Morphological Analysis of Meibomian Glands

NCT04052841 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2023-04-25

No results posted yet for this study

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

Interventions

PROCEDURE

Thermal pulsation

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.

PROCEDURE

Intense pulsed light therapy

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.

PROCEDURE

Manual warm compresses

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).

Sponsors & Collaborators

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Jin Yuan, PHD · Zhongshan Ophthalmic Center, Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-12
Primary Completion
2023-07-01
Completion
2023-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04052841 on ClinicalTrials.gov