GlaucomaPhase 4NCT04676126
Augmented Macular Pigment-containing Nutraceutical and Central Visual Function
A Phase 4 study testing Lumega-Z and Dorzolamide Hcl 2% Oph Soln in people with Glaucoma and Glaucoma Eye, run by University of the Incarnate Word at 1 site in United States.
Trial summary
The purpose of this study is to prospectively analyze changes in macular pigment optical density and dermal carotenoid levels as they relate to visual field function in patients prescribed a macular pigment-containing medical food (Lumega-Z), in combination with a topical carbonic anhydrase inhibitor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Glaucoma Eye, Glaucoma, Open-Angle
- What is being tested?
- Lumega-Z and Dorzolamide Hcl 2% Oph Soln
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2021to May 2022
- 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
- Age ≥ 18 years
- Glaucoma diagnosis (H40. *) with abnormal visual field as measured by 30-2 Humphrey Perimetry (mean deviation < -2.00)
- Adequate IOP control (IOP > 7 mmHg and < 22 mmHg) by medical or surgical means measured by Goldman Applanation Tonometry for at least 3 months
- Visual field progression - decrease (more negative) in MD by 1.00 dB or more when compared to prior HVF)
- Refractive error ≤ 10 diopters and astigmatism ≤ 3 diopters
Who cannot join
- BCVA worse than 20/200
- Pt Is unable to tolerate MPOD, CS, dermal carotenoid measurement-taking procedures
- Loss of IOP control requires surgical intervention
- Patient already taking AREDS formula oral supplement
- Patient taking medication or dietary supplements that may interact with LM ingredients
- History of photosensitive epilepsy
Show all 14Show fewer
- History of penetrating ocular trauma or vitrectomy
- History of ocular or orbital radiation therapy or is currently receiving chemotherapy
- Women who are nursing, pregnant, or are planning pregnancy
- Has a known adverse reaction (including sulfa allergy) and/or sensitivity to the study supplement or its ingredients including: N-acetyl-cysteine, acetyl-L-carnitine, L-taurine, quercetin, Co-enzyme Q-10, lutein, meso zeaxanthin, zeaxanthin, astazanthin, lycopene, alpha-lipoic acid.
- Currently enrolled in an investigational drug study or has used an investigational drug within 30 days prior to recruitment.
- Is planning on having ocular surgery at any time throughout the study duration, or had ocular surgery < 3 months before enrollment
- Native lens opacity ≥ grade 3 on ARLNS standard photograph
- Blue light filter intraocular lens
Trial locations and contacts
1 site in 1 country.
United States1 site
Ophtalmology Clinic of William E Sponsel
San Antonio, Texas, 78215
About this study
Official title: Augmented Macular Pigment Supplement and Pericentral Visual Function: a Randomized Controlled Trial
The purpose of this study is to prospectively analyze changes in macular pigment optical density and dermal carotenoid levels as they relate to visual field function in patients prescribed a macular pigment-containing medical food (Lumega-Z), in combination with a topical carbonic anhydrase inhibitor.
Read the detailed description
This is a prospective double-masked, randomized controlled trial which evaluates central visual field function as it relates to macular pigment optical density, contrast sensitivity, and dermal carotenoid levels in the presence of a commercial macular pigment-containing medical food (Lumega-Z). Participants will be randomized to twelve weeks of supplement + dorzolamide or twelve weeks of placebo. All packaging of supplement and dorzolamide and the placebo will be identical and distributed by a third party. Both subjects and the investigators examining patients will be masked to placebo and experimental group assignment.
- Conditions
- Glaucoma, Glaucoma Eye, Glaucoma, Open-Angle
- Being tested
- Lumega-Z, Dorzolamide Hcl 2% Oph Soln, Placebo
- Keywords
- Lumega-Z, Macular Pigment, Macular Pigment Optical Density, Contrast Sensitivity, Humphrey Visual Field 10-2, Dermal Carotenoid, MapcatSF, Veggie Meter, Vector Vision, Pericentral Visual Field
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumega-ZDietary supplement
Medical food which contains lutein, zeaxanthin, and meso-zeaxanthin
Dorzolamide Hcl 2% Oph SolnDrug
Also called Azopt
Topical carbonic anhydrase inhibitor
PlaceboOther
Specially formulated non macular pigment-containing formulation which tastes similar to the commercial medical food being evaluated in this study
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Subjects in the experimental arm will consume 1.5 Tbsp (22.2 mL) of a commercial macular pigment-containing medical food (liquid) once per day and use a carbonic anhydrase inhibitor topical eye drop (2% dorzolamide ophthalmic solution) three times per day in both eyes for 3 months. Receives: Dietary Supplement: Lumega-Z; Drug: Dorzolamide Hcl 2% Oph Soln |
| Placebo | Placebo comparator | Subjects in the placebo arm will consume 1.5 Tbsp (22.2 mL) of a placebo liquid which resembles the commercial macular pigment-containing medical food (liquid) in taste once per day and use a lubricating eye drop (0.5% sodium + 0.9% glycerin ophthalmic solution) three times per day in both eyes for 3 months. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pericentral Visual Function
Mean deviation and pattern standard deviation of 10-2 Humphrey visual field
Measured: 3 Months
Secondary outcomes (3)
Macular Pigment Optical Density
Macular Pigment Optical Density measured by Mapcat SF
Measured: Monthly for 3 months
Dermal Carotenoid Levels
Measured by Veggie Meter
Measured: Monthly for 3 months
Contrast Sensitivity
Measured by Vector Vision CSV-2000
Measured: Monthly for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study startMay 2021 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
Why it stopped: IRB records show administrative closure on 12/16/21. No subjects enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective double-masked, randomized controlled study which compares pre- supplementation macular pigment optical density, contrast sensitivity, dermal carotenoid levels, and visual field status to post-supplement measurements of the same.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Incarnate Word
- Sponsor type
- University, hospital or other
- Collaborators
- Guardion Health Sciences, Inc.
- Responsible party
- Sponsor
- Investigators
- Grant T Slagle, DO, Principal investigator, Sponsel Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676126
- Sponsor's protocol ID
- 20-11-005
- Status last verified
- Sep 2022
- First submitted
- 9 Dec 2020
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD to other researches.
Publications
Bone RA, Davey PG, Roman BO, Evans DW. Efficacy of Commercially Available Nutritional Supplements: Analysis of Serum Uptake, Macular Pigment Optical Density and Visual Functional Response. Nutrients. 2020 May 6;12(5):1321. doi: 10.3390/nu12051321.
PubMed 32384663Ma L, Liu R, Du JH, Liu T, Wu SS, Liu XH. Lutein, Zeaxanthin and Meso-zeaxanthin Supplementation Associated with Macular Pigment Optical Density. Nutrients. 2016 Jul 12;8(7):426. doi: 10.3390/nu8070426.
PubMed 27420092Power R, Coen RF, Beatty S, Mulcahy R, Moran R, Stack J, Howard AN, Nolan JM. Supplemental Retinal Carotenoids Enhance Memory in Healthy Individuals with Low Levels of Macular Pigment in A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. J Alzheimers Dis. 2018;61(3):947-961. doi: 10.3233/JAD-170713.
PubMed 29332050Jahns L, Johnson LK, Mayne ST, Cartmel B, Picklo MJ Sr, Ermakov IV, Gellermann W, Whigham LD. Skin and plasma carotenoid response to a provided intervention diet high in vegetables and fruit: uptake and depletion kinetics. Am J Clin Nutr. 2014 Sep;100(3):930-7. doi: 10.3945/ajcn.114.086900. Epub 2014 Jul 9.
PubMed 25008856Jahns L, Johnson LK, Conrad Z, Bukowski M, Raatz SK, Jilcott Pitts S, Wang Y, Ermakov IV, Gellermann W. Concurrent validity of skin carotenoid status as a concentration biomarker of vegetable and fruit intake compared to multiple 24-h recalls and plasma carotenoid concentrations across one year: a cohort study. Nutr J. 2019 Nov 21;18(1):78. doi: 10.1186/s12937-019-0500-0.
PubMed 31752882Conrady CD, Bell JP, Besch BM, Gorusupudi A, Farnsworth K, Ermakov I, Sharifzadeh M, Ermakova M, Gellermann W, Bernstein PS. Correlations Between Macular, Skin, and Serum Carotenoids. Invest Ophthalmol Vis Sci. 2017 Jul 1;58(9):3616-3627. doi: 10.1167/iovs.17-21818.
PubMed 28728169Ermakov IV, Gellermann W. Dermal carotenoid measurements via pressure mediated reflection spectroscopy. J Biophotonics. 2012 Jul;5(7):559-70. doi: 10.1002/jbio.201100122. Epub 2012 Feb 13.
PubMed 22331637Sponsel WE, Harrison J, Elliott WR, Trigo Y, Kavanagh J, Harris A. Dorzolamide hydrochloride and visual function in normal eyes. Am J Ophthalmol. 1997 Jun;123(6):759-66. doi: 10.1016/s0002-9394(14)71124-9.
PubMed 9535619Bone RA, Landrum JT, Hime GW, Cains A, Zamor J. Stereochemistry of the human macular carotenoids. Invest Ophthalmol Vis Sci. 1993 May;34(6):2033-40.
PubMed 8491553Britton G. Structure and properties of carotenoids in relation to function. FASEB J. 1995 Dec;9(15):1551-8.
PubMed 8529834Age-Related Eye Disease Study 2 (AREDS2) Research Group; Chew EY, Clemons TE, Sangiovanni JP, Danis RP, Ferris FL 3rd, Elman MJ, Antoszyk AN, Ruby AJ, Orth D, Bressler SB, Fish GE, Hubbard GB, Klein ML, Chandra SR, Blodi BA, Domalpally A, Friberg T, Wong WT, Rosenfeld PJ, Agron E, Toth CA, Bernstein PS, Sperduto RD. Secondary analyses of the effects of lutein/zeaxanthin on age-related macular degeneration progression: AREDS2 report No. 3. JAMA Ophthalmol. 2014 Feb;132(2):142-9. doi: 10.1001/jamaophthalmol.2013.7376.
PubMed 24310343Aronow ME, Chew EY. Age-related Eye Disease Study 2: perspectives, recommendations, and unanswered questions. Curr Opin Ophthalmol. 2014 May;25(3):186-90. doi: 10.1097/ICU.0000000000000046.
PubMed 24614146Akuffo KO, Beatty S, Peto T, Stack J, Stringham J, Kelly D, Leung I, Corcoran L, Nolan JM. The Impact of Supplemental Antioxidants on Visual Function in Nonadvanced Age-Related Macular Degeneration: A Head-to-Head Randomized Clinical Trial. Invest Ophthalmol Vis Sci. 2017 Oct 1;58(12):5347-5360. doi: 10.1167/iovs.16-21192.
PubMed 29053808Nakano Y, Hirooka K, Chiba Y, Ueno M, Ojima D, Hossain MR, Takahashi H, Yamamoto T, Kiuchi Y. Retinal ganglion cell loss in kinesin-1 cargo Alcadein alpha deficient mice. Cell Death Dis. 2020 Mar 3;11(3):166. doi: 10.1038/s41419-020-2363-x.
PubMed 32127528Quigley HA. Glaucoma. Lancet. 2011 Apr 16;377(9774):1367-77. doi: 10.1016/S0140-6736(10)61423-7. Epub 2011 Mar 30.
PubMed 21453963
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Macular Pigment Supplement and Pericentral Visual Function: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04676126
- Acronym / sponsor ID
- 20-11-005
- Conditions
- Glaucoma, Glaucoma Eye, Glaucoma, Open-Angle
- Keywords
- Lumega-Z, Macular Pigment, Macular Pigment Optical Density, Contrast Sensitivity, Humphrey Visual Field 10-2, Dermal Carotenoid, MapcatSF, Veggie Meter
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IRB records show administrative closure on 12/16/21. No subjects enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of the Incarnate WordUniversity, hospital or other
- Collaborators
- Guardion Health Sciences, Inc.
- Study start
- May 2021 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 19 Dec 2020 (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 purpose of this study is to prospectively analyze changes in macular pigment optical density and dermal carotenoid levels as they relate to visual field function in patients prescribed a macular pigment-containing medical food (Lumega-Z), in combination with a topical carbonic anhydrase inhibitor.
Detailed description
This is a prospective double-masked, randomized controlled trial which evaluates central visual field function as it relates to macular pigment optical density, contrast sensitivity, and dermal carotenoid levels in the presence of a commercial macular pigment-containing medical food (Lumega-Z). Participants will be randomized to twelve weeks of supplement + dorzolamide or twelve weeks of placebo. All packaging of supplement and dorzolamide and the placebo will be identical and distributed by a third party. Both subjects and the investigators examining patients will be masked to placebo and experimental group assignment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a prospective double-masked, randomized controlled study which compares pre- supplementation macular pigment optical density, contrast sensitivity, dermal carotenoid levels, and visual field status to post-supplement measurements of the same.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Dietary Supplement: Lumega-Z, Drug: Dorzolamide Hcl 2% Oph SolnSubjects in the experimental arm will consume 1.5 Tbsp (22.2 mL) of a commercial macular pigment-containing medical food (liquid) once per day and use a carbonic anhydrase inhibitor topical eye drop (2% dorzolamide ophthalmic solution) three times per day in both eyes for 3 months. |
| Placebo | Placebo comparator | Other: PlaceboSubjects in the placebo arm will consume 1.5 Tbsp (22.2 mL) of a placebo liquid which resembles the commercial macular pigment-containing medical food (liquid) in taste once per day and use a lubricating eye drop (0.5% sodium + 0.9% glycerin ophthalmic solution) three times per day in both eyes for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Glaucoma diagnosis (H40. *) with abnormal visual field as measured by 30-2 Humphrey Perimetry (mean deviation < -2.00)
- Adequate IOP control (IOP > 7 mmHg and < 22 mmHg) by medical or surgical means measured by Goldman Applanation Tonometry for at least 3 months
- Visual field progression - decrease (more negative) in MD by 1.00 dB or more when compared to prior HVF)
- Refractive error ≤ 10 diopters and astigmatism ≤ 3 diopters
Key exclusion criteria (14 listed)
- BCVA worse than 20/200
- Pt Is unable to tolerate MPOD, CS, dermal carotenoid measurement-taking procedures
- Loss of IOP control requires surgical intervention
- Patient already taking AREDS formula oral supplement
- Patient taking medication or dietary supplements that may interact with LM ingredients
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 |
|---|---|---|
| Lumega-ZMedical food which contains lutein, zeaxanthin, and meso-zeaxanthin | Dietary supplement | Experimental |
| Dorzolamide Hcl 2% Oph SolnAlso: AzoptTopical carbonic anhydrase inhibitor | Drug | Experimental |
| PlaceboSpecially formulated non macular pigment-containing formulation which tastes similar to the commercial medical food being evaluated in this study | Other | Placebo |
Primary outcome
Pericentral Visual Function
Time frame: 3 Months
Mean deviation and pattern standard deviation of 10-2 Humphrey visual field
3 secondary outcomes
Macular Pigment Optical Density
Time frame: Monthly for 3 months
Dermal Carotenoid Levels
Time frame: Monthly for 3 months
Contrast Sensitivity
Time frame: Monthly for 3 months
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 4 Oct 2022.
- Background: PubMed 32384663Bone RA, Davey PG, Roman BO, Evans DW. Efficacy of Commercially Available Nutritional Supplements: Analysis of Serum Uptake, Macular Pigment Optical Density and Visual Functional Response. Nutrients. 2020 May 6;12(5):1321. doi: 10.3390/nu12051321.
- Background: PubMed 27420092Ma L, Liu R, Du JH, Liu T, Wu SS, Liu XH. Lutein, Zeaxanthin and Meso-zeaxanthin Supplementation Associated with Macular Pigment Optical Density. Nutrients. 2016 Jul 12;8(7):426. doi: 10.3390/nu8070426.
- Background: PubMed 29332050Power R, Coen RF, Beatty S, Mulcahy R, Moran R, Stack J, Howard AN, Nolan JM. Supplemental Retinal Carotenoids Enhance Memory in Healthy Individuals with Low Levels of Macular Pigment in A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. J Alzheimers Dis. 2018;61(3):947-961. doi: 10.3233/JAD-170713.
- Background: PubMed 25008856Jahns L, Johnson LK, Mayne ST, Cartmel B, Picklo MJ Sr, Ermakov IV, Gellermann W, Whigham LD. Skin and plasma carotenoid response to a provided intervention diet high in vegetables and fruit: uptake and depletion kinetics. Am J Clin Nutr. 2014 Sep;100(3):930-7. doi: 10.3945/ajcn.114.086900. Epub 2014 Jul 9.
- Background: PubMed 31752882Jahns L, Johnson LK, Conrad Z, Bukowski M, Raatz SK, Jilcott Pitts S, Wang Y, Ermakov IV, Gellermann W. Concurrent validity of skin carotenoid status as a concentration biomarker of vegetable and fruit intake compared to multiple 24-h recalls and plasma carotenoid concentrations across one year: a cohort study. Nutr J. 2019 Nov 21;18(1):78. doi: 10.1186/s12937-019-0500-0.
- Background: PubMed 28728169Conrady CD, Bell JP, Besch BM, Gorusupudi A, Farnsworth K, Ermakov I, Sharifzadeh M, Ermakova M, Gellermann W, Bernstein PS. Correlations Between Macular, Skin, and Serum Carotenoids. Invest Ophthalmol Vis Sci. 2017 Jul 1;58(9):3616-3627. doi: 10.1167/iovs.17-21818.
- Background: PubMed 22331637Ermakov IV, Gellermann W. Dermal carotenoid measurements via pressure mediated reflection spectroscopy. J Biophotonics. 2012 Jul;5(7):559-70. doi: 10.1002/jbio.201100122. Epub 2012 Feb 13.
- Background: PubMed 9535619Sponsel WE, Harrison J, Elliott WR, Trigo Y, Kavanagh J, Harris A. Dorzolamide hydrochloride and visual function in normal eyes. Am J Ophthalmol. 1997 Jun;123(6):759-66. doi: 10.1016/s0002-9394(14)71124-9.
- Background: PubMed 8491553Bone RA, Landrum JT, Hime GW, Cains A, Zamor J. Stereochemistry of the human macular carotenoids. Invest Ophthalmol Vis Sci. 1993 May;34(6):2033-40.
- Background: PubMed 8529834Britton G. Structure and properties of carotenoids in relation to function. FASEB J. 1995 Dec;9(15):1551-8.
- Background: PubMed 24310343Age-Related Eye Disease Study 2 (AREDS2) Research Group; Chew EY, Clemons TE, Sangiovanni JP, Danis RP, Ferris FL 3rd, Elman MJ, Antoszyk AN, Ruby AJ, Orth D, Bressler SB, Fish GE, Hubbard GB, Klein ML, Chandra SR, Blodi BA, Domalpally A, Friberg T, Wong WT, Rosenfeld PJ, Agron E, Toth CA, Bernstein PS, Sperduto RD. Secondary analyses of the effects of lutein/zeaxanthin on age-related macular degeneration progression: AREDS2 report No. 3. JAMA Ophthalmol. 2014 Feb;132(2):142-9. doi: 10.1001/jamaophthalmol.2013.7376.
- Background: PubMed 24614146Aronow ME, Chew EY. Age-related Eye Disease Study 2: perspectives, recommendations, and unanswered questions. Curr Opin Ophthalmol. 2014 May;25(3):186-90. doi: 10.1097/ICU.0000000000000046.
- Individual participant dataSharing planned: No. There is no plan to share IPD to other researches.
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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.
Grant T Slagle, DO principal investigator
Sponsel Foundation
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 Lumega-Z and Dorzolamide Hcl 2% Oph Soln in people with Glaucoma and Glaucoma Eye, run by University of the Incarnate Word 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 5 inclusion and 14 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 4 Oct 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. Some participants in this study may receive a placebo. 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?
Pericentral Visual Function (time frame: 3 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 NCT04676126, which also lists 30 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 4 Oct 2022.