GlisteningsPhase 4AVS Vs MA50BMNCT01131481
Evaluation of Glistenings in Intraocular Lenses Implanted in Normal Patients Following Routine Cataract Extraction.
A Phase 4 study testing Intraocular lens in people with Glistenings, run by Fry Eye Associates and Fry Eye Surgery Center at 1 site in United States.
Trial summary
Evaluation of glistenings in intraocular lenses implanted in normal patients following routine cataract surgery. The lenses used will be Model X-60 made by the AVS company Vs AcrySof MA50BM made by the Alcon company. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glistenings
- What is being tested?
- Intraocular lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Jul 2013
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Bilateral cataracts requiring surgery
- Potential visual acuity of 20/40 or better in both eyes
- Require IOL power in range of 15-25 diopters
- Pupillary dilation of at least 6mm
- Willing and able to provide informed consent and attend follow-up appointments to 3 years
Who cannot join
- Any co-existing ocular disease or previous ocular surgery that would confound findings in the study, especially those effecting quality of vision. Examples include Macular degeneration amblyopia and prior epiretinal membrane peel.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Glistenings in Intraocular Lenses AVS Model X-60 Vs AcrySof MA50-BM.
Evaluation of glistenings in intraocular lenses implanted in normal patients following routine cataract surgery. The lenses used will be Model X-60 made by the AVS company Vs AcrySof MA50BM made by the Alcon company.
- Conditions
- Glistenings
- Being tested
- Intraocular lens
- Keywords
- cataracts,glistenings,intraocular lenses.
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular lensDevice
| Study group | Role | What they receive |
|---|---|---|
| AcrySof MA50BM,AVS Model X-60 | Other | AcrySof MA50BM, AVS Model X-60 Receives: Device: Intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Glistenings between the Model X-60 made by the AVS company and AcrySof MA50BM made by the Alcon company.
Each patient will have the same testing at each visit. Photos will be taken of the glistenings,sent off and counted.
Measured: The patient will be followed 1-2 days after surgery on the first eye and 1-2 days after surgery on the second eye,1-2 months after surgery on both eyes,4-6 months after surgery on both eyes and 1,2 and 3 yrs after surgery on both eyes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2013 (estimated)
- Study completionJul 2013 (estimated)
Why it stopped: lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlisteningsStudies 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
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fry Eye Associates and Fry Eye Surgery Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Investigators
- Luther Fry, MD, Principal investigator, Fry Eye Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131481
- Sponsor's protocol ID
- Protocol Number 7248
- Acronym
- AVS Vs MA50BM
- Status last verified
- Jun 2011
- First submitted
- 26 May 2010
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Glistenings in Intraocular Lenses AVS Model X-60 Vs AcrySof MA50-BM.
- ClinicalTrials.gov ID
- NCT01131481
- Acronym / sponsor ID
- AVS Vs MA50BM / Protocol Number 7248
- Conditions
- Glistenings
- Keywords
- cataracts,glistenings,intraocular lenses.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fry Eye Associates and Fry Eye Surgery CenterUniversity, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Study start
- Jun 2010
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 27 May 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.
Evaluation of glistenings in intraocular lenses implanted in normal patients following routine cataract surgery. The lenses used will be Model X-60 made by the AVS company Vs AcrySof MA50BM made by the Alcon company.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AcrySof MA50BM,AVS Model X-60 | Other | Device: Intraocular lensAcrySof MA50BM, AVS Model X-60 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years or older
- Bilateral cataracts requiring surgery
- Potential visual acuity of 20/40 or better in both eyes
- Require IOL power in range of 15-25 diopters
- Pupillary dilation of at least 6mm
Key exclusion criteria (1 listed)
- Any co-existing ocular disease or previous ocular surgery that would confound findings in the study, especially those effecting quality of vision. Examples include Macular degeneration amblyopia and prior epiretinal membrane peel.
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 |
|---|---|---|
| Intraocular lens | Device | AcrySof MA50BM,AVS Model X-60 |
Primary outcome
Evaluation of Glistenings between the Model X-60 made by the AVS company and AcrySof MA50BM made by the Alcon company.
Time frame: The patient will be followed 1-2 days after surgery on the first eye and 1-2 days after surgery on the second eye,1-2 months after surgery on both eyes,4-6 months after surgery on both eyes and 1,2 and 3 yrs after surgery on both eyes.
Each patient will have the same testing at each visit. Photos will be taken of the glistenings,sent off and counted.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2015.
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.
Luther Fry, MD principal investigator
Fry Eye Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intraocular lens in people with Glistenings, run by Fry Eye Associates and Fry Eye Surgery Center 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 6 inclusion and 1 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: withdrawn, as of the sponsor's last update on 15 Sep 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Evaluation of Glistenings between the Model X-60 made by the AVS company and AcrySof MA50BM made by the Alcon company. (time frame: The patient will be followed 1-2 days after surgery on the first eye and 1-2 days after surgery on the second eye,1-2 months after surgery on both eyes,4-6 months after surgery on both eyes and 1,2 and 3 yrs after surgery on both eyes.). 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 15 Sep 2015.