KeratoconusNCT04433936

Corneal Tomographic Parameters in TGD

An observational study of Keratoconus and Corneal Ectasia, run by Ameera Gamal Abdelhameed at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The current study involved analysis of the corneal tomographic parameters of patients with thyroid gland dysfunction (hyperthyroidism or hypothyroidism), including those with an autoimmune etiology, in comparison to healthy controls without TGD, using pentacam, in an attempt to detect possible early corneal changes… Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Keratoconus, Corneal Ectasia, Thyroid Eye Disease
What is being tested?: Pentacam tomography
How many people: 100 participants
Where: 1 siteEgypt
Study dates: 1 Feb 2018to 1 Jun 2018
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Study population: 100 eyes of 50 patients with TGD (hypo-hyperthyroidism) and 100 eyes of 50 age and sex matched healthy controls.

Who may be able to join

For TGD patients: Patients with a recent diagnosis of TGD (the study group) were recruited from endocrinology outpatient clinic of Specialized Medical Hospital, Mansoura University. Diagnosis of TGD was based on précised history, clinical examination and laboratory investigations. In order to avoid bias, patients with history of intake of any thyroid-related medications (antithyroid medications or thyroxine replacement), radioactive iodine or thyroidectomy were excluded from the study. Therefore, we only included patients who did not received treatment yet For the control group, fifty age and gender matched healthy subjects without known personal or family history of thyroid disease or any autoimmune diseases were recruited from candidates of refractive surgery referred to the outpatient clinic of Mansoura Ophthalmology Center for pentacam assessment and who were proved to have normal corneal pentacam parameters. They were further examined by the endocrinologist to exclude thyroid dysfunction; this was supported by normal thyroid function profile (serum TSH and free T4) and negative anti-TPO and antithyroglobulin antibodies.

Who cannot join

patients with previous thyroid medications or replacement therapy, thyroidectomy or radioactive iodine intake participants with a history of ocular surgery or trauma, use of any topical medication or contact lens wear, patients with any corneal pathology, Corneal dystrophy, corneal scarring or any concurrent ocular disease. To eliminate other risk factors for KC, we also excluded participants with a history of persistent eye rubbing, vernal keratoconjunctivitis (VKC), atopy, Down syndrome, Turner's syndrome, or congenital rubella. Pregnant or lactating females were also excluded from the study.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Mansoura University
Al Mansurah, Dakahlia Governorate

Other trials in Egypt

About this study

Official title: Corneal Tomographic Analysis Among Patients With Thyroid Gland Dysfunction.

Read the detailed description

A total of 100 eyes of 50 patients with TGD and 100 eyes of 50 healthy controls were enrolled. Diagnosis of TGD was based on history, clinical examination and laboratory investigations. Exclusion criteria included previous thyroid medications, thyroidectomy, previous ocular surgery, corneal pathology and other risk factors of keratoconus (KC). All eyes were examined by Pentacam, (Oculus Optikgerate GmbH, Wetzlar, Germany). Pentacam parameters were compared between TGD patients and controls. Spearman's correlation coefficient between different pentacam parameters and the level of free T4 and TSH was calculated.

Conditions: Keratoconus, Corneal Ectasia, Thyroid Eye Disease
Being tested: Pentacam tomography
Keywords: keratoconus, pentacam, TED
Medical subject headings: Keratoconus, Graves Ophthalmopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pentacam tomographyDiagnostic test
The Pentacam maps were analyzed. The following anterior and posterior corneal surface parameters were evaluated by the Scheimpflug system: Kf, Ks, Kmax. The pachymetric map was analyzed, including CCT at the apex of the geometric center and CTmin. PPIavg, PPI min and PPI max were calculated . The Ambrósio relational thickness (ART) was calculated The posterior corneal elevation maps were evaluated and the posterior corneal elevation values relative to this reference were recorded. The back difference elevation and multimetric D index values were extrapolated from the difference map of the Belin/Ambrósio-enhanced ectasia display of the Pentacam system.

Study groups in NCT04433936
Study group	Role	What they receive
Thyroid Gland Dysfunction		Patients with a recent diagnosis of TGD (the study group) were recruited from endocrinology outpatient clinic of Specialized Medical Hospital, Mansoura University. Diagnosis of TGD was based on précised history, clinical examination and laboratory investigations. In order to avoid bias, patients with history of intake of any thyroid-related medications (antithyroid medications or thyroxine replacement), radioactive iodine or thyroidectomy were excluded from the study. Receives: Diagnostic Test: Pentacam tomography
Control		fifty age and gender matched healthy subjects without known personal or family history of thyroid disease or any autoimmune diseases were recruited from candidates of refractive surgery referred to the outpatient clinic of Mansoura Ophthalmology Center for pentacam assessment and who were proved to have normal corneal pentacam parameters. They were further examined by the endocrinologist to exclude thyroid dysfunction; this was supported by normal thyroid function profile (serum TSH and free T4) and negative anti-TPO and antithyroglobulin antibodies. Receives: Diagnostic Test: Pentacam tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

corneal tomographic parameter
analysis of pentacam maps
Measured: 1 day (once at first recruitment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 20181 Jun 2018

First posted16 Jun 2020
Study start1 Feb 2018
Primary completion1 Jun 2018
Study completion1 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (32)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: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04433936
Sponsor's protocol ID: Pentacam parameters in TGD
Status last verified: Jun 2020
First submitted: 13 Jun 2020
Last updated: 16 Jun 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Rabinowitz YS. Keratoconus. Surv Ophthalmol. 1998 Jan-Feb;42(4):297-319. doi: 10.1016/s0039-6257(97)00119-7.
PubMed 9493273
Davidson AE, Hayes S, Hardcastle AJ, Tuft SJ. The pathogenesis of keratoconus. Eye (Lond). 2014 Feb;28(2):189-95. doi: 10.1038/eye.2013.278. Epub 2013 Dec 20.
PubMed 24357835
McMonnies CW. Inflammation and keratoconus. Optom Vis Sci. 2015 Feb;92(2):e35-41. doi: 10.1097/OPX.0000000000000455.
PubMed 25397925
Galvis V, Sherwin T, Tello A, Merayo J, Barrera R, Acera A. Keratoconus: an inflammatory disorder? Eye (Lond). 2015 Jul;29(7):843-59. doi: 10.1038/eye.2015.63. Epub 2015 May 1.
PubMed 25931166
Conrad AH, Zhang Y, Walker AR, Olberding LA, Hanzlick A, Zimmer AJ, Morffi R, Conrad GW. Thyroxine affects expression of KSPG-related genes, the carbonic anhydrase II gene, and KS sulfation in the embryonic chicken cornea. Invest Ophthalmol Vis Sci. 2006 Jan;47(1):120-32. doi: 10.1167/iovs.05-0806.
PubMed 16384953
COULOMBRE AJ, COULOMBRE JL. CORNEAL DEVELOPMENT. 3. THE ROLE OF THE THYROID IN DEHYDRATION AND THE DEVELOPMENT OF TRANSPARENCY. Exp Eye Res. 1964 Jun;3:105-14. doi: 10.1016/s0014-4835(64)80024-5. No abstract available.
PubMed 14211912
Robson H, Siebler T, Stevens DA, Shalet SM, Williams GR. Thyroid hormone acts directly on growth plate chondrocytes to promote hypertrophic differentiation and inhibit clonal expansion and cell proliferation. Endocrinology. 2000 Oct;141(10):3887-97. doi: 10.1210/endo.141.10.7733.
PubMed 11014246
Kocak Altintas AG, Gul U, Duman S. Bilateral keratoconus associated with Hashimoto's disease, alopecia areata and atopic keratoconjunctivitis. Eur J Ophthalmol. 1999 Apr-Jun;9(2):130-3. doi: 10.1177/112067219900900210.
PubMed 10435426
Thanos S, Oellers P, Meyer Zu Horste M, Prokosch V, Schlatt S, Seitz B, Gatzioufas Z. Role of Thyroxine in the Development of Keratoconus. Cornea. 2016 Oct;35(10):1338-46. doi: 10.1097/ICO.0000000000000988.
PubMed 27560028
Flasko Z, Zemova E, Eppig T, Modis L, Langenbucher A, Wagenpfeil S, Seitz B, Szentmary N. Hypothyroidism is Not Associated with Keratoconus Disease: Analysis of 626 Subjects. J Ophthalmol. 2019 Oct 31;2019:3268595. doi: 10.1155/2019/3268595. eCollection 2019.
PubMed 31815013
El-Massry A, Doheim MF, Iqbal M, Fawzy O, Said OM, Yousif MO, Badawi AE, Tawfik A, Abousamra A. Association Between Keratoconus and Thyroid Gland Dysfunction: A Cross-Sectional Case-Control Study. J Refract Surg. 2020 Apr 1;36(4):253-257. doi: 10.3928/1081597X-20200226-03.
PubMed 32267956
Alhawari HH, Khader YS, Alhawari HH, Alomari AF, Abbasi HN, El-Faouri MS, Al Bdour MD. Autoimmune Thyroid Disease and Keratoconus: Is There an Association? Int J Endocrinol. 2018 Jul 31;2018:7907512. doi: 10.1155/2018/7907512. eCollection 2018.
PubMed 30154844
Karabulut GO, Kaynak P, Altan C, Ozturker C, Aksoy EF, Demirok A, Yilmaz OF. Corneal biomechanical properties in thyroid eye disease. Kaohsiung J Med Sci. 2014 Jun;30(6):299-304. doi: 10.1016/j.kjms.2014.02.015. Epub 2014 Apr 17.
PubMed 24835350
Moghimi S, Safizadeh M, Mazloumi M, Hosseini H, Vahedian Z, Rajabi MT. Evaluation of Corneal Biomechanical Properties in Patients With Thyroid Eye Disease Using Ocular Response Analyzer. J Glaucoma. 2016 Mar;25(3):269-73. doi: 10.1097/IJG.0000000000000254.
PubMed 26020688
Kirgiz A, Cabuk KS, Yetmis M, Atalay K. Corneal biomechanical properties in patients with Hashimoto's thyroiditis. Adv Clin Exp Med. 2019 Jan;28(1):109-112. doi: 10.17219/acem/85039.
PubMed 30311752

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Keratoconus trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Corneal Tomographic Analysis Among Patients With Thyroid Gland Dysfunction.
ClinicalTrials.gov ID: NCT04433936
Acronym / sponsor ID: Pentacam parameters in TGD
Conditions: Keratoconus, Corneal Ectasia, Thyroid Eye Disease
Keywords: keratoconus, pentacam, TED
Study type: Observational
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Ameera Gamal AbdelhameedUniversity, hospital or other
Study start: 1 Feb 2018 (actual)
Primary completion: 1 Jun 2018 (actual)
Study completion: 1 Jun 2018 (actual)
First posted: 16 Jun 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.

Detailed description

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Thyroid Gland Dysfunction	–	Diagnostic Test: Pentacam tomographyPatients with a recent diagnosis of TGD (the study group) were recruited from endocrinology outpatient clinic of Specialized Medical Hospital, Mansoura University. Diagnosis of TGD was based on précised history, clinical examination and laboratory investigations. In order to avoid bias, patients with history of intake of any thyroid-related medications (antithyroid medications or thyroxine replacement), radioactive iodine or thyroidectomy were excluded from the study.
Control	–	Diagnostic Test: Pentacam tomographyfifty age and gender matched healthy subjects without known personal or family history of thyroid disease or any autoimmune diseases were recruited from candidates of refractive surgery referred to the outpatient clinic of Mansoura Ophthalmology Center for pentacam assessment and who were proved to have normal corneal pentacam parameters. They were further examined by the endocrinologist to exclude thyroid dysfunction; this was supported by normal thyroid function profile (serum TSH and free T4) and negative anti-TPO and antithyroglobulin antibodies.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: 100 eyes of 50 patients with TGD (hypo-hyperthyroidism) and 100 eyes of 50 age and sex matched healthy controls.

Key inclusion criteria (1 listed)

For TGD patients: Patients with a recent diagnosis of TGD (the study group) were recruited from endocrinology outpatient clinic of Specialized Medical Hospital, Mansoura University. Diagnosis of TGD was based on précised history, clinical examination and laboratory investigations. In order to avoid bias, patients with history of intake of any thyroid-related medications (antithyroid medications or thyroxine replacement), radioactive iodine or thyroidectomy were excluded from the study. Therefore, we only included patients who did not received treatment yet For the control group, fifty age and gender matched healthy subjects without known personal or family history of thyroid disease or any autoimmune diseases were recruited from candidates of refractive surgery referred to the outpatient clinic of Mansoura Ophthalmology Center for pentacam assessment and who were proved to have normal corneal pentacam parameters. They were further examined by the endocrinologist to exclude thyroid dysfunction; this was supported by normal thyroid function profile (serum TSH and free T4) and negative anti-TPO and antithyroglobulin antibodies.

Key exclusion criteria (1 listed)

patients with previous thyroid medications or replacement therapy, thyroidectomy or radioactive iodine intake participants with a history of ocular surgery or trauma, use of any topical medication or contact lens wear, patients with any corneal pathology, Corneal dystrophy, corneal scarring or any concurrent ocular disease. To eliminate other risk factors for KC, we also excluded participants with a history of persistent eye rubbing, vernal keratoconjunctivitis (VKC), atopy, Down syndrome, Turner's syndrome, or congenital rubella. Pregnant or lactating females were also excluded from the study.

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
Pentacam tomographyThe Pentacam maps were analyzed. The following anterior and posterior corneal surface parameters were evaluated by the Scheimpflug system: Kf, Ks, Kmax. The pachymetric map was analyzed, including CCT at the apex of the geometric center and CTmin. PPIavg, PPI min and PPI max were calculated . The Ambrósio relational thickness (ART) was calculated The posterior corneal elevation maps were evaluated and the posterior corneal elevation values relative to this reference were recorded. The back difference elevation and multimetric D index values were extrapolated from the difference map of the Belin/Ambrósio-enhanced ectasia display of the Pentacam system.	Diagnostic test	Control, Thyroid Gland Dysfunction

Primary outcome

corneal tomographic parameter
Time frame: 1 day (once at first recruitment)
analysis of pentacam maps

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 16 Jun 2020.
Background: PubMed 9493273Rabinowitz YS. Keratoconus. Surv Ophthalmol. 1998 Jan-Feb;42(4):297-319. doi: 10.1016/s0039-6257(97)00119-7.
Background: PubMed 24357835Davidson AE, Hayes S, Hardcastle AJ, Tuft SJ. The pathogenesis of keratoconus. Eye (Lond). 2014 Feb;28(2):189-95. doi: 10.1038/eye.2013.278. Epub 2013 Dec 20.
Background: PubMed 25397925McMonnies CW. Inflammation and keratoconus. Optom Vis Sci. 2015 Feb;92(2):e35-41. doi: 10.1097/OPX.0000000000000455.
Background: PubMed 25931166Galvis V, Sherwin T, Tello A, Merayo J, Barrera R, Acera A. Keratoconus: an inflammatory disorder? Eye (Lond). 2015 Jul;29(7):843-59. doi: 10.1038/eye.2015.63. Epub 2015 May 1.
Background: PubMed 16384953Conrad AH, Zhang Y, Walker AR, Olberding LA, Hanzlick A, Zimmer AJ, Morffi R, Conrad GW. Thyroxine affects expression of KSPG-related genes, the carbonic anhydrase II gene, and KS sulfation in the embryonic chicken cornea. Invest Ophthalmol Vis Sci. 2006 Jan;47(1):120-32. doi: 10.1167/iovs.05-0806.
Background: PubMed 14211912COULOMBRE AJ, COULOMBRE JL. CORNEAL DEVELOPMENT. 3. THE ROLE OF THE THYROID IN DEHYDRATION AND THE DEVELOPMENT OF TRANSPARENCY. Exp Eye Res. 1964 Jun;3:105-14. doi: 10.1016/s0014-4835(64)80024-5. No abstract available.
Background: PubMed 11014246Robson H, Siebler T, Stevens DA, Shalet SM, Williams GR. Thyroid hormone acts directly on growth plate chondrocytes to promote hypertrophic differentiation and inhibit clonal expansion and cell proliferation. Endocrinology. 2000 Oct;141(10):3887-97. doi: 10.1210/endo.141.10.7733.
Background: PubMed 10435426Kocak Altintas AG, Gul U, Duman S. Bilateral keratoconus associated with Hashimoto's disease, alopecia areata and atopic keratoconjunctivitis. Eur J Ophthalmol. 1999 Apr-Jun;9(2):130-3. doi: 10.1177/112067219900900210.
Background: PubMed 27560028Thanos S, Oellers P, Meyer Zu Horste M, Prokosch V, Schlatt S, Seitz B, Gatzioufas Z. Role of Thyroxine in the Development of Keratoconus. Cornea. 2016 Oct;35(10):1338-46. doi: 10.1097/ICO.0000000000000988.
Background: PubMed 31815013Flasko Z, Zemova E, Eppig T, Modis L, Langenbucher A, Wagenpfeil S, Seitz B, Szentmary N. Hypothyroidism is Not Associated with Keratoconus Disease: Analysis of 626 Subjects. J Ophthalmol. 2019 Oct 31;2019:3268595. doi: 10.1155/2019/3268595. eCollection 2019.
Background: PubMed 32267956El-Massry A, Doheim MF, Iqbal M, Fawzy O, Said OM, Yousif MO, Badawi AE, Tawfik A, Abousamra A. Association Between Keratoconus and Thyroid Gland Dysfunction: A Cross-Sectional Case-Control Study. J Refract Surg. 2020 Apr 1;36(4):253-257. doi: 10.3928/1081597X-20200226-03.
Background: PubMed 30154844Alhawari HH, Khader YS, Alhawari HH, Alomari AF, Abbasi HN, El-Faouri MS, Al Bdour MD. Autoimmune Thyroid Disease and Keratoconus: Is There an Association? Int J Endocrinol. 2018 Jul 31;2018:7907512. doi: 10.1155/2018/7907512. eCollection 2018.

Related trials for Keratoconus

Not yet recruiting
Performance Evaluation of the OCUTOP Hand-held Corneal Topographer
Corneal Topography, Dry Eye Syndromes
Recruiting
Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus
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RecruitingObservational study
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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.

Rania Bassiouny, MD principal investigator

Mansoura University

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 Keratoconus and Corneal Ectasia, run by Ameera Gamal Abdelhameed at 1 site in Egypt.

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 16 Jun 2020. 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 Egypt. 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?

corneal tomographic parameter (time frame: 1 day (once at first recruitment)). 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 NCT04433936, which also lists 32 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 16 Jun 2020.