal topography and a satisfaction questionnaire will be evaluated as well. A defocus curve will be performed as follows: a phoropter and a 100% contrast ETDRS chart positioned 4 meters from the subject under photopic lighting conditions will be used. Manifest refraction will be used to designate the zero (0) baseline. To begin the testing, subjects will be defocused -5.00 D spherical correction from their best distance correction (manifest refraction). The logMAR acuity at this refraction will be recorded. Minus spherical power will be decreased in 0.50 D increments (i.e., -4.50 D, -4.00 D, -3.50 D, etc.) with logMAR acuity recorded at each change in correction until only the best distance correction (manifest refraction) remains. In a further step, subjects will be defocused +2.00 D spherical correction from the best distance correction (manifest refraction) and the logMAR acuity will be recorded. Plus spherical power will be decreased in 0.50 D increments (i.e., +1.50 D, +1.00 D, +0.50 D) with logMAR acuity recorded at each change in correction until only the best distance correction (manifest refraction) remains.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 50 patients of both sexes and any race or ethnic background who underwent uneventful routine bilateral cataract extraction and multifocal or accomodating intraocular lens implantation will be included. Subjects will be divided in 5 groups of 10 subjects each based on the IOL implanted as follows: ReSTOR +4.0 D, ReSTOR +3.0 D, Crystalens, ReZoom, and Mix-and-match (patients implanted with ReSTOR in one eye and ReZoom in the fellow eye).
Key inclusion criteria (5 listed)
- Subjects MUST fulfill the following conditions to qualify for enrollment into the trial
- Subject must have a multifocal or an accommodating IOL implanted bilaterally.
- Age: 40 to 90 years old.
- At least 3 months after cataract extraction and intraocular lens implantation in the second eye.
- Willing and able to comply with scheduled visit and other study procedures.
Key exclusion criteria (12 listed)
- Subjects with ANY of the following conditions on the eligibility exam may NOT be enrolled into the trial.
- Ocular pathology affecting visual acuity: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmus or macrophthalmus, optic nerve atrophy, macular degeneration (with best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.
- Keratometric astigmatism exceeding 2.00 diopters.
- Planned postoperative refraction for mono-vision.
- Uncontrolled diabetes.
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
To evaluate visual outcomes at distance, intermediate and near as well as range of vision and patient satisfaction after bilateral implantation of multifocal or accommodating IOLs post routine cataract extraction at least 3 months after surgery.
Time frame: six months
Results and safety
The study was stopped early (reason given: PI separated employment from the university.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2009.
Related trials for Cataracts
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
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.
Helga P Sandoval, MD principal investigator
Associate Professor
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 Cataracts, run by Medical University of South Carolina 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 5 inclusion and 12 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: stopped early, as of the sponsor's last update on 18 Nov 2009. 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?
The study was stopped early (reason given: PI separated employment from the university.). Results are not available in the source record.
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?
To evaluate visual outcomes at distance, intermediate and near as well as range of vision and patient satisfaction after bilateral implantation of multifocal or accommodating IOLs post routine cataract extraction at least 3 months after surgery. (time frame: six months). 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 18 Nov 2009.