Meibomian Gland Dysfunction Clinical Trial
Official title:
The Effect of Gland Expression on the Regeneration of Meibomian Gland
NCT number | NCT06163105 |
Other study ID # | 0868/66 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2024 |
Est. completion date | February 2025 |
Verified date | December 2023 |
Source | Chulalongkorn University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 question[s] 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.
Status | Not yet recruiting |
Enrollment | 64 |
Est. completion date | February 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Diagnosis of obstructive MGD - Visible Meibomian gland dropout of upper and lower eyelid from grade 1 to grade 2 (Arita's meiboscale) - If both eyes meet above criteria, only right eye is chosen Exclusion Criteria: - Diagnosis with secondary MGD - Having any eyedrop other than eye lubricant within the last 3 months - Any kind of eyelid treatment related to MGD within the last 6 months - History of ocular trauma, ocular surface surgery or eyelid surgery - History of intraocular surgery less than 6 months - Eyelid botulinum toxin injection within the last 6 months - Ocular diseases other than dry eye - Pregnant or breast-feeding - Wearing contact lens - Using any hormones therapy, anti-inflammatory drugs, tetracycline and macrolides - Refuse to participate in the study |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Chulalongkorn University | King Chulalongkorn Memorial Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Meibomian gland dropout percentage | The dropout percentage of upper and lower eyelid is calculated by (Area of Meibomian gland dropout) / (Area of tarsal plate)*100%. Non-contact infrared Meibography is carried out using Oculus Keratograph 5M with upper and lower eyelids everted consecutively. To calculate the dropout area percentage of each eyelid, the investigator analyzes the images by utilizing the ImageJ software. | Baseline, week 4, week 8, week 12 | |
Secondary | Meibomian gland morphology | Meibomian gland morphology includes:
Distorted glands: glands not parallel to normal glands with torsion =45° Tortuous glands: glands not parallel to normal glands with torsion >45° Hooked glands: glands curling back at the distal end Overlapping glands These variables are binary variables (Yes/No) They are analyzed by meibography images taken by Keratograph 5M |
Baseline, week 4, week 8, week 12 | |
Secondary | Lipid layer thickness | Lipid layer thickness measurement by Lipiview interferometer. For each eye, a 20-second video will be recorded to quantify the thickness of tear film's lipid layer in interferometric color unit (ICU) which corresponds to 1 nanometer. Images are captured while the participant focuses on the internal target. They are allowed to blink naturally during this process. Patients should not use any artificial tear for at least 4 hours and should not use ointments for at least 24 hours prior to LipiView assessment. | Baseline, week 4, week 8, week 12 | |
Secondary | Lid margin abnormality | Lid margin abnormality score in upper and lower eyelid will be calculated by summing the score of 4 aspects:
Telangiectasia (0: No or slight redness in lid margin conjunctiva and no telangiectasia, 1: Redness in lid margin conjunctiva and no telangiectasia crossing meibomian gland orifices, 2: conjunctival redness and telangiectasia < 1/2 full length of the lid, 3: conjunctival redness and telangiectasia = 1/2 full length of the lid) Plugging (0: No plugging, 1: < 3 plugging, 2: =3 plugging with a distribution of <1/2 full length of the lid, 3: =3 plugging with a distribution of = 1/2 full length of the lid) Thickening (0: No thickening, 1: Lid margin thickening with or without localized rounding, 2: diffuse rounding) Irregularity (0: No irregularity, 1: <3 lid margin irregularities with shallow notching, 2: =3 lid margin irregularities or deep notching) |
Baseline, week 4, week 8, week 12 | |
Secondary | Meibum quality | The meibum quality score was conducted by Evaluator (TearScience). Meibum quality score is obtained by evaluate each of eight glands of the central third of the lower eyelid on a scale of 0 to 3 for each gland (0: clear, 1: cloudy, 2: Cloudy with debris (granular), 3: Thick, like toothpaste). Total score ranges from 0 to 24. | Baseline, week 4, week 8, week 12 | |
Secondary | Meibum expressibility | The meibum expressibility score was conducted by Evaluator (TearScience). Meibum expressibility is evaluated on a scale ranging from 0 to 3 for five glands of the lower eyelid. The assessment is based on the number of glands that can be expressed.
0: All glands, 1: 3-4 glands, 2: 1-2 glands, 3: no gland |
Baseline, week 4, week 8, week 12 | |
Secondary | Pain level | MGX group is assessed pain level by interview the patients within 15 minutes after the procedure by a numeric rating scale-11 (NRS-11). Pain levels ranges from 0 to 10 as follows: 0, no pain; 10, worst possible pain; 1 to 3, mild pain; 4 to 6, moderate pain; and 7 to 10, severe pain | Baseline, week 2, week 4, week 6, week 8, week 10 | |
Secondary | Adverse events | Adverse events will be questioned and recorded after the MGX and in every follow-up visit (week 4, week 8 and week 12) in both 2 groups. The examination using slit-lamp biomicroscopy to examine the eyelashes, eyelids, conjunctiva, cornea, anterior chamber, and lens is performed to detect any adverse events such as conjunctival congestion and eyelid puffiness, subconjunctival/lid hemorrhages, chalazion, acute conjunctivitis and keratitis. | week 4, week 8 and week 12 |
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