- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04433936
Corneal Tomographic Parameters in TGD
June 15, 2020 updated by: Ameera Gamal Abdelhameed
Corneal Tomographic Analysis Among Patients With Thyroid Gland Dysfunction.
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 and to highlight whether early screening of those patients would be necessary for early detection of KC.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Dakahlia
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Mansoura, Dakahlia, Egypt
- Mansoura University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
100 eyes of 50 patients with TGD (hypo-hyperthyroidism) and 100 eyes of 50 age and sex matched healthy controls.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
corneal tomographic parameter
Time Frame: 1 day (once at first recruitment)
|
analysis of pentacam maps
|
1 day (once at first recruitment)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rania Bassiouny, MD, Mansoura University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Rabinowitz YS. Keratoconus. Surv Ophthalmol. 1998 Jan-Feb;42(4):297-319. doi: 10.1016/s0039-6257(97)00119-7.
- 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.
- McMonnies CW. Inflammation and keratoconus. Optom Vis Sci. 2015 Feb;92(2):e35-41. doi: 10.1097/OPX.0000000000000455.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Gatzioufas Z, Panos GD, Brugnolli E, Hafezi F. Corneal topographical and biomechanical variations associated with hypothyroidism. J Refract Surg. 2014 Feb;30(2):78-9. doi: 10.3928/1081597X-20140120-01. No abstract available.
- UTIGER RD. RADIOIMMUNOASSAY OF HUMAN PLASMA THYROTROPIN. J Clin Invest. 1965 Aug;44(8):1277-86. doi: 10.1172/JCI105234. No abstract available.
- Ross DS, Burch HB, Cooper DS, Greenlee MC, Laurberg P, Maia AL, Rivkees SA, Samuels M, Sosa JA, Stan MN, Walter MA. 2016 American Thyroid Association Guidelines for Diagnosis and Management of Hyperthyroidism and Other Causes of Thyrotoxicosis. Thyroid. 2016 Oct;26(10):1343-1421. doi: 10.1089/thy.2016.0229. Erratum In: Thyroid. 2017 Nov;27(11):1462.
- Chaudhary V, Bano S. Thyroid ultrasound. Indian J Endocrinol Metab. 2013 Mar;17(2):219-27. doi: 10.4103/2230-8210.109667.
- Ambrosio 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.
- O'Brart DP, Patel P, Lascaratos G, Wagh VK, Tam C, Lee J, O'Brart NA. Corneal Cross-linking to Halt the Progression of Keratoconus and Corneal Ectasia: Seven-Year Follow-up. Am J Ophthalmol. 2015 Dec;160(6):1154-63. doi: 10.1016/j.ajo.2015.08.023. Epub 2015 Aug 22.
- Bahceci UA, Ozdek S, Pehlivanli Z, Yetkin I, Onol M. Changes in intraocular pressure and corneal and retinal nerve fiber layer thicknesses in hypothyroidism. Eur J Ophthalmol. 2005 Sep - Oct 2005;15(5):556-561. doi: 10.5301/EJO.2008.1004.
- Gatzioufas Z, Thanos S. Acute keratoconus induced by hypothyroxinemia during pregnancy. J Endocrinol Invest. 2008 Mar;31(3):262-6. doi: 10.1007/BF03345600.
- Hoogewoud F, Gatzioufas Z, Hafezi F. Transitory topographical variations in keratoconus during pregnancy. J Refract Surg. 2013 Feb;29(2):144-6. doi: 10.3928/1081597X-20130117-11.
- Hafezi F, Iseli HP. Pregnancy-related exacerbation of iatrogenic keratectasia despite corneal collagen crosslinking. J Cataract Refract Surg. 2008 Jul;34(7):1219-21. doi: 10.1016/j.jcrs.2008.02.036.
- Lang GE, Naumann GO. [Keratoconus in Alagille syndrome]. Klin Monbl Augenheilkd. 1991 Jun;198(6):555-7. doi: 10.1055/s-2008-1046031. German.
- 27. King EF. Keratoconus following thyroidectomy. Transactions of the Ophthalmological Societies of the United Kingdom. 1953; 73: 31-39.
- Lee R, Hafezi F, Randleman JB. Bilateral Keratoconus Induced by Secondary Hypothyroidism After Radioactive Iodine Therapy. J Refract Surg. 2018 May 1;34(5):351-353. doi: 10.3928/1081597X-20171031-02.
- Ucakhan OO, Cetinkor V, Ozkan M, Kanpolat A. Evaluation of Scheimpflug imaging parameters in subclinical keratoconus, keratoconus, and normal eyes. J Cataract Refract Surg. 2011 Jun;37(6):1116-24. doi: 10.1016/j.jcrs.2010.12.049.
- 30. Baker KC, Chen YL, Shi L, Lewis JWL, Kugler L, Wang M. Does the Posterior Corneal Elevation Provide the First Indication of Keratoconus? Invest. Ophthalmol. Vis. Sci. 2010; 51(13):4963.
- Nemet AY, Vinker S, Bahar I, Kaiserman I. The association of keratoconus with immune disorders. Cornea. 2010 Nov;29(11):1261-4. doi: 10.1097/ICO.0b013e3181cb410b.
- AlHawari HH and Al Bdour MD. Vernal keratoconjunctivitis and severe keratoconus associated with autoimmune polyglandular syndrome type II (APS-2): a case report," Jordan Medical Journal 2016; 50(3): 157-159.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 1, 2018
Primary Completion (ACTUAL)
June 1, 2018
Study Completion (ACTUAL)
June 1, 2018
Study Registration Dates
First Submitted
June 13, 2020
First Submitted That Met QC Criteria
June 15, 2020
First Posted (ACTUAL)
June 16, 2020
Study Record Updates
Last Update Posted (ACTUAL)
June 16, 2020
Last Update Submitted That Met QC Criteria
June 15, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pentacam parameters in TGD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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