KeratoconusNCT03071302
Evaluation of Tomographic and Genetic Aspects of Keratoconus Patients Compared to Sounds Corneas
A study testing EVALUATION OF VSX1, SOD1, and TIMP3 genes in people with Keratoconus and Keratoconus, Unspecified, Bilateral, run by Sao Jose do Rio Preto Medical School at 1 site in Brazil.
Trial summary
Evaluation of tomographic (Pentacam) parameters and genetic parameters of Visual System Homeobox 1 (VSX1), Superoxide Dismutase (SOD1), Tissue Inhibitors of Metalloproteinases (TIMP3) genes of keratoconus patients diagnosed by clinical exam and topographic pattern. Read more about this study
- Who is it for?
- Ages 10 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Keratoconus, Keratoconus, Unspecified, Bilateral
- What is being tested?
- EVALUATION OF VSX1, SOD1, and TIMP3 genes
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2015to 31 Dec 2016
- Phase
- Interventional
- 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 10 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients diagnosed with keratoconus in clinical examination, topography and tomography
- Patients with clinical examination, topography, and tomography aspect of sound cornea in one eye, and the fellow eye diagnosed with keratoconus by clinical examination, topography, and tomography.
- Patients diagnosed with keratoconus by clinical examination, topography, and tomography in both eyes (OU).
- Patients with some degree of ametropia that underwent to PRK and LASIK
Who cannot join
- History of eye trauma, glaucoma, dysfunctional tear syndrome, rosacea, neurotrophic keratopathy, systemic or topical use of immunosuppressive drugs, previous ocular surgeries.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Visum Eye Center / Immunogenetic laboratory of FAMERP
São José do Rio Preto, São Paulo, 15015-020
About this study
Evaluation of tomographic (Pentacam) parameters and genetic parameters of Visual System Homeobox 1 (VSX1), Superoxide Dismutase (SOD1), Tissue Inhibitors of Metalloproteinases (TIMP3) genes of keratoconus patients diagnosed by clinical exam and topographic pattern. Basically we are screening patients that don't have keratoconus that those have keratoconus. The pentacam index of corneal curvature, thinnest point, corneal high order aberrations, posterior and anterior elevation, corneal densitometry, corneal volume were investigated. To analyze the genes, we took corneal epithelium samples of patients submitted to cross linking compared to (PRK) Photo Refractive Keratectomy ones. Also will be evaluated the genes of peripheral blood.
Read the detailed description
Keratoconus is a common disease that affects the cornea in both genders in all ethnic groups and that can manifest unilaterally or bilaterally in patients. Keratoconus due to a degenerative disease, its progression can be fast in various situations, affecting 1 in every 2,000 people, what results in severe structural changes of the cornea, which reduces its thickness and modify its normal curvature to a more conical shape. Keratoconus arises in adolescence and lasts for thirty to forty years of age, where it stabilizes and it is considered a major cause of corneal transplantation. Factors such as atopy, overuse of contact lenses and the act of rubbing the eyes are also related to the disease. The clinical picture consists of a lot of varied symptoms and it depends on the stage of disease progression. Currently it is known that genetic and environmental factors are involved in the desease emergence. Recently several genetic studies have aimed to identify mutations in genes which are directly linked to Keratoconus, such as VSX1, SOD1 and TIMP3 genes. However, despite the efforts directed towards the understanding of the genetic aspects of this disease, involving many genes, there are still many questions about the role of these genes in Keratoconus etiology. Thus, the present study aims to identify the presence of mutations in VSX1, SOD1 and TIMP3 genes, which are considered important candidates for the origin and development of this eye anomaly, through the analysis of their nucleotide sequences in corneal tissue and peripheral blood in Keratoconus patients, in their unilateral and bilateral forms. The results will allow to compare the presented mutations in different analysed tissues for unilateral and bilateral forms of Keratoconus and also compare them with the same tissues in healthy patients, in an attempt to establish what the likely inherited and/or acquired genetic mutations are causing this condition. Thus providing genetic data, still unpublished in Brazilian populations, which may offer subsidies for the characterization of the mutation dynamics and their patterns, on the origin and development of Keratoconus. Also will be evaluated the tomographic index as corneal curvature, thinnest point, corneal high order aberrations, posterior and anterior elevation, corneal densitometry, corneal volume. The idea is focused on that suspicious cornea that has the fellow eye with unequivocal keratoconus.
- Conditions
- Keratoconus, Keratoconus, Unspecified, Bilateral
- Being tested
- EVALUATION OF VSX1, SOD1, and TIMP3 genes
- Keywords
- Keratoconus,Corneal Dystrophies, corneal Tomography, topography
- Medical subject headings
- Keratoconus, Corneal Dystrophies, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVALUATION OF VSX1, SOD1, and TIMP3 genesOther
Also called pentacam and gene evaluation
Evaluation of VISX1, SOD1, TIMP3 genes in corneal epithelium, and in peripheral blood. Evaluation of pentacam parameters
| Study group | Role | What they receive |
|---|---|---|
| keratoconus | Active comparator | Evaluation of Visual System Homeobox 1 (VSX1), Superoxide Dismutase (SOD1), Tissue Inhibitors of Metalloproteinases (TIMP3) genes. Keratoconus with fellow eye without topographic and tomographic keratoconous pattern.Evaluation of tomographic datas. Sometimes we picked up the sample of corneal epithelium, and peripheral blood sample from corneal cross linking surgeries, in that case of keratoconus progression.
Group A Keratoconus/ like sound cornea. Group C Keratoconus / Keratoconus
Group C Keratoconus / Keratoconus Receives: Other: EVALUATION OF VSX1, SOD1, and TIMP3 genes |
| sound cornea | Placebo comparator | Evaluation of VSX1, SOD1, and TIMP3 genes. To analyze tomographic aspects, we evaluated the patients that underwent to LASIK (Lasei in situ Keratomileusis) with 2 year with follow up without any sign of ectasia To analyze the genes we picked up the sample of corneal epithelium, and peripheral blood sample from PRK (PhotoRefractive Keratectomy) surgeries. These patients showed topographic and tomographic normal pattern.
Group B Sound Cornea / Sound Cornea Receives: Other: EVALUATION OF VSX1, SOD1, and TIMP3 genes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the tomographic parameters of keratoconus, subclinical keratoconus in relation to sound corneas and identify the mutations present in the genes VSX1, SOD1 and TIMP3 in individuals affected by keratoconus.
The aim of this study was to evaluate Evaluate the tomographic parameters of keratoconus, subclinical keratoconus in relation to sound corneas and identify the mutations present in the genes VSX1, SOD1 and TIMP3 in individuals affected by keratoconus in several forms of manifestation.
Measured: 18 months
Secondary outcomes (2)
Tomographic parameters
Evaluating whether cross-referencing of known indexes may improve sensitivity and specificity in the detection of subclinical keratoconus;
- Evaluate if there is a correlation between the different tomographic indices; To evaluate the cornea densitometry in patients with keratoconus and its absence.
Measured: 18 months
Genetic evaluation, VISX1, SOD1, TIMP3
Avalue if after removal of the epithelium there is a very large change in the curvature, elevations and topometry of the cornea;
- Identify the presence of mutations in the VSX1, SOD1 and TIMP3 genes, from nucleotide sequence analysis in tissues of the affected cornea, normal cornea and peripheral blood, in patients with this pathology in their several forms.
- Compare the mutations present in the different tissues analyzed, for the unilateral and bilateral forms of keratoconus and also to compare them with the same tissues in healthy patients;
- Establish which are the probable inherited and / or acquired genetic mutations that cause this pathology, from the analysis of the same in the peripheral blood of the affected individuals.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2017
- Study start1 Aug 2015
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (97)Papers the sponsor has linked to this study.
- Other trials for KeratoconusStudies 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 N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sao Jose do Rio Preto Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Gildasio Castello de Almeida Junior, Sao Jose do Rio Preto Medical School
- Investigators
- Gildasio C Almeida Jr, MD, PhD, Principal investigator, FAMERP, Visum Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071302
- Sponsor's protocol ID
- CAAE 44071315.7.0000.5415
- Other IDs
- 2015/17226-7, 2015
- Status last verified
- Feb 2017
- First submitted
- 28 Feb 2017
- Last updated
- 6 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bisceglia L, De Bonis P, Pizzicoli C, Fischetti L, Laborante A, Di Perna M, Giuliani F, Delle Noci N, Buzzonetti L, Zelante L. Linkage analysis in keratoconus: replication of locus 5q21.2 and identification of other suggestive Loci. Invest Ophthalmol Vis Sci. 2009 Mar;50(3):1081-6. doi: 10.1167/iovs.08-2382. Epub 2008 Oct 31.
PubMed 18978346Karolak JA, Gajecka M. Genomic strategies to understand causes of keratoconus. Mol Genet Genomics. 2017 Apr;292(2):251-269. doi: 10.1007/s00438-016-1283-z. Epub 2016 Dec 28.
PubMed 28032277Li X, Yang H, Rabinowitz YS. Longitudinal study of keratoconus progression. Exp Eye Res. 2007 Oct;85(4):502-7. doi: 10.1016/j.exer.2007.06.016. Epub 2007 Jul 6.
PubMed 17681291Abu-Amero KK, Kalantan H, Al-Muammar AM. Analysis of the VSX1 gene in keratoconus patients from Saudi Arabia. Mol Vis. 2011 Mar 8;17:667-72.
PubMed 21403853Alio JL, Shabayek MH. Corneal higher order aberrations: a method to grade keratoconus. J Refract Surg. 2006 Jun;22(6):539-45. doi: 10.3928/1081-597X-20060601-05.
PubMed 16805116Ambrosio R Jr, Alonso RS, Luz A, Coca Velarde LG. Corneal-thickness spatial profile and corneal-volume distribution: tomographic indices to detect keratoconus. J Cataract Refract Surg. 2006 Nov;32(11):1851-9. doi: 10.1016/j.jcrs.2006.06.025.
PubMed 17081868Ambrosio R Jr, Caiado AL, Guerra FP, Louzada R, Sinha RA, Luz A, Dupps WJ, Belin MW. Novel pachymetric parameters based on corneal tomography for diagnosing keratoconus. J Refract Surg. 2011 Oct;27(10):753-8. doi: 10.3928/1081597X-20110721-01. Epub 2011 Jul 29.
PubMed 21800785Arnal E, Peris-Martinez C, Menezo JL, Johnsen-Soriano S, Romero FJ. Oxidative stress in keratoconus? Invest Ophthalmol Vis Sci. 2011 Nov 4;52(12):8592-7. doi: 10.1167/iovs.11-7732.
PubMed 21969298Bae GH, Kim JR, Kim CH, Lim DH, Chung ES, Chung TY. Corneal topographic and tomographic analysis of fellow eyes in unilateral keratoconus patients using Pentacam. Am J Ophthalmol. 2014 Jan;157(1):103-109.e1. doi: 10.1016/j.ajo.2013.08.014. Epub 2013 Oct 25.
PubMed 24452012Beckh U, Schonherr U, Naumann GO. [Autosomal dominant keratoconus as the chief ocular symptom in Lobstein osteogenesis imperfecta tarda]. Klin Monbl Augenheilkd. 1995 Apr;206(4):268-72. doi: 10.1055/s-2008-1035438. German.
PubMed 7791289Behndig A, Karlsson K, Johansson BO, Brannstrom T, Marklund SL. Superoxide dismutase isoenzymes in the normal and diseased human cornea. Invest Ophthalmol Vis Sci. 2001 Sep;42(10):2293-6.
PubMed 11527942Bardak H, Gunay M, Yildiz E, Bardak Y, Gunay B, Ozbas H, Bagci O. Novel visual system homeobox 1 gene mutations in Turkish patients with keratoconus. Genet Mol Res. 2016 Nov 3;15(4). doi: 10.4238/gmr15049024.
PubMed 27819732Bykhovskaya Y, Margines B, Rabinowitz YS. Genetics in Keratoconus: where are we? Eye Vis (Lond). 2016 Jun 27;3:16. doi: 10.1186/s40662-016-0047-5. eCollection 2016.
PubMed 27350955Chen D, Lam AK. Intrasession and intersession repeatability of the Pentacam system on posterior corneal assessment in the normal human eye. J Cataract Refract Surg. 2007 Mar;33(3):448-54. doi: 10.1016/j.jcrs.2006.11.008.
PubMed 17321396Chow RL, Volgyi B, Szilard RK, Ng D, McKerlie C, Bloomfield SA, Birch DG, McInnes RR. Control of late off-center cone bipolar cell differentiation and visual signaling by the homeobox gene Vsx1. Proc Natl Acad Sci U S A. 2004 Feb 10;101(6):1754-9. doi: 10.1073/pnas.0306520101. Epub 2004 Jan 26.
PubMed 14745032
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tomographic and Genetic Aspects of Keratoconus Patients Compared to Sounds Corneas
- ClinicalTrials.gov ID
- NCT03071302
- Acronym / sponsor ID
- CAAE 44071315.7.0000.5415
- Conditions
- Keratoconus, Keratoconus, Unspecified, Bilateral
- Keywords
- Keratoconus,Corneal Dystrophies, corneal Tomography, topography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Sao Jose do Rio Preto Medical SchoolUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 6 Mar 2017 (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.
Evaluation of tomographic (Pentacam) parameters and genetic parameters of Visual System Homeobox 1 (VSX1), Superoxide Dismutase (SOD1), Tissue Inhibitors of Metalloproteinases (TIMP3) genes of keratoconus patients diagnosed by clinical exam and topographic pattern. Basically we are screening patients that don't have keratoconus that those have keratoconus. The pentacam index of corneal curvature, thinnest point, corneal high order aberrations, posterior and anterior elevation, corneal densitometry, corneal volume were investigated. To analyze the genes, we took corneal epithelium samples of patients submitted to cross linking compared to (PRK) Photo Refractive Keratectomy ones. Also will be evaluated the genes of peripheral blood.
Detailed description
Keratoconus is a common disease that affects the cornea in both genders in all ethnic groups and that can manifest unilaterally or bilaterally in patients. Keratoconus due to a degenerative disease, its progression can be fast in various situations, affecting 1 in every 2,000 people, what results in severe structural changes of the cornea, which reduces its thickness and modify its normal curvature to a more conical shape. Keratoconus arises in adolescence and lasts for thirty to forty years of age, where it stabilizes and it is considered a major cause of corneal transplantation. Factors such as atopy, overuse of contact lenses and the act of rubbing the eyes are also related to the disease. The clinical picture consists of a lot of varied symptoms and it depends on the stage of disease progression. Currently it is known that genetic and environmental factors are involved in the desease emergence. Recently several genetic studies have aimed to identify mutations in genes which are directly linked to Keratoconus, such as VSX1, SOD1 and TIMP3 genes. However, despite the efforts directed towards the understanding of the genetic aspects of this disease, involving many genes, there are still many questions about the role of these genes in Keratoconus etiology. Thus, the present study aims to identify the presence of mutations in VSX1, SOD1 and TIMP3 genes, which are considered important candidates for the origin and development of this eye anomaly, through the analysis of their nucleotide sequences in corneal tissue and peripheral blood in Keratoconus patients, in their unilateral and bilateral forms. The results will allow to compare the presented mutations in different analysed tissues for unilateral and bilateral forms of Keratoconus and also compare them with the same tissues in healthy patients, in an attempt to establish what the likely inherited and/or acquired genetic mutations are causing this condition. Thus providing genetic data, still unpublished in Brazilian populations, which may offer subsidies for the characterization of the mutation dynamics and their patterns, on the origin and development of Keratoconus. Also will be evaluated the tomographic index as corneal curvature, thinnest point, corneal high order aberrations, posterior and anterior elevation, corneal densitometry, corneal volume. The idea is focused on that suspicious cornea that has the fellow eye with unequivocal keratoconus.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| keratoconus | Active comparator | Other: EVALUATION OF VSX1, SOD1, and TIMP3 genesEvaluation of Visual System Homeobox 1 (VSX1), Superoxide Dismutase (SOD1), Tissue Inhibitors of Metalloproteinases (TIMP3) genes. Keratoconus with fellow eye without topographic and tomographic keratoconous pattern.Evaluation of tomographic datas. Sometimes we picked up the sample of corneal epithelium, and peripheral blood sample from corneal cross linking surgeries, in that case of keratoconus progression. Group A Keratoconus/ like sound cornea. Group C Keratoconus / Keratoconus Group C Keratoconus / Keratoconus |
| sound cornea | Placebo comparator | Other: EVALUATION OF VSX1, SOD1, and TIMP3 genesEvaluation of VSX1, SOD1, and TIMP3 genes. To analyze tomographic aspects, we evaluated the patients that underwent to LASIK (Lasei in situ Keratomileusis) with 2 year with follow up without any sign of ectasia To analyze the genes we picked up the sample of corneal epithelium, and peripheral blood sample from PRK (PhotoRefractive Keratectomy) surgeries. These patients showed topographic and tomographic normal pattern. Group B Sound Cornea / Sound Cornea |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients diagnosed with keratoconus in clinical examination, topography and tomography
- Patients with clinical examination, topography, and tomography aspect of sound cornea in one eye, and the fellow eye diagnosed with keratoconus by clinical examination, topography, and tomography.
- Patients diagnosed with keratoconus by clinical examination, topography, and tomography in both eyes (OU).
- Patients with some degree of ametropia that underwent to PRK and LASIK
Key exclusion criteria (1 listed)
- History of eye trauma, glaucoma, dysfunctional tear syndrome, rosacea, neurotrophic keratopathy, systemic or topical use of immunosuppressive drugs, previous ocular surgeries.
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 |
|---|---|---|
| EVALUATION OF VSX1, SOD1, and TIMP3 genesAlso: pentacam and gene evaluationEvaluation of VISX1, SOD1, TIMP3 genes in corneal epithelium, and in peripheral blood. Evaluation of pentacam parameters | Other | keratoconus, sound cornea |
Primary outcome
Evaluate the tomographic parameters of keratoconus, subclinical keratoconus in relation to sound corneas and identify the mutations present in the genes VSX1, SOD1 and TIMP3 in individuals affected by keratoconus.
Time frame: 18 months
The aim of this study was to evaluate Evaluate the tomographic parameters of keratoconus, subclinical keratoconus in relation to sound corneas and identify the mutations present in the genes VSX1, SOD1 and TIMP3 in individuals affected by keratoconus in several forms of manifestation.
2 secondary outcomes
Tomographic parameters
Time frame: 18 months
Genetic evaluation, VISX1, SOD1, TIMP3
Time frame: 18 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 6 Mar 2017.
- Background: PubMed 18978346Bisceglia L, De Bonis P, Pizzicoli C, Fischetti L, Laborante A, Di Perna M, Giuliani F, Delle Noci N, Buzzonetti L, Zelante L. Linkage analysis in keratoconus: replication of locus 5q21.2 and identification of other suggestive Loci. Invest Ophthalmol Vis Sci. 2009 Mar;50(3):1081-6. doi: 10.1167/iovs.08-2382. Epub 2008 Oct 31.
- Background: PubMed 28032277Karolak JA, Gajecka M. Genomic strategies to understand causes of keratoconus. Mol Genet Genomics. 2017 Apr;292(2):251-269. doi: 10.1007/s00438-016-1283-z. Epub 2016 Dec 28.
- Results publication: PubMed 17681291Li X, Yang H, Rabinowitz YS. Longitudinal study of keratoconus progression. Exp Eye Res. 2007 Oct;85(4):502-7. doi: 10.1016/j.exer.2007.06.016. Epub 2007 Jul 6.
- Results publication: PubMed 21403853Abu-Amero KK, Kalantan H, Al-Muammar AM. Analysis of the VSX1 gene in keratoconus patients from Saudi Arabia. Mol Vis. 2011 Mar 8;17:667-72.
- Results publication: PubMed 16805116Alio JL, Shabayek MH. Corneal higher order aberrations: a method to grade keratoconus. J Refract Surg. 2006 Jun;22(6):539-45. doi: 10.3928/1081-597X-20060601-05.
- Results publication: PubMed 17081868Ambrosio R Jr, Alonso RS, Luz A, Coca Velarde LG. Corneal-thickness spatial profile and corneal-volume distribution: tomographic indices to detect keratoconus. J Cataract Refract Surg. 2006 Nov;32(11):1851-9. doi: 10.1016/j.jcrs.2006.06.025.
- Results publication: PubMed 21800785Ambrosio R Jr, Caiado AL, Guerra FP, Louzada R, Sinha RA, Luz A, Dupps WJ, Belin MW. Novel pachymetric parameters based on corneal tomography for diagnosing keratoconus. J Refract Surg. 2011 Oct;27(10):753-8. doi: 10.3928/1081597X-20110721-01. Epub 2011 Jul 29.
- Results publication: PubMed 21969298Arnal E, Peris-Martinez C, Menezo JL, Johnsen-Soriano S, Romero FJ. Oxidative stress in keratoconus? Invest Ophthalmol Vis Sci. 2011 Nov 4;52(12):8592-7. doi: 10.1167/iovs.11-7732.
- Results publication: PubMed 24452012Bae GH, Kim JR, Kim CH, Lim DH, Chung ES, Chung TY. Corneal topographic and tomographic analysis of fellow eyes in unilateral keratoconus patients using Pentacam. Am J Ophthalmol. 2014 Jan;157(1):103-109.e1. doi: 10.1016/j.ajo.2013.08.014. Epub 2013 Oct 25.
- Results publication: PubMed 7791289Beckh U, Schonherr U, Naumann GO. [Autosomal dominant keratoconus as the chief ocular symptom in Lobstein osteogenesis imperfecta tarda]. Klin Monbl Augenheilkd. 1995 Apr;206(4):268-72. doi: 10.1055/s-2008-1035438. German.
- Results publication: PubMed 11527942Behndig A, Karlsson K, Johansson BO, Brannstrom T, Marklund SL. Superoxide dismutase isoenzymes in the normal and diseased human cornea. Invest Ophthalmol Vis Sci. 2001 Sep;42(10):2293-6.
- Results publication: PubMed 27819732Bardak H, Gunay M, Yildiz E, Bardak Y, Gunay B, Ozbas H, Bagci O. Novel visual system homeobox 1 gene mutations in Turkish patients with keratoconus. Genet Mol Res. 2016 Nov 3;15(4). doi: 10.4238/gmr15049024.
- Individual participant dataSharing planned: Undecided
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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.
Gildasio C Almeida Jr, MD, PhD principal investigator
FAMERP, Visum Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EVALUATION OF VSX1, SOD1, and TIMP3 genes in people with Keratoconus and Keratoconus, Unspecified, Bilateral, run by Sao Jose do Rio Preto Medical School at 1 site in Brazil.
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 4 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 6 Mar 2017. 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 Brazil. 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.
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?
Evaluate the tomographic parameters of keratoconus, subclinical keratoconus in relation to sound corneas and identify the mutations present in the genes VSX1, SOD1 and TIMP3 in individuals affected by keratoconus. (time frame: 18 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 NCT03071302, which also lists 97 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 6 Mar 2017.