Corneal and Tear Film Changes in Chinese Patients With Type 2 Diabetes
NCT ID: NCT06218992
Last Updated: 2024-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
80 participants
OBSERVATIONAL
2023-12-30
2024-12-31
Brief Summary
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Detailed Description
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A loss of tear film homeostasis characterizes DED. DM is one of the risk factors for DED; 47% of DM patients suffer from ocular surface damage due to negative alterations to the tear film, corneal thickness, corneal epithelium, corneal nerve, and corneal endothelium. It has been suggested that one or more of the following initial events may lead to alterations described in the tear film and ocular surface of patients with DM: a) chronic hyperglycemia, b) corneal nerve damage, and c) impairment on insulin action.
Previous studies have explored the association between DM and ocular surface dysfunction. However, ocular surface and tear film parameters in diabetic patients are lacking in the Chinese population. Moreover, corneal nerve damage and ocular surface inflammation have not been systematically evaluated. Our study aimed to investigate clinical and inflammatory changes in the ocular surface of insulin-independent type II diabetic patients in a Chinese population.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Study group
Type 2 diabetic patients
No interventions assigned to this group
Control group
Age- and sex-matched subjects without DM
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18
Exclusion Criteria
* A history of ocular surgery that might affect the corneal or tear film, such as corneal refractive surgery, keratoplasty, cataract surgery, or ocular laser surgery
* Long-term contact lens wear
* Other ocular diseases being treated might affect the corneal or tear film: such as glaucoma, dacryocystitis, uveitis, and pterygium.
18 Years
90 Years
ALL
No
Sponsors
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He Eye Hospital
OTHER
Responsible Party
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Principal Investigators
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Guanghao Qin
Role: STUDY_CHAIR
He Eye Hospital
Locations
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He Eye Hospital
Shenyang, Liaoning, China
Countries
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Central Contacts
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Facility Contacts
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References
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Khan MAB, Hashim MJ, King JK, Govender RD, Mustafa H, Al Kaabi J. Epidemiology of Type 2 Diabetes - Global Burden of Disease and Forecasted Trends. J Epidemiol Glob Health. 2020 Mar;10(1):107-111. doi: 10.2991/jegh.k.191028.001.
Nentwich MM, Ulbig MW. Diabetic retinopathy - ocular complications of diabetes mellitus. World J Diabetes. 2015 Apr 15;6(3):489-99. doi: 10.4239/wjd.v6.i3.489.
Zhou Q, Yang L, Wang Q, Li Y, Wei C, Xie L. Mechanistic investigations of diabetic ocular surface diseases. Front Endocrinol (Lausanne). 2022 Dec 16;13:1079541. doi: 10.3389/fendo.2022.1079541. eCollection 2022.
Vieira-Potter VJ, Karamichos D, Lee DJ. Ocular Complications of Diabetes and Therapeutic Approaches. Biomed Res Int. 2016;2016:3801570. doi: 10.1155/2016/3801570. Epub 2016 Mar 28.
Bu Y, Shih KC, Tong L. The ocular surface and diabetes, the other 21st Century epidemic. Exp Eye Res. 2022 Jul;220:109099. doi: 10.1016/j.exer.2022.109099. Epub 2022 May 1.
Sima AA. Review: pathogenesis, progression, and therapeutic intervention of diabetic neuropathy. J Ocul Pharmacol. 1992 Summer;8(2):173-81. doi: 10.1089/jop.1992.8.173. No abstract available.
Alves Mde C, Carvalheira JB, Modulo CM, Rocha EM. Tear film and ocular surface changes in diabetes mellitus. Arq Bras Oftalmol. 2008 Nov-Dec;71(6 Suppl):96-103. doi: 10.1590/s0004-27492008000700018.
Kesarwani D, Rizvi SWA, Khan AA, Amitava AK, Vasenwala SM, Siddiqui Z. Tear film and ocular surface dysfunction in diabetes mellitus in an Indian population. Indian J Ophthalmol. 2017 Apr;65(4):301-304. doi: 10.4103/ijo.IJO_939_15.
Naik K, Magdum R, Ahuja A, Kaul S, S J, Mishra A, Patil M, Dhore DN, Alapati A. Ocular Surface Diseases in Patients With Diabetes. Cureus. 2022 Mar 22;14(3):e23401. doi: 10.7759/cureus.23401. eCollection 2022 Mar.
Bron AJ, de Paiva CS, Chauhan SK, Bonini S, Gabison EE, Jain S, Knop E, Markoulli M, Ogawa Y, Perez V, Uchino Y, Yokoi N, Zoukhri D, Sullivan DA. TFOS DEWS II pathophysiology report. Ocul Surf. 2017 Jul;15(3):438-510. doi: 10.1016/j.jtos.2017.05.011. Epub 2017 Jul 20.
Dammak A, Pastrana C, Martin-Gil A, Carpena-Torres C, Peral Cerda A, Simovart M, Alarma P, Huete-Toral F, Carracedo G. Oxidative Stress in the Anterior Ocular Diseases: Diagnostic and Treatment. Biomedicines. 2023 Jan 20;11(2):292. doi: 10.3390/biomedicines11020292.
Qin G, Chen J, Li L, Qi Y, Zhang Q, Wu Y, You Y, Yang L, Moore J, Xu L, He W, Yu S, Pazo EE, He X. Relationship between ocular surface pain and corneal nerve loss in dry eye diabetics: a cross-sectional study in Shenyang, China. BMJ Open. 2023 Sep 26;13(9):e076932. doi: 10.1136/bmjopen-2023-076932.
Bahabayi A, Yang N, Xu T, Xue Y, Ma L, Gu X, Wang Y, Jia K. Expression of Matrix Metalloproteinase-2,-7,-9 in Serum during Pregnancy in Patients with Pre-Eclampsia: A Prospective Study. Int J Environ Res Public Health. 2022 Nov 4;19(21):14500. doi: 10.3390/ijerph192114500.
Other Identifiers
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DM2023
Identifier Type: -
Identifier Source: org_study_id
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