Vision DisabilityNCT02244892
Correlation of Scheimpflug Densitometry Measurements of Corneal Haze With Disability Glare
An observational study of Vision Disability, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
Disability glare is described as "halos" or "starbursts" around bright sources of light that can cause discomfort and reduce vision. The cornea is the clear "window" at the front of the eye, but certain conditions such as a previous infection can leave a scar. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vision Disability
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Sep 2014
- 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
- No healthy volunteers
- Adult, Older adult
Study population: This will be a prospective study in which all eligible and willing patients will undergo the same workup. The expected duration is 1 year, and the trial will be stopped once the needed number of subjects has been enrolled. Testing will be performed on the day of the routine clinical visit and will only extend the appointment by less than 30 minutes. All patients receiving ophthalmological care at University Hospitals (both at the main Case Medical Center site and the satellite offices at Westlake and Landerbrook) who meet the inclusion and exclusion criteria would be eligible for this study. Subjects will be identified who have an isolated corneal scar in one eye and otherwise healthy eyes with no clinical evidence of lens or retinal pathology. Patients will be enrolled between September 6, 2014 and September 5, 2015, with the goal of recruiting at least 80-100 subjects.
Who may be able to join
- Age 18 years or greater
- Presence of corneal scar in one eye
- No clinical evidence of any other intraocular pathology
Who cannot join
- Clinical evidence of other ocular pathology (e.g. cataracts)
- Pediatric patients less than 18 years old
- Bilateral corneal pathology
- Presence of active corneal inflammation/infection
- Presence of degenerative corneal disease
- History of prior corneal surgery (e.g. corneal graft)
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
About this study
Disability glare is described as "halos" or "starbursts" around bright sources of light that can cause discomfort and reduce vision. The cornea is the clear "window" at the front of the eye, but certain conditions such as a previous infection can leave a scar. Corneal scars can cause disability glare by scattering and spreading incoming light instead of allowing it to focus on the back of the eye (retina) to get a crisp image. In this study, the corneal scar will be analyzed using a new device that measures scar density (Pentacam), and a relationship with disability glare will be made. This can help us further understand disability glare and make better decisions in the future on when to treat these scars to help patients see better.
Read the detailed description
Disability glare is a phenomenon commonly described as starbursts and halos that results in difficulty seeing clearly in the presence of bright "blinding" light. It can appear as if a veil of light is cast over the world outside. Optically, this occurs when incoming light is scattered in the eye instead of being focused on the retina. This is called straylight, and it diffusely illuminates the retina which causes desensitization of the photoreceptors and reduces the contrast of the retinal image (Lombardo \& Lombardo, 2010). The main sources of scatter in the human eye are opacities in the clear ocular media, primarily due to diffusion and loss of transparency in the cornea and lens, as well as within the retina. While the lens is the largest contributor to light scatter (especially with cataract formation and aging), opacification of the cornea (e.g. scars or haze) can similarly cause intraocular light scattering, resulting in disability glare and decreased contrast sensitivity (Fan-Paul et al., 2002).
Due to the subjective nature of disability glare and contrast sensitivity, it is fairly difficult to develop a reliable objective way to measure and quantify this phenomenon. One of the most commonly used clinical tests for disability glare is the Brightness Acuity Tester (BAT), which is described as an ice cream scooper 60 mm in diameter with a 12 mm hole in the center. With the patient viewing a visual acuity chart through the hole, a uniform luminance at three different settings-high (white sand beach), medium (clear day), low (overhead lighting)-is used to induce glare and simulate the various real-life conditions. The drop in visual acuity with the various glare settings is used as a measure of disability glare. The BAT test has been found to be a reliable predictor of outdoor visual acuity (clinically validated for use in measuring disability glare secondary to cataracts), is ubiquitously available, and is easy to administer. To further and more accurately reflect real life situations, it can be used in conjunction with a contrast sensitivity chart rather than the regular black-on-white Snellen letter chart (Aslam et al., 2007). Contrast sensitivity can be tested using letter-based charts (e.g. Pelli-Robson letter sensitivity chart) that consist of letters of the same size but with decreasing contrast, or contrast gratings, which are based on sinusoidal waves of light (e.g. Vistech MCT-8000 or FACT).
Opacification of the cornea in the form of scars or haze is a natural response to a wide array of pathological insults (e.g. infection, degeneration, corneal dystrophies) and can result in light scatter and glare. Measurement of corneal haze was previously crudely performed via standard slit-lamp examination and human measurement. Recently, an automated, non-invasive, and objective method to measure corneal scar density was introduced using Scheimpflug imaging. This Pentacam device (Oculus Optikgerate GmbH, Wetzlar, Germany) consists of a rotating camera that captures images of the cornea at an angle, and analysis of these anterior segment images can be employed to quantify scattered light in various diameters and depths of the cornea. The generated maps of the amount of scatter in different regions of the cornea are called corneal densitometry maps, and they are displayed along with maps of corneal topography (elevation) and pachymetry (thickness). Normative values for Scheimpflug densitometry have recently been established (Dhubhghaill et al., 2013). Measurements have also been obtained after various surgical procedures to analyze their impact on corneal clarity. This includes analysis of corneas after refractive surgery such as LASIK (Cennamo et al., 2011; Fares et al., 2012) and PRK (Takacs et al., 2011), as well as various forms of corneal transplantation (Koh et al., 2012; Bhatt et al., 2012; Arnalich-Montiel et al., 2013; Ivarsen \& Hjortdal, 2013) and collagen cross-linking (Gutierrez et al., 2012; Greenstein et al., 2010). Furthermore, it has been used to characterize pathological conditions including infectious keratitis (Otri et al., 2012; Orucoglu et al., 2014) and congenital corneal opacities (Elfein et al., 2013). However, no functional correlation has been made with these anatomical maps, and the relationship between scattered light as measured by densitometry and its effect on visual function such as contrast sensitivity and disability glare has not been well-characterized.
- Conditions
- Vision Disability
- Keywords
- Disability glare, Corneal scar, Corneal haze, Scheimpflug densitometry, Contrast sensitivity
- Medical subject headings
- Vision Disorders, Corneal Injuries, Corneal Opacity
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability glare
BAT measurements of disability glare
Measured: 1 year
Visual quality
NEI-VFQ25 questionnaire on functional visual quality
Measured: 1 year
Contrast sensitivity
Vistech contrast grating test
Measured: 1 year
Visual acuity
Visual acuity measured by Snellen chart
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2014 (estimated)
Why it stopped: Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Vision DisabilityStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe 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
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244892
- Sponsor's protocol ID
- IRB 04-14-30
- Status last verified
- Apr 2022
- First submitted
- 17 Sep 2014
- Last updated
- 13 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fan-Paul NI, Li J, Miller JS, Florakis GJ. Night vision disturbances after corneal refractive surgery. Surv Ophthalmol. 2002 Nov-Dec;47(6):533-46. doi: 10.1016/s0039-6257(02)00350-8.
PubMed 12504738Aslam TM, Haider D, Murray IJ. Principles of disability glare measurement: an ophthalmological perspective. Acta Ophthalmol Scand. 2007 Jun;85(4):354-60. doi: 10.1111/j.1600-0420.2006.00860.x. Epub 2007 Feb 20.
PubMed 17313443Lombardo M, Lombardo G. Wave aberration of human eyes and new descriptors of image optical quality and visual performance. J Cataract Refract Surg. 2010 Feb;36(2):313-31. doi: 10.1016/j.jcrs.2009.09.026.
PubMed 20152616Ni Dhubhghaill S, Rozema JJ, Jongenelen S, Ruiz Hidalgo I, Zakaria N, Tassignon MJ. Normative values for corneal densitometry analysis by Scheimpflug optical assessment. Invest Ophthalmol Vis Sci. 2014 Jan 7;55(1):162-8. doi: 10.1167/iovs.13-13236.
PubMed 24327608Cennamo G, Forte R, Aufiero B, La Rana A. Computerized Scheimpflug densitometry as a measure of corneal optical density after excimer laser refractive surgery in myopic eyes. J Cataract Refract Surg. 2011 Aug;37(8):1502-6. doi: 10.1016/j.jcrs.2011.03.037.
PubMed 21782093Fares U, Otri AM, Al-Aqaba MA, Faraj L, Dua HS. Wavefront-optimized excimer laser in situ keratomileusis for myopia and myopic astigmatism: refractive outcomes and corneal densitometry. J Cataract Refract Surg. 2012 Dec;38(12):2131-8. doi: 10.1016/j.jcrs.2012.07.041. Epub 2012 Oct 18.
PubMed 23084157Takacs AI, Mihaltz K, Nagy ZZ. Corneal density with the Pentacam after photorefractive keratectomy. J Refract Surg. 2011 Apr;27(4):269-77. doi: 10.3928/1081597X-20100618-02. Epub 2010 Jul 1.
PubMed 20672772Koh S, Maeda N, Nakagawa T, Nishida K. Quality of vision in eyes after selective lamellar keratoplasty. Cornea. 2012 Nov;31 Suppl 1:S45-9. doi: 10.1097/ICO.0b013e318269c9cd.
PubMed 23038035Bhatt UK, Fares U, Rahman I, Said DG, Maharajan SV, Dua HS. Outcomes of deep anterior lamellar keratoplasty following successful and failed 'big bubble'. Br J Ophthalmol. 2012 Apr;96(4):564-9. doi: 10.1136/bjophthalmol-2011-300214. Epub 2011 Dec 1.
PubMed 22133987Arnalich-Montiel F, Hernandez-Verdejo JL, Oblanca N, Munoz-Negrete FJ, De Miguel MP. Comparison of corneal haze and visual outcome in primary DSAEK versus DSAEK following failed DMEK. Graefes Arch Clin Exp Ophthalmol. 2013 Nov;251(11):2575-84. doi: 10.1007/s00417-013-2460-y. Epub 2013 Sep 6.
PubMed 24008847Ivarsen A, Hjortdal J. Recipient corneal thickness and visual outcome after Descemet's stripping automated endothelial keratoplasty. Br J Ophthalmol. 2014 Jan;98(1):30-4. doi: 10.1136/bjophthalmol-2013-304042. Epub 2013 Oct 16.
PubMed 24133026Gutierrez R, Lopez I, Villa-Collar C, Gonzalez-Meijome JM. Corneal transparency after cross-linking for keratoconus: 1-year follow-up. J Refract Surg. 2012 Nov;28(11):781-6. doi: 10.3928/1081597X-20121011-06.
PubMed 23347372Greenstein SA, Fry KL, Bhatt J, Hersh PS. Natural history of corneal haze after collagen crosslinking for keratoconus and corneal ectasia: Scheimpflug and biomicroscopic analysis. J Cataract Refract Surg. 2010 Dec;36(12):2105-14. doi: 10.1016/j.jcrs.2010.06.067.
PubMed 21111314Otri AM, Fares U, Al-Aqaba MA, Dua HS. Corneal densitometry as an indicator of corneal health. Ophthalmology. 2012 Mar;119(3):501-8. doi: 10.1016/j.ophtha.2011.08.024. Epub 2011 Nov 30.
PubMed 22133793Elflein HM, Hofherr T, Berisha-Ramadani F, Weyer V, Lampe C, Beck M, Pitz S. Measuring corneal clouding in patients suffering from mucopolysaccharidosis with the Pentacam densitometry programme. Br J Ophthalmol. 2013 Jul;97(7):829-33. doi: 10.1136/bjophthalmol-2012-302913. Epub 2013 May 17.
PubMed 23685998
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Scheimpflug Densitometry Measurements of Corneal Haze With Disability Glare
- ClinicalTrials.gov ID
- NCT02244892
- Acronym / sponsor ID
- IRB 04-14-30
- Conditions
- Vision Disability
- Keywords
- Disability glare, Corneal scar, Corneal haze, Scheimpflug densitometry, Contrast sensitivity
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2014 (estimated)
- First posted
- 19 Sep 2014 (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.
Disability glare is described as "halos" or "starbursts" around bright sources of light that can cause discomfort and reduce vision. The cornea is the clear "window" at the front of the eye, but certain conditions such as a previous infection can leave a scar. Corneal scars can cause disability glare by scattering and spreading incoming light instead of allowing it to focus on the back of the eye (retina) to get a crisp image. In this study, the corneal scar will be analyzed using a new device that measures scar density (Pentacam), and a relationship with disability glare will be made. This can help us further understand disability glare and make better decisions in the future on when to treat these scars to help patients see better.
Detailed description
Disability glare is a phenomenon commonly described as starbursts and halos that results in difficulty seeing clearly in the presence of bright "blinding" light. It can appear as if a veil of light is cast over the world outside. Optically, this occurs when incoming light is scattered in the eye instead of being focused on the retina. This is called straylight, and it diffusely illuminates the retina which causes desensitization of the photoreceptors and reduces the contrast of the retinal image (Lombardo \& Lombardo, 2010). The main sources of scatter in the human eye are opacities in the clear ocular media, primarily due to diffusion and loss of transparency in the cornea and lens, as well as within the retina. While the lens is the largest contributor to light scatter (especially with cataract formation and aging), opacification of the cornea (e.g. scars or haze) can similarly cause intraocular light scattering, resulting in disability glare and decreased contrast sensitivity (Fan-Paul et al., 2002).
Due to the subjective nature of disability glare and contrast sensitivity, it is fairly difficult to develop a reliable objective way to measure and quantify this phenomenon. One of the most commonly used clinical tests for disability glare is the Brightness Acuity Tester (BAT), which is described as an ice cream scooper 60 mm in diameter with a 12 mm hole in the center. With the patient viewing a visual acuity chart through the hole, a uniform luminance at three different settings-high (white sand beach), medium (clear day), low (overhead lighting)-is used to induce glare and simulate the various real-life conditions. The drop in visual acuity with the various glare settings is used as a measure of disability glare. The BAT test has been found to be a reliable predictor of outdoor visual acuity (clinically validated for use in measuring disability glare secondary to cataracts), is ubiquitously available, and is easy to administer. To further and more accurately reflect real life situations, it can be used in conjunction with a contrast sensitivity chart rather than the regular black-on-white Snellen letter chart (Aslam et al., 2007). Contrast sensitivity can be tested using letter-based charts (e.g. Pelli-Robson letter sensitivity chart) that consist of letters of the same size but with decreasing contrast, or contrast gratings, which are based on sinusoidal waves of light (e.g. Vistech MCT-8000 or FACT).
Opacification of the cornea in the form of scars or haze is a natural response to a wide array of pathological insults (e.g. infection, degeneration, corneal dystrophies) and can result in light scatter and glare. Measurement of corneal haze was previously crudely performed via standard slit-lamp examination and human measurement. Recently, an automated, non-invasive, and objective method to measure corneal scar density was introduced using Scheimpflug imaging. This Pentacam device (Oculus Optikgerate GmbH, Wetzlar, Germany) consists of a rotating camera that captures images of the cornea at an angle, and analysis of these anterior segment images can be employed to quantify scattered light in various diameters and depths of the cornea. The generated maps of the amount of scatter in different regions of the cornea are called corneal densitometry maps, and they are displayed along with maps of corneal topography (elevation) and pachymetry (thickness). Normative values for Scheimpflug densitometry have recently been established (Dhubhghaill et al., 2013). Measurements have also been obtained after various surgical procedures to analyze their impact on corneal clarity. This includes analysis of corneas after refractive surgery such as LASIK (Cennamo et al., 2011; Fares et al., 2012) and PRK (Takacs et al., 2011), as well as various forms of corneal transplantation (Koh et al., 2012; Bhatt et al., 2012; Arnalich-Montiel et al., 2013; Ivarsen \& Hjortdal, 2013) and collagen cross-linking (Gutierrez et al., 2012; Greenstein et al., 2010). Furthermore, it has been used to characterize pathological conditions including infectious keratitis (Otri et al., 2012; Orucoglu et al., 2014) and congenital corneal opacities (Elfein et al., 2013). However, no functional correlation has been made with these anatomical maps, and the relationship between scattered light as measured by densitometry and its effect on visual function such as contrast sensitivity and disability glare has not been well-characterized.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This will be a prospective study in which all eligible and willing patients will undergo the same workup. The expected duration is 1 year, and the trial will be stopped once the needed number of subjects has been enrolled. Testing will be performed on the day of the routine clinical visit and will only extend the appointment by less than 30 minutes. All patients receiving ophthalmological care at University Hospitals (both at the main Case Medical Center site and the satellite offices at Westlake and Landerbrook) who meet the inclusion and exclusion criteria would be eligible for this study. Subjects will be identified who have an isolated corneal scar in one eye and otherwise healthy eyes with no clinical evidence of lens or retinal pathology. Patients will be enrolled between September 6, 2014 and September 5, 2015, with the goal of recruiting at least 80-100 subjects.
Key inclusion criteria (3 listed)
- Age 18 years or greater
- Presence of corneal scar in one eye
- No clinical evidence of any other intraocular pathology
Key exclusion criteria (6 listed)
- Clinical evidence of other ocular pathology (e.g. cataracts)
- Pediatric patients less than 18 years old
- Bilateral corneal pathology
- Presence of active corneal inflammation/infection
- Presence of degenerative corneal disease
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
Disability glare
Time frame: 1 year
BAT measurements of disability glare
Visual quality
Time frame: 1 year
NEI-VFQ25 questionnaire on functional visual quality
Contrast sensitivity
Time frame: 1 year
Vistech contrast grating test
Visual acuity
Time frame: 1 year
Visual acuity measured by Snellen chart
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 13 Apr 2022.
- Background: PubMed 12504738Fan-Paul NI, Li J, Miller JS, Florakis GJ. Night vision disturbances after corneal refractive surgery. Surv Ophthalmol. 2002 Nov-Dec;47(6):533-46. doi: 10.1016/s0039-6257(02)00350-8.
- Background: PubMed 17313443Aslam TM, Haider D, Murray IJ. Principles of disability glare measurement: an ophthalmological perspective. Acta Ophthalmol Scand. 2007 Jun;85(4):354-60. doi: 10.1111/j.1600-0420.2006.00860.x. Epub 2007 Feb 20.
- Background: PubMed 20152616Lombardo M, Lombardo G. Wave aberration of human eyes and new descriptors of image optical quality and visual performance. J Cataract Refract Surg. 2010 Feb;36(2):313-31. doi: 10.1016/j.jcrs.2009.09.026.
- Background: PubMed 24327608Ni Dhubhghaill S, Rozema JJ, Jongenelen S, Ruiz Hidalgo I, Zakaria N, Tassignon MJ. Normative values for corneal densitometry analysis by Scheimpflug optical assessment. Invest Ophthalmol Vis Sci. 2014 Jan 7;55(1):162-8. doi: 10.1167/iovs.13-13236.
- Background: PubMed 21782093Cennamo G, Forte R, Aufiero B, La Rana A. Computerized Scheimpflug densitometry as a measure of corneal optical density after excimer laser refractive surgery in myopic eyes. J Cataract Refract Surg. 2011 Aug;37(8):1502-6. doi: 10.1016/j.jcrs.2011.03.037.
- Background: PubMed 23084157Fares U, Otri AM, Al-Aqaba MA, Faraj L, Dua HS. Wavefront-optimized excimer laser in situ keratomileusis for myopia and myopic astigmatism: refractive outcomes and corneal densitometry. J Cataract Refract Surg. 2012 Dec;38(12):2131-8. doi: 10.1016/j.jcrs.2012.07.041. Epub 2012 Oct 18.
- Background: PubMed 20672772Takacs AI, Mihaltz K, Nagy ZZ. Corneal density with the Pentacam after photorefractive keratectomy. J Refract Surg. 2011 Apr;27(4):269-77. doi: 10.3928/1081597X-20100618-02. Epub 2010 Jul 1.
- Background: PubMed 23038035Koh S, Maeda N, Nakagawa T, Nishida K. Quality of vision in eyes after selective lamellar keratoplasty. Cornea. 2012 Nov;31 Suppl 1:S45-9. doi: 10.1097/ICO.0b013e318269c9cd.
- Background: PubMed 22133987Bhatt UK, Fares U, Rahman I, Said DG, Maharajan SV, Dua HS. Outcomes of deep anterior lamellar keratoplasty following successful and failed 'big bubble'. Br J Ophthalmol. 2012 Apr;96(4):564-9. doi: 10.1136/bjophthalmol-2011-300214. Epub 2011 Dec 1.
- Background: PubMed 24008847Arnalich-Montiel F, Hernandez-Verdejo JL, Oblanca N, Munoz-Negrete FJ, De Miguel MP. Comparison of corneal haze and visual outcome in primary DSAEK versus DSAEK following failed DMEK. Graefes Arch Clin Exp Ophthalmol. 2013 Nov;251(11):2575-84. doi: 10.1007/s00417-013-2460-y. Epub 2013 Sep 6.
- Background: PubMed 24133026Ivarsen A, Hjortdal J. Recipient corneal thickness and visual outcome after Descemet's stripping automated endothelial keratoplasty. Br J Ophthalmol. 2014 Jan;98(1):30-4. doi: 10.1136/bjophthalmol-2013-304042. Epub 2013 Oct 16.
- Background: PubMed 23347372Gutierrez R, Lopez I, Villa-Collar C, Gonzalez-Meijome JM. Corneal transparency after cross-linking for keratoconus: 1-year follow-up. J Refract Surg. 2012 Nov;28(11):781-6. doi: 10.3928/1081597X-20121011-06.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Vision Disability, run by University Hospitals Cleveland Medical 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 3 inclusion and 6 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 13 Apr 2022. 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 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?
Disability glare (time frame: 1 year). The study lists 4 primary outcomes in all. 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 NCT02244892, which also lists 15 linked publications.
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 13 Apr 2022.