NCT06218992

Brief Summary

Diabetes mellitus has been associated with ocular surface damage and exacerbates dry eye disease (DED) pathology. To investigate clinical and inflammatory changes in the ocular surface of insulin-independent type II diabetic patients. This cross-sectional control study will recruit 200 Type 2 diabetic patients and 200 age- and sex-matched subjects without DM.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 30, 2023

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 23, 2024

Status Verified

November 1, 2023

Enrollment Period

5 months

First QC Date

January 10, 2024

Last Update Submit

January 22, 2024

Conditions

Dry Eye DiseaseTear FilmCorneal Nerve

Keywords

dry eyetear film

Outcome Measures

Primary Outcomes (1)

  • MMP-9

    MMP-9 was measured using an immunochromatography assay by collecting 1ul tear samples from the lateral canthus using a capillary tear collector. To assess the concentration of MMP-9 in the tear samples, a commercial reagent card (S05B, Seinda Biomedical Corporation, Guangdong, China) based on colloidal gold and immunochromatographic analysis was utilized. 1ul tear sample was placed in the sampling hole on the reagent card, followed by three drops of diluent in the dilution hole. The reagent card was loaded into the proprietary analyzer, and 15 minutes later, the MMP-9 concentration was measured

    Baseline

Secondary Outcomes (13)

  • Non-invasive tear break-up time

    Baseline

  • Conjunctival hyperemia (RS score)

    Baseline

  • Quality of meibum grade

    Baseline

  • Expressibility of meibum grade

    Baseline

  • Conjunctivocorneal epithelial staining grade

    Baseline

  • +8 more secondary outcomes

Study Arms (2)

Study group

Type 2 diabetic patients

Control group

Age- and sex-matched subjects without DM

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants will be recruited at the Department of Ophthalmology, HESH.

You may qualify if:

  • Participants are diagnosed with dry eye according to the TFOS DEWS II diagnostic criteria: (a) OSDI questionnaire ≥13, (b) Non-invasive tear breakup time (NITBUT) \<10 s, (c) ocular surface staining \>5 corneal spots, greater than nine conjunctival spots (The presence of two or more criteria was used to establish a positive DE diagnosis).
  • Age ≥ 18

You may not qualify if:

  • Active ocular infection, such as infectious, viral, chlamydial, or immunologic conjunctivitis
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

He Eye Hospital

Shenyang, Liaoning, 110034, China

RECRUITING

Related Publications (13)

  • 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.

    PMID: 32175717BACKGROUND

  • 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.

    PMID: 25897358BACKGROUND

  • 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.

    PMID: 36589805BACKGROUND

  • 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.

    PMID: 27119078BACKGROUND

  • 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.

    PMID: 35508213BACKGROUND

  • 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.

    PMID: 1506758BACKGROUND

  • 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.

    PMID: 19274419BACKGROUND

  • 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.

    PMID: 28513494BACKGROUND

  • 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.

    PMID: 35495002BACKGROUND

  • 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.

    PMID: 28736340BACKGROUND

  • 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.

    PMID: 36830827BACKGROUND

  • 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.

    PMID: 37751961BACKGROUND

  • 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.

    PMID: 36361378BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Guanghao Qin

    He Eye Hospital

    STUDY CHAIR

Central Study Contacts

Guanghao Qin

CONTACT

+8618842664420qinguanghao@hsyk.com.cn

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2024

First Posted

January 23, 2024

Study Start

December 30, 2023

Primary Completion

May 31, 2024

Study Completion

December 31, 2024

Last Updated

January 23, 2024

Record last verified: 2023-11

Locations

CN(1)