Viewing Study NCT06163105



Ignite Creation Date: 2024-05-06 @ 7:52 PM
Last Modification Date: 2024-10-26 @ 3:15 PM
Study NCT ID: NCT06163105
Status: RECRUITING
Last Update Posted: 2023-12-18
First Post: 2023-11-30

Brief Title: The Effect of Gland Expression on the Regeneration of Meibomian Gland
Sponsor: Chulalongkorn University
Organization: Chulalongkorn University

Study Overview

Official Title: The Effect of Gland Expression on the Regeneration of Meibomian Gland
Status: RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The goal of this clinical trial is to compare the percentage of meibomian gland MG dropout in patients who are treated with additional meibomian gland expression MGX and in patients who are not The main questions it aims to answer are

Does additional MGX reverse MG dropout and support regeneration of MG
Does additional MGX have better effect on tear film stability MG function lid morphology tear cytokines than lid hygiene alone

Methods

Participants will be randomly assigned into MGX group as a treatment group and control group to assess study outcomes The basic treatment of the 2 groups included lid hygiene once daily and artificial tear The treatment duration lasts for 12 weeks Patients will be examined at baseline at 4-week 8-week 12-week visit for MG dropout percentage MG morphology lid margin abnormalities Meibum assessment tear film tear cytokines and pain score to see if additional MGX can regenerate MG better than lid hygiene alone
Detailed Description: 1 Study design an assessor-blinded randomized controlled trial
2 Target population MGD patients having mild to moderate MG dropout from Out-clinic at King Chulalongkorn Memorial Hospital KCMH

4 Randomization and blinding Permuted block randomization will be used After recruiting in this study participants who meet the eligibility criteria will be divided into 2 groups by research assistant There is an independent ophthalmologist AL who is blinded to treatment allocation

5Data collection Demographic characteristics numeric rating scale-11 NRS-11 and ocular surface disease index OSDI will be collected by interviewing Other parameters will be collected by slit lamp examination specific machines or further investigations All the data will be filled in the medical record The participants will be identified on medical record by a unique research number not by name or identification ID number apart from on the consent form and enrollment log Patients ID name surname and phone number will be stored in different file by the research assistant The data will be locked up and destroyed 5 years after the study ends

When the patients are recruited in the study the patients will be provided information sheet and explained about the study If the patients agree to participate in the study they will be asked to sign the consent form Then they will be appointed to return to the Refractive Surgery Center in the next day for examination and tear collection between 1 pm to 3 pm because some cytokines are independent diurnal rhythms

All outcome data will be collected by one single masked investigator AL The data will be collected at 4 time points day 0 week 4 week 8 and week 12 At baseline and 12-week post treatment participants are required to be at the hospital on time within the period of 1 pm to 3 pm for tear collection In each visit the examination must be done in correct order in order not to avoid the results of outcomes These steps include

Tear collection
Evaluating the ocular symptoms
Measuring lipid layer thickness
Slit-lamp examination tear break up time lid margin abnormality meibum expressibility and meibum quality
Non-contact infrared Meibography
Evaluating adverse events

8 Sample size There is no previous study showing the difference in Meibomian gland dropout area between these groups Our experts opinion about minimal clinical difference is 10 The standard deviation of meibomian gland dropout area in obstruction MGD patients is 167 We use the formula for a trial with an equal allocation ratio and repeated measurements This will be inflated for a 10 drop out giving a total sample size of 32 per group total sample size of 64
Statistical analysis

Stata version 17 software are utilized All statistical analyses were undertaken by a researcher who are blinded to group allocation The data were analyzed using an intention-to-treat ITT framework which included all participants randomized in the study regardless of the treatment type or exposure received Per protocol PP is added as a supportive analysis PP analysis will exclude the participants who do the lid hygiene less than 20 days per month or using any other treatment than advice A significance level of 5 was used in all statistical tests

Demographic data will be interpreted by descriptive analysis The primary outcome is the change in meibomian gland percentages of each eyelid from baseline over all follow-up visits analyzing by linear mixed models with random intercept for patient adjusting for baseline Meibomian gland percentage in the study participants and modelling time as a discrete variable Marginal models will be used to predict the discrete changes at each study month OSDI tear break up time and lipid layer thickness are analyzed by linear mixed models LMM Lid abnormalities meibum score and MG morphology will be analyzed by generalized linear mixed model GLMM Cytokine levels will be analyzed by unpaired t test

9 Missing data management If a patient chooses to withdraw from the study the reason for withdrawal will be documented These reasons will be valuable for analyzing the results later on Multiple imputation method will be used to handle with missing data

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None