CataractNCT04739397
Evaluation of the EpiGlare Tester for the Measurement of Glare-Induced Changes in BSCVA in Subjects With and Without Cataracts
An observational study of Cataract, run by Epico, LLC at 1 site in United States.
Trial summary
The EpiGlare Tester will identify visual disability resulting from the glare experienced by subjects with cataracts in the glare-induced change in best spectacle corrected visual acuity (BSCVA). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Glare Testing
- Type of treatment
- Medical device
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Candidates were identified from the investigator's usual clinic population. Subjects presenting to the investigators clinic were examined according to the usual procedures. Subjects were classified as having either bilateral cataracts or clear lenses in both eyes
Who may be able to join
- clear lenses OU cataracts OU willing to comply with testing
Who cannot join
- BCVA < 20/63 either eye ocular pathology (ie corneal, macular disease, advanced glaucoma) cognitive dysfunction other conditions that in the investigators opinion made the subject unsuitable candidate
Trial locations and contacts
1 site in 1 country.
About this study
The EpiGlare Tester will identify visual disability resulting from the glare experienced by subjects with cataracts in the glare-induced change in best spectacle corrected visual acuity (BSCVA).
Read the detailed description
Inclusion Criteria:
- Are 18 years of age or older.
- Have been evaluated by an opthalmologist and have a lens determination of either Normal or Cataract in each eye based on slit lamp examination.
- Normal = lens opacity of clear or trace
- Cataract = lens opacity of 2+ or greater
- Have written informed consent as required by the site's IRB and received a copy.
- Are willing and able to comply with testing according to the Investigator.
Exclusion Criteria:
- Best corrected visual acuity is worse than 20/60 in either eye
- Have occular pathology including corneal or macular disease or advanced glaucoma
- Have cognitive dysfunction which limits the ability to cooperate with testing.
- Have presence or history of any other condition or finding or concomitant medication that, in the investigator's opinion, makes the subject unsuitable as a candidate for EpiGlare or study participation or may confound the outcome of the study.
- Conditions
- Cataract
- Being tested
- Glare Testing
- Keywords
- Disability glare, contrast sensitivity, cataract, method evaluation, glare test
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glare TestingDevice
Also called EpiGlare Tester
Vision in Cataract patients were tested with and without the EpiGlare Tester
| Study group | Role | What they receive |
|---|---|---|
| Cataract | Patients with bilateral cataracts with Lens grade 2+ or greater, cataract classification nuclear, cortical or posterior subcapsular Receives: Device: Glare Testing | |
| Non-Cataract | patients with bilateral clear lenses (no cataracts) Receives: Device: Glare Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in best spectacle corrected visual acuity (BSCVA) measurements before and after glare testing using the EpiGlare Tester as the glare source.
Change in best spectacle corrected visual acuity (BSCVA) measurements before and after glare testing using the EpiGlare Tester as the glare source in patients with and without cataracts.
Measured: up to 16 months
Secondary outcomes (1)
Evaluation of functional visual ability using driving and glare subscales from the Refractive Status Vision Profile (RSVP) questionnaire
Correlation of the EpiGlare Tester's glare-induced changes in BSCVA with functional glare disability, as measured by the glare subcategory from the RSVP questionnaire
Measured: up to 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study startNov 2011
- Primary completionNov 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epico, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicole R Fram, MD, Principal investigator, Advanced Vision CareSamuel Masket, MD, Principal investigator, Advanced Vision CareFancis W Price, MD, Principal investigator, Price Vision GroupR. Doyle Stulting, MD, PhD, Principal investigator, Woolfson Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04739397
- Sponsor's protocol ID
- EG-001
- Status last verified
- Jan 2016
- First submitted
- 25 Jan 2016
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Epitropoulos AT, Fram NR, Masket S, Price FW Jr, Snyder ME, Stulting RD. Evaluation of a New Controlled Point Source LED Glare Tester for Disability Glare Detection in Participants With and Without Cataracts. J Refract Surg. 2015 Mar;31(3):196-201. doi: 10.3928/1081597X-20150225-03.
PubMed 25751837
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the EpiGlare Tester for the Measurement of Glare-Induced Changes in BSCVA in Subjects With and Without Cataracts
- ClinicalTrials.gov ID
- NCT04739397
- Acronym / sponsor ID
- EG-001
- Conditions
- Cataract
- Keywords
- Disability glare, contrast sensitivity, cataract, method evaluation, glare test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Epico, LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 4 Feb 2021 (actual)
- 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 EpiGlare Tester will identify visual disability resulting from the glare experienced by subjects with cataracts in the glare-induced change in best spectacle corrected visual acuity (BSCVA).
Detailed description
Inclusion Criteria:
- Are 18 years of age or older.
- Have been evaluated by an opthalmologist and have a lens determination of either Normal or Cataract in each eye based on slit lamp examination.
- Normal = lens opacity of clear or trace
- Cataract = lens opacity of 2+ or greater
- Have written informed consent as required by the site's IRB and received a copy.
- Are willing and able to comply with testing according to the Investigator.
Exclusion Criteria:
- Best corrected visual acuity is worse than 20/60 in either eye
- Have occular pathology including corneal or macular disease or advanced glaucoma
- Have cognitive dysfunction which limits the ability to cooperate with testing.
- Have presence or history of any other condition or finding or concomitant medication that, in the investigator's opinion, makes the subject unsuitable as a candidate for EpiGlare or study participation or may confound the outcome of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cataract | – | Device: Glare TestingPatients with bilateral cataracts with Lens grade 2+ or greater, cataract classification nuclear, cortical or posterior subcapsular |
| Non-Cataract | – | Device: Glare Testingpatients with bilateral clear lenses (no cataracts) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Candidates were identified from the investigator's usual clinic population. Subjects presenting to the investigators clinic were examined according to the usual procedures. Subjects were classified as having either bilateral cataracts or clear lenses in both eyes
Key inclusion criteria (1 listed)
- clear lenses OU cataracts OU willing to comply with testing
Key exclusion criteria (1 listed)
- BCVA < 20/63 either eye ocular pathology (ie corneal, macular disease, advanced glaucoma) cognitive dysfunction other conditions that in the investigators opinion made the subject unsuitable candidate
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 |
|---|---|---|
| Glare TestingAlso: EpiGlare TesterVision in Cataract patients were tested with and without the EpiGlare Tester | Device | Cataract, Non-Cataract |
Primary outcome
Change in best spectacle corrected visual acuity (BSCVA) measurements before and after glare testing using the EpiGlare Tester as the glare source.
Time frame: up to 16 months
Change in best spectacle corrected visual acuity (BSCVA) measurements before and after glare testing using the EpiGlare Tester as the glare source in patients with and without cataracts.
1 secondary outcome
Evaluation of functional visual ability using driving and glare subscales from the Refractive Status Vision Profile (RSVP) questionnaire
Time frame: up to 16 months
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 4 Feb 2021.
- Background: PubMed 25751837Epitropoulos AT, Fram NR, Masket S, Price FW Jr, Snyder ME, Stulting RD. Evaluation of a New Controlled Point Source LED Glare Tester for Disability Glare Detection in Participants With and Without Cataracts. J Refract Surg. 2015 Mar;31(3):196-201. doi: 10.3928/1081597X-20150225-03.
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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.
Nicole R Fram, MD principal investigator
Advanced Vision Care
Samuel Masket, MD principal investigator
Advanced Vision Care
Fancis W Price, MD principal investigator
Price Vision Group
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 Epico, LLC 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 1 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: finished, as of the sponsor's last update on 4 Feb 2021. 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?
Change in best spectacle corrected visual acuity (BSCVA) measurements before and after glare testing using the EpiGlare Tester as the glare source. (time frame: up to 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04739397, which also lists 1 linked publication.
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 4 Feb 2021.