<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04433936</url>
  </required_header>
  <id_info>
    <org_study_id>Pentacam parameters in TGD</org_study_id>
    <nct_id>NCT04433936</nct_id>
  </id_info>
  <brief_title>Corneal Tomographic Parameters in TGD</brief_title>
  <official_title>Corneal Tomographic Analysis Among Patients With Thyroid Gland Dysfunction.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ameera Gamal Abdelhameed</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current study involved analysis of the corneal tomographic parameters of patients with&#xD;
      thyroid gland dysfunction (hyperthyroidism or hypothyroidism), including those with an&#xD;
      autoimmune etiology, in comparison to healthy controls without TGD, using pentacam, in an&#xD;
      attempt to detect possible early corneal changes and to highlight whether early screening of&#xD;
      those patients would be necessary for early detection of KC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 100 eyes of 50 patients with TGD and 100 eyes of 50 healthy controls were&#xD;
      enrolled. Diagnosis of TGD was based on history, clinical examination and laboratory&#xD;
      investigations. Exclusion criteria included previous thyroid medications, thyroidectomy,&#xD;
      previous ocular surgery, corneal pathology and other risk factors of keratoconus (KC). All&#xD;
      eyes were examined by Pentacam, (Oculus Optikgerate GmbH, Wetzlar, Germany). Pentacam&#xD;
      parameters were compared between TGD patients and controls. Spearman's correlation&#xD;
      coefficient between different pentacam parameters and the level of free T4 and TSH was&#xD;
      calculated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Actual">June 1, 2018</completion_date>
  <primary_completion_date type="Actual">June 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>corneal tomographic parameter</measure>
    <time_frame>1 day (once at first recruitment)</time_frame>
    <description>analysis of pentacam maps</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Keratoconus</condition>
  <condition>Corneal Ectasia</condition>
  <condition>Thyroid Eye Disease</condition>
  <arm_group>
    <arm_group_label>Thyroid Gland Dysfunction</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Pentacam tomography</intervention_name>
    <description>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.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Thyroid Gland Dysfunction</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        100 eyes of 50 patients with TGD (hypo-hyperthyroidism) and 100 eyes of 50 age and sex&#xD;
        matched healthy controls.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  For TGD patients: Patients with a recent diagnosis of TGD (the study group) were&#xD;
             recruited from endocrinology outpatient clinic of Specialized Medical Hospital,&#xD;
             Mansoura University. Diagnosis of TGD was based on précised history, clinical&#xD;
             examination and laboratory investigations. In order to avoid bias, patients with&#xD;
             history of intake of any thyroid-related medications (antithyroid medications or&#xD;
             thyroxine replacement), radioactive iodine or thyroidectomy were excluded from the&#xD;
             study. Therefore, we only included patients who did not received treatment yet For the&#xD;
             control group, fifty age and gender matched healthy subjects without known personal or&#xD;
             family history of thyroid disease or any autoimmune diseases were recruited from&#xD;
             candidates of refractive surgery referred to the outpatient clinic of Mansoura&#xD;
             Ophthalmology Center for pentacam assessment and who were proved to have normal&#xD;
             corneal pentacam parameters. They were further examined by the endocrinologist to&#xD;
             exclude thyroid dysfunction; this was supported by normal thyroid function profile&#xD;
             (serum TSH and free T4) and negative anti-TPO and antithyroglobulin antibodies.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with previous thyroid medications or replacement therapy, thyroidectomy or&#xD;
             radioactive iodine intake participants with a history of ocular surgery or trauma, use&#xD;
             of any topical medication or contact lens wear, patients with any corneal pathology,&#xD;
             Corneal dystrophy, corneal scarring or any concurrent ocular disease. To eliminate&#xD;
             other risk factors for KC, we also excluded participants with a history of persistent&#xD;
             eye rubbing, vernal keratoconjunctivitis (VKC), atopy, Down syndrome, Turner's&#xD;
             syndrome, or congenital rubella. Pregnant or lactating females were also excluded from&#xD;
             the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rania Bassiouny, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mansoura University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mansoura University</name>
      <address>
        <city>Mansoura</city>
        <state>Dakahlia</state>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Rabinowitz YS. Keratoconus. Surv Ophthalmol. 1998 Jan-Feb;42(4):297-319. doi: 10.1016/s0039-6257(97)00119-7.</citation>
    <PMID>9493273</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24357835</PMID>
  </reference>
  <reference>
    <citation>McMonnies CW. Inflammation and keratoconus. Optom Vis Sci. 2015 Feb;92(2):e35-41. doi: 10.1097/OPX.0000000000000455.</citation>
    <PMID>25397925</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>25931166</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>16384953</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>14211912</PMID>
  </reference>
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    <citation>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.</citation>
    <PMID>11014246</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>10435426</PMID>
  </reference>
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    <citation>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.</citation>
    <PMID>27560028</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>31815013</PMID>
  </reference>
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    <PMID>32267956</PMID>
  </reference>
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    <citation>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.</citation>
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  </reference>
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    <citation>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.</citation>
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    <citation>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.</citation>
    <PMID>27521067</PMID>
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    <PMID>23776892</PMID>
  </reference>
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    <citation>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.</citation>
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  </reference>
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    <citation>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.</citation>
    <PMID>26307513</PMID>
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    <citation>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.</citation>
    <PMID>28221458</PMID>
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    <citation>Gatzioufas Z, Thanos S. Acute keratoconus induced by hypothyroxinemia during pregnancy. J Endocrinol Invest. 2008 Mar;31(3):262-6. doi: 10.1007/BF03345600.</citation>
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    <citation>Lang GE, Naumann GO. [Keratoconus in Alagille syndrome]. Klin Monbl Augenheilkd. 1991 Jun;198(6):555-7. doi: 10.1055/s-2008-1046031. German.</citation>
    <PMID>1895727</PMID>
  </reference>
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    <citation>27. King EF. Keratoconus following thyroidectomy. Transactions of the Ophthalmological Societies of the United Kingdom. 1953; 73: 31-39.</citation>
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    <citation>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.</citation>
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    <citation>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.</citation>
    <PMID>21596255</PMID>
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    <citation>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.</citation>
  </reference>
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    <citation>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.</citation>
    <PMID>20802320</PMID>
  </reference>
  <reference>
    <citation>AlHawari HH and Al Bdour MD. Vernal keratoconjunctivitis and severe keratoconus associated with autoimmune polyglandular syndrome type II (APS-2): a case report,&quot; Jordan Medical Journal 2016; 50(3): 157-159.</citation>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 13, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Ameera Gamal Abdelhameed</investigator_full_name>
    <investigator_title>Lecturer of Ophthalmology</investigator_title>
  </responsible_party>
  <keyword>keratoconus</keyword>
  <keyword>pentacam</keyword>
  <keyword>TED</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Eye Diseases</mesh_term>
    <mesh_term>Keratoconus</mesh_term>
    <mesh_term>Graves Ophthalmopathy</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04433936
org study id: Pentacam parameters in TGD
nct id: NCT04433936
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Case-Control
time perspective: Prospective
measure: corneal tomographic parameter
time frame: 1 day (once at first recruitment)
description: analysis of pentacam maps
arm group label: Thyroid Gland Dysfunction
description: 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.
arm group label: Control
description: 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.
intervention type: Diagnostic Test
intervention name: Pentacam tomography
description: 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.
arm group label: Control
arm group label: Thyroid Gland Dysfunction
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Rania Bassiouny, MD
role: Principal Investigator
affiliation: Mansoura University
facility: 
country: Egypt
citation: Rabinowitz YS. Keratoconus. Surv Ophthalmol. 1998 Jan-Feb;42(4):297-319. doi: 10.1016/s0039-6257(97)00119-7.
PMID: 9493273
citation: 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.
PMID: 24357835
citation: McMonnies CW. Inflammation and keratoconus. Optom Vis Sci. 2015 Feb;92(2):e35-41. doi: 10.1097/OPX.0000000000000455.
PMID: 25397925
citation: 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.
PMID: 25931166
citation: 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.
PMID: 16384953
citation: 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.
PMID: 14211912
citation: 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.
PMID: 11014246
citation: 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.
PMID: 10435426
citation: 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.
PMID: 27560028
citation: 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.
PMID: 31815013
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responsible party type: Sponsor-Investigator
investigator affiliation: Mansoura University
investigator full name: Ameera Gamal Abdelhameed
investigator title: Lecturer of Ophthalmology
mesh term: Eye Diseases
mesh term: Keratoconus
mesh term: Graves Ophthalmopathy