Patients Implanted With Monofocal Intraocular LensNCT01191515
Prospective Evaluation of Near and Intermediate Visual Outcomes With Monofocal Intraocular Lenses: The Mast Study
An observational study of Patients Implanted With Monofocal Intraocular Lens, run by Innovative Medical at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the near and intermediate visual outcomes of patients who have undergone routine cataract surgery (removal of cloudy crystalline lens) with phacoemulsification (the break-up and removal of cloudy lens) and monofocal IOL ( a plastic lens implanted to replace eye's natural lens)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patients Implanted With Monofocal Intraocular Lens
- What is being tested?
- Monofocal Intraocular Lenses
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Oct 2012
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Prospective evaluation of 200 patients male or female at least 18 years of age who have previously undergone phacoemulsification (the break-up and removal of a cataract) between one and 36 months earlier
Who may be able to join
- Male or female patients at least 18 years of age
- Patients who underwent routine cataract surgery with phacoemulsification and monofocal iol placement in the capsular bag in at least one eye within the last 36 months
- At least 1 month postop before follow-up evaluation
- All Patients must have a DCVA of 20/25 or better
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Advanced Vision Institute
Williamsburg, Virginia, 23188
Glenn Campbell, MD
About this study
The purpose of this study is to evaluate the near and intermediate visual outcomes of patients who have undergone routine cataract surgery (removal of cloudy crystalline lens) with phacoemulsification (the break-up and removal of cloudy lens) and monofocal IOL ( a plastic lens implanted to replace eye's natural lens) placement in the capsular bag in at least one eye.
- Being tested
- Monofocal Intraocular Lenses
- Keywords
- Previous Cataract patients, Monofocal IOL implant, Evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monofocal Intraocular LensesDevice
Monofocal Intraocular Lenses
| Study group | Role | What they receive |
|---|---|---|
| Near visual outcomes with Monofocal IOL | Evaluation of intermediate visual outcomes of patients undergoing routine cataract surgery with phacoemulsification and monofocal IOl placement in the capsular bag in at least one eye. Receives: Device: Monofocal Intraocular Lenses | |
| Intermediate Visual outcomes | Evaluation of intermediate visual outcomes of patients undergoing routine cataract surgery with phacoemulsification and monofocal IOl placement in the capsular bag in at least one eye. Receives: Device: Monofocal Intraocular Lenses |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionOct 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Implanted With Monofocal Intraocular LensStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovative Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Staar Surgical Company
- Investigators
- Glenn Campbell, MD, Principal investigator, Advanced Vision Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191515
- Sponsor's protocol ID
- The Mast Study
- Status last verified
- Jun 2012
- First submitted
- 27 Aug 2010
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Near and Intermediate Visual Outcomes With Monofocal Intraocular Lenses: The Mast Study
- ClinicalTrials.gov ID
- NCT01191515
- Acronym / sponsor ID
- The Mast Study
- Keywords
- Previous Cataract patients, Monofocal IOL implant, Evaluation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Innovative MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Staar Surgical Company
- Study start
- Aug 2010
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 30 Aug 2010 (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 near and intermediate visual outcomes of patients who have undergone routine cataract surgery (removal of cloudy crystalline lens) with phacoemulsification (the break-up and removal of cloudy lens) and monofocal IOL ( a plastic lens implanted to replace eye's natural lens) placement in the capsular bag in at least one eye.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Near visual outcomes with Monofocal IOL | – | Device: Monofocal Intraocular LensesEvaluation of intermediate visual outcomes of patients undergoing routine cataract surgery with phacoemulsification and monofocal IOl placement in the capsular bag in at least one eye. |
| Intermediate Visual outcomes | – | Device: Monofocal Intraocular LensesEvaluation of intermediate visual outcomes of patients undergoing routine cataract surgery with phacoemulsification and monofocal IOl placement in the capsular bag in at least one eye. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective evaluation of 200 patients male or female at least 18 years of age who have previously undergone phacoemulsification (the break-up and removal of a cataract) between one and 36 months earlier
Key inclusion criteria (4 listed)
- Male or female patients at least 18 years of age
- Patients who underwent routine cataract surgery with phacoemulsification and monofocal iol placement in the capsular bag in at least one eye within the last 36 months
- At least 1 month postop before follow-up evaluation
- All Patients must have a DCVA of 20/25 or better
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Monofocal Intraocular LensesMonofocal Intraocular Lenses | Device | Intermediate Visual outcomes, Near visual outcomes with Monofocal IOL |
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 14 Jun 2012.
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.
Glenn Campbell, MD principal investigator
Advanced Vision Institute
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 Patients Implanted With Monofocal Intraocular Lens, run by Innovative Medical 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 0 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 14 Jun 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Piel ((951)653-5566, j.piel@imedsonline.com), or a site near the patient. 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 14 Jun 2012.