Morphological Analysis of Meibomian Glands

NCT04052841 | Unknown

• 1 other identifier: 20190722
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief Summary

An automated quantitative meibomian gland analyzer based on all kinds of infrared meibomian gland images was develop to obtain more detail in meibomian gland, including width, length, area, signal intensity correlated to the quality of meibum, deformation index and ratio of area of each visible specific gland. The purpose of this study is present as separate sections the following points: (1) to compared the detailed characteristics of meibomian glands in normal subjects, Meibomian gland dysfunction (MGD) patients by the automated quantitative analyzer; (2) to identify the inter-examiner and intra-examiner repeatability of the new technique; (3) to explore the correlation among morphological and functional parameters of meibomian gland and risk factors，clinical symptoms and signs; (4) to explore the sensitivity and specificity of meibomian gland morphological and functional parameters in MGD diagnosis. (5) using morphological and functional parameters as new assessment of MGD severity and efficacy indicators for treatment.

Conditions

Meibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (2)

• Mophology of meibomian glands

  Infrared photography of inversed upper meibomian glands were measured by Meibography pattern of Keratograph 5M (Oculus, Wetzlar, Germany). The infrared images of Meibography were analysed using the new developed software for identifying the mophology features of meibomian glands in millimeter.

  30 days after commencement of treatment

• Functional feature of meibomian glands

  Infrared photography of inversed upper and lower meibomian glands were measured by Meibography pattern of Keratograph 5M (Oculus, Wetzlar, Germany). The infrared images of Meibography were analysed using the new developed software for identifying the mean signal intensity of meibomian glands in millimeter.

  30 days after commencement of treatment

Secondary Outcomes (48)

• Non-invasive tear-film break-up time

  Baseline

• Non-invasive tear-film break-up time

  15 days after commencement of treatment

• Non-invasive tear-film break-up time

  30 days after commencement of treatment

• Non-invasive tear-film break-up time

  90 days after commencement of treatment

• Non-invasive tear-film break-up time

  180 days after commencement of treatment

Study Arms (4)

MGD-thermal pulsation group

EXPERIMENTAL

A 12 minutes LIPIFLOW treatment was performed.

Procedure: Thermal pulsation

MGD-IPL group

EXPERIMENTAL

IPL was performed every 3 weeks，3 times in total (0, 3w, 6w).

Procedure: Intense pulsed light therapy

MGD-manual warm compresses

EXPERIMENTAL

Manual warm compresses were performed every 2 weeks，5 times in total (0, 2w, 4w, 6w, 8w).

Procedure: Manual warm compresses

Normal health subject group

NO INTERVENTION

Normal health subject without intervention.

Interventions

Thermal pulsation PROCEDURE

Participants underwent a single LipiFlow® thermal pulsation system (TearScience Inc., Morrisville, NC,USA) treatment on the first visit: after lid hygiene with wet cotton swabs(OCuSOFT, Inc., Texas, USA) and instillation of anesthetic eye drops (Alcaine, proparacaine hydrochloride 0.4 ml/2mg) in both eyes, sterile eye cups were placed on to the conjunctival sac as instructed by the manufacturer, after 12 minutes of upper and lower palpebral conjunctival surfaces heat while simultaneously graded pulsatile pressure applying, eye cups were removed slightly.

MGD-thermal pulsation group

Intense pulsed light therapy PROCEDURE

Lid hygiene with wet cotton swabs(OCuSOFT, Inc., Texas, USA) before treatment. Intense pulsed light (IPL) with a range of wavelength (570 or 620 nm) was performed every 3 weeks，3 times in total (0, 3w, 6w). 10 pulses were transmited from one tragus through nose to the other tragus was a single pass, each treatment needed to do 2 passes. Manual lid massage was done after per IPL treatment.

MGD-IPL group

Manual warm compresses PROCEDURE

Lids hygiene of both eyes with wet cotton swabs(OCuSOFT, Inc., Texas, USA).Commercial heated eye patch was use for 10 min. Manual lid massage every 2 weeks, 5 times in total(0，2w, 4w, 4w, 8w).

MGD-manual warm compresses

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 70 years.
• Patients and healthy volunteers who are willing and capable to participate in this clinical study with signed Informed Consent Form.
• Clinical diagnosis of MGD: The diagnosis of MGD was based on an altered quality of expressed secretions and/or decreased or absent expression.
• Patients without ≥2/3 Meibomian glands atrophy.
• Fitzpatrick skin type 1-4.
• Negative history or condition of ocular or systemic illness based on evaluation by a research physician.

You may not qualify if:

• Patients and healthy volunteers with ocular allergies, trauma, contact lens wear, continuous medications usage such as tretinoin, isotretinoin, antidepressant medications, photosensitive drugs, glucocorticoids and immunomodulators, or have used them within one month.
• Patients and healthy volunteers who have a history of ocular surface surgery.
• Patients and healthy volunteers who have active ocular surface infection or have suffered from ocular surface infection within one month.
• Patients and healthy volunteers who have endophthalmitis or a medical history of endophthalmitis.
• Patients and healthy volunteers who have a medical history of viral keratitis infection.
• Women who are pregnant, planning to become pregnant during the course of the study or breast-feeding (women of child-bearing age will be asked by the physician).
• Meibography images were blurred or with obvious tarsus folds, incomplete exposure and large hyperreflective area.
• Patients and healthy volunteers who are not suitable for the trial as determined by investigators.
• Patients have abnormalities of ocular surface function or eyelid function, or presence of precancerous lesions, cancer or pigmentation in the eyelid area.
• Patients who have plans to receive ocular surgeries (e.g., cataract, myopic refractive surgery) within 6 months.
• Patients who have been treated with lacrimal punctum embolization within one month.
• Patients with disease that could lead to ADDE, such as Sjogren syndrome and a lacrimal gland abnormality.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (2)

Zhongshan Ophthalmic Center, Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Deng Yuqing

Guangzhou, 510060, China

RECRUITING

Related Publications (14)

• Arita R, Suehiro J, Haraguchi T, Shirakawa R, Tokoro H, Amano S. Objective image analysis of the meibomian gland area. Br J Ophthalmol. 2014 Jun;98(6):746-55. doi: 10.1136/bjophthalmol-2012-303014. Epub 2013 Jun 27.

  PMID: 23813417 RESULT

• Nelson JD, Shimazaki J, Benitez-del-Castillo JM, Craig JP, McCulley JP, Den S, Foulks GN. The international workshop on meibomian gland dysfunction: report of the definition and classification subcommittee. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):1930-7. doi: 10.1167/iovs.10-6997b. Print 2011 Mar. No abstract available.

  PMID: 21450914 RESULT

• Schein OD, Munoz B, Tielsch JM, Bandeen-Roche K, West S. Prevalence of dry eye among the elderly. Am J Ophthalmol. 1997 Dec;124(6):723-8. doi: 10.1016/s0002-9394(14)71688-5.

  PMID: 9402817 RESULT

• Lekhanont K, Rojanaporn D, Chuck RS, Vongthongsri A. Prevalence of dry eye in Bangkok, Thailand. Cornea. 2006 Dec;25(10):1162-7. doi: 10.1097/01.ico.0000244875.92879.1a.

  PMID: 17172891 RESULT

• Uchino M, Dogru M, Yagi Y, Goto E, Tomita M, Kon T, Saiki M, Matsumoto Y, Uchino Y, Yokoi N, Kinoshita S, Tsubota K. The features of dry eye disease in a Japanese elderly population. Optom Vis Sci. 2006 Nov;83(11):797-802. doi: 10.1097/01.opx.0000232814.39651.fa.

  PMID: 17106406 RESULT

• Chia EM, Mitchell P, Rochtchina E, Lee AJ, Maroun R, Wang JJ. Prevalence and associations of dry eye syndrome in an older population: the Blue Mountains Eye Study. Clin Exp Ophthalmol. 2003 Jun;31(3):229-32. doi: 10.1046/j.1442-9071.2003.00634.x.

  PMID: 12786773 RESULT

• Schaumberg DA, Sullivan DA, Buring JE, Dana MR. Prevalence of dry eye syndrome among US women. Am J Ophthalmol. 2003 Aug;136(2):318-26. doi: 10.1016/s0002-9394(03)00218-6.

  PMID: 12888056 RESULT

• Wise RJ, Sobel RK, Allen RC. Meibography: A review of techniques and technologies. Saudi J Ophthalmol. 2012 Oct;26(4):349-56. doi: 10.1016/j.sjopt.2012.08.007.

  PMID: 23961019 RESULT

• Tomlinson A, Bron AJ, Korb DR, Amano S, Paugh JR, Pearce EI, Yee R, Yokoi N, Arita R, Dogru M. The international workshop on meibomian gland dysfunction: report of the diagnosis subcommittee. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2006-49. doi: 10.1167/iovs.10-6997f. Print 2011 Mar. No abstract available.

  PMID: 21450918 RESULT

• Simcock B. The role of the intrauterine device in contraceptive practice. Aust Fam Physician. 1976 Mar;5(2):124-39.

  PMID: 942338 RESULT

• Knop E, Knop N, Brewitt H, Pleyer U, Rieck P, Seitz B, Schirra F. [Meibomian glands : part III. Dysfunction - argument for a discrete disease entity and as an important cause of dry eye]. Ophthalmologe. 2009 Nov;106(11):966-79. doi: 10.1007/s00347-009-2043-9. German.

  PMID: 19941140 RESULT

• Arita R, Itoh K, Maeda S, Maeda K, Furuta A, Fukuoka S, Tomidokoro A, Amano S. Proposed diagnostic criteria for obstructive meibomian gland dysfunction. Ophthalmology. 2009 Nov;116(11):2058-63.e1. doi: 10.1016/j.ophtha.2009.04.037. Epub 2009 Sep 10.

  PMID: 19744718 RESULT

• Koh YW, Celik T, Lee HK, Petznick A, Tong L. Detection of meibomian glands and classification of meibography images. J Biomed Opt. 2012 Aug;17(8):086008. doi: 10.1117/1.JBO.17.8.086008.

  PMID: 23224195 RESULT

• Knop E, Knop N, Millar T, Obata H, Sullivan DA. The international workshop on meibomian gland dysfunction: report of the subcommittee on anatomy, physiology, and pathophysiology of the meibomian gland. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):1938-78. doi: 10.1167/iovs.10-6997c. Print 2011 Mar. No abstract available.

  PMID: 21450915 RESULT

MeSH Terms

Conditions

Meibomian Gland Dysfunction

Interventions

Intense Pulsed Light Therapy

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Study Officials

• Jin Yuan, PHD

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuqing Deng, MD

CONTACT

18120557291; 15927646647@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The recruitment of subjects must meet the diagnosis criteria of MGD the international workshop on meibomian gland dysfunction.

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: August 12, 2019
• Study Start: October 12, 2020
• Primary Completion: July 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (2)