Lenses, IntraocularNCT01202981
Impact of Glistenings in AcrySof Intraocular Lenses on Visual Quality
An observational study of Lenses, Intraocular and Glistenings, run by University of Utah at 1 site in United States.
Trial summary
This study will assess the impact of IOL glistenings on visual quality and function in patients implanted with a single-piece AcrySof intraocular lens (IOL) that exhibits glistening formations. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Lenses, Intraocular, Glistenings, Visual Quality
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jun 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Enrollment will be stratified into two patient groups based on time since surgery: (1) one to two years post-operative, and (2) two to three years post-op.
Who may be able to join
- Presence of obvious glistenings by slit lamp exam
- Best spectacle corrected visual acuity of 20/20 or better on the Snellen chart at most recent exam
Who cannot join
- Any central corneal pathology that could have impact on vision other than mild guttata felt unlikely to have any impact on corneal clarity.
- Any documented glaucoma of any kind.
- Any macular pathology except minimal drusen without retinal pigment epithelial pathology felt to be consistent with normal vision.
- Any diabetic retinopathy other than minimal background diabetic retinopathy felt unlikely to affect vision.
- Any other cause of central visual acuity loss including optic nerve, occipital cortex dysfunction or amblyopia.
- Diagnosis of dry eye syndrome, defined as any corneal staining with fluorescein
Show all 9Show fewer
- Presence of any central posterior capsular opacification. Previous YAG laser capsulotomy is allowed.
- Any surgical complication having to do with the capsule such as a broken capsule or zonular dialysis or iris trauma or any other complication felt to in any way impact upon the quality of the visual result.
- Any contraindication to pupil dilation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah, John Moran Eye Center
Salt Lake City, Utah, 84132
About this study
Official title: Impact of IOL Glistenings on Visual Quality and Function in Patients Implanted With a Single-Piece AcrySof IOL That Exhibits Glistening Formation
This study will assess the impact of IOL glistenings on visual quality and function in patients implanted with a single-piece AcrySof intraocular lens (IOL) that exhibits glistening formations. The primary objective is to determine if random light scattering (measured by C-Quant)correlates with severity of glistenings, other objective measures of visual function (visual acuity, low contrast visual acuity, low contrast visual acuity with glare), and subjective measures of patients' perceptions of their visual quality after cataract surgery (quality of life survey, reports of symptomology and satisfaction).
- Conditions
- Lenses, Intraocular, Glistenings, Visual Quality
- Keywords
- glistenings, contrast sensitivity, visual quality, straylight, AcrySof IOL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients who had cataract surgery by the Investigators between July 1, 2007 and June 30, 2008. | |
| Group 2 | Patients who had cataract surgery by the Investigators between July 1, 2008 and July 1, 2009. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Light scattering
Correlation of random light scattering (measured with the C-Quant device) with severity of glistenings in the lenses
Measured: Post-opertative
Secondary outcomes (2)
Visual function
Correlation of visual function (visual acuity, contrast acuity and constrast acuity with glare)with glistening severity
Measured: Post-operative
Visual quality
Correlation of visual quality (measured with quality of life questionnaire, and subjective reports of symptoms) with glistening severity
Measured: Post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lenses, IntraocularStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Randall J Olson, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01202981
- Sponsor's protocol ID
- 42093
- Status last verified
- Dec 2014
- First submitted
- 14 Sep 2010
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of IOL Glistenings on Visual Quality and Function in Patients Implanted With a Single-Piece AcrySof IOL That Exhibits Glistening Formation
- ClinicalTrials.gov ID
- NCT01202981
- Acronym / sponsor ID
- 42093
- Conditions
- Lenses, Intraocular, Glistenings, Visual Quality
- Keywords
- glistenings, contrast sensitivity, visual quality, straylight, AcrySof IOL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 16 Sep 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.
This study will assess the impact of IOL glistenings on visual quality and function in patients implanted with a single-piece AcrySof intraocular lens (IOL) that exhibits glistening formations. The primary objective is to determine if random light scattering (measured by C-Quant)correlates with severity of glistenings, other objective measures of visual function (visual acuity, low contrast visual acuity, low contrast visual acuity with glare), and subjective measures of patients' perceptions of their visual quality after cataract surgery (quality of life survey, reports of symptomology and satisfaction).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Patients who had cataract surgery by the Investigators between July 1, 2007 and June 30, 2008. |
| Group 2 | – | –Patients who had cataract surgery by the Investigators between July 1, 2008 and July 1, 2009. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Enrollment will be stratified into two patient groups based on time since surgery: (1) one to two years post-operative, and (2) two to three years post-op.
Key inclusion criteria (2 listed)
- Presence of obvious glistenings by slit lamp exam
- Best spectacle corrected visual acuity of 20/20 or better on the Snellen chart at most recent exam
Key exclusion criteria (9 listed)
- Any central corneal pathology that could have impact on vision other than mild guttata felt unlikely to have any impact on corneal clarity.
- Any documented glaucoma of any kind.
- Any macular pathology except minimal drusen without retinal pigment epithelial pathology felt to be consistent with normal vision.
- Any diabetic retinopathy other than minimal background diabetic retinopathy felt unlikely to affect vision.
- Any other cause of central visual acuity loss including optic nerve, occipital cortex dysfunction or amblyopia.
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
Light scattering
Time frame: Post-opertative
Correlation of random light scattering (measured with the C-Quant device) with severity of glistenings in the lenses
2 secondary outcomes
Visual function
Time frame: Post-operative
Visual quality
Time frame: Post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2014.
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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.
Randall J Olson, MD principal investigator
University of Utah
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 Lenses, Intraocular and Glistenings, run by University of Utah 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 2 inclusion and 9 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 11 Dec 2014. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Light scattering (time frame: Post-opertative). 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 11 Dec 2014.