Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04608942
Status:
UNKNOWN
Last Update Posted:
2020-10-30
First Post:
2020-09-20
Brief Title:
Refractory Meibomian Gland Dysfunction and Plasma Jet
Sponsor:
Federal University of São Paulo
Organization:
Federal University of São Paulo
Study Overview
Official Title:
Plasma Jet Approach for Refractory Meibomian Gland Dysfunction Patients
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
PURPOSE The investigators propose a new treatment for refractory Meibomian Gland Dysfunction MGD patients with plasma jet to remove the hyperkeratinization layer from the lid margin to unblock terminal gland ducts and use thermal stimulation to enhance meibum delivery
METHODS A prospective interventional clinical safety and efficacy trial with 25 patients from the Department of Ophthalmology at Escola Paulista de Medicina UNIFESP to determine the efficacy and safety of the treatment of refractory MGD patients with plasma jet on both upper and lower lids Patients will be submitted to an ophthalmology workup with best-corrected visual acuity BCVA ETDRS chart and dry eye questionnaires DEQ-5 and OSDI Bulbar redness tear film meniscus height noninvasive breakup time NIKBUT meibography under infrared light will be measured with Keratograph Oculus Following tear film osmolarity i-PenTM meibomian gland expression and Marx line assessment All exams were performed at the baseline 30 days and 90 days after the plasma jet application
METHODS A prospective interventional clinical safety and efficacy trial with 25 patients from the Department of Ophthalmology at Escola Paulista de Medicina UNIFESP to determine the efficacy and safety of the treatment of refractory MGD patients with plasma jet on both upper and lower lids Patients will be submitted to an ophthalmology workup with best-corrected visual acuity BCVA ETDRS chart and dry eye questionnaires DEQ-5 and OSDI Bulbar redness tear film meniscus height noninvasive breakup time NIKBUT meibography under infrared light will be measured with Keratograph Oculus Following tear film osmolarity i-PenTM meibomian gland expression and Marx line assessment All exams were performed at the baseline 30 days and 90 days after the plasma jet application
Detailed Description:
INTRODUCTION Dry eye disease DED is one of the most prevalent conditions at an ophthalmology office that may reach 15 to 40 of prevalence in the population It is didactically classified as two forms that exist as a continuum aqueous deficient dry eye ADDE and evaporative dry eye EDE In EDE patients Meibomian Gland Dysfunction MGD is the major etiology in which the insufficient meibum secretion can be decreased by cicatricial trachoma ocular pemphigoid erythema multiforme and non-cicatricial causes skin disorders such as acne rosacea and atopic dermatitis blepharitis
MGD pathophysiology can be explained by hyposecretion or ducts obstruction resulting in low delivery of phospholipids and cholesterol that grant stability to the tear film Hyposecretion of the sebaceous glands can result from intrinsic age ethnicity hormonal profile and extrinsic factors chronic blepharitis Demodex folliculorum infestation contact lens wear topical drops Furthermore the duct obstruction occurs in a consequence to cicatricial rearrangement of the terminal ducts or by non-cicatricial hyperkeratinization of the lid margins leading to increased duct pressure dilatation and disuse atrophy of the glands
Questionnaires such as Ocular Surface Disease Index OSDI and Dry Eye Questionnaire-5 DEQ-5 that evaluate the grade of severity of DED and assessment of MGD by noninvasive tear breakup time BUT evaluation that measures tear film stability and by meibography under infrared light that analyses gland vitality are central when dealing with any EDE patient
The treatment of MGD can be very challenging in cases where a clinical approach with non-preserved ocular lubricants lid hygiene and warm compresses are not sufficient Oral tetracyclines can be a good alternative in cases of evident lid inflammation to reduce bacterial colonization and inhibit collagenase action although long-term use intolerance limits its use
Thermodynamic treatment with a device that performs controlled local heating and massage of the ducts showed clinical improvement and symptoms reduction whereas multiple sessions are necessary Mechanical debridement of gland ducts terminals with scalpel blade also improved ocular symptoms and gland function of patients with EDE with MGD A combination of intense pulsed light IPL therapy and gland expression has been shown to be an effective treatment to MGD with increases in BUT and improvement of ocular symptoms related to DED
Plasma jet has been successfully used in Dermatology and is an increasingly popular method for smoothing wrinkles blunt blepharoplasty as well as performing thermal ablation for superficial skin layers
The investigators propose a new treatment for refractory MGD patients with plasma jet with a device used in Dermatology to remove the hyperkeratinization layer from the lid margin to unblock terminal gland ducts and use thermal stimulation to enhance meibum delivery
METHODS A prospective interventional clinical safety and efficacy trial to determine the efficacy and safety of the treatment of refractory MGD patients with plasma jet will be conducted at Ophthalmology Department at Escola Paulista de Medicina UNIFESP with 25 Caucasian patients
All patients will be instructed about the study design and will be given full access to the results at any time of the protocol All will sign an informed consent form and have their identity protected in accordance with patient medical confidentiality This case series is in accordance with Good Clinical Practices and the Declaration of Helsinki
Patients will be submitted to an ophthalmology workup with best-corrected visual acuity BCVA ETDRS chart dry eye questionnaires DEQ-5 and OSDI corneal topography bulbar redness tear meniscus height noninvasive breakup time NBUT tear film osmolarity meibography under infrared light meibomian gland expression and Marx line assessment All exams will be performed before and 30 days after the plasma jet application
Patients will be instructed about the procedure by the ophthalmologist and a nurse and the procedure will be performed after topical anesthesia with lidocaine 20 The plasma jet will be applied 3 times on both superior and inferior terminal gland ducts in the lid margins with a 144mm tip and intensity of 5 on the device 09W reaching only the superficial epidermis Patients will receive topical antibiotics and corticosteroids after the procedure During all periods 90 days patients will use sodium hyaluronate 015 and actinoquinol at the recommended dosage of twice a day
The software program GraphPad Prism version 70 will be used to conduct the statistical analyses Continuous data distribution will be verified by the Kolmogorov-Smirnov normality test Data will be analyzed by the Kruskal-Wallis test with the Wilcoxon test considering 2-time points for nonparametric variables and paired t-test for parametric variables All p values of 005 will indicate statistically significant differences
MGD pathophysiology can be explained by hyposecretion or ducts obstruction resulting in low delivery of phospholipids and cholesterol that grant stability to the tear film Hyposecretion of the sebaceous glands can result from intrinsic age ethnicity hormonal profile and extrinsic factors chronic blepharitis Demodex folliculorum infestation contact lens wear topical drops Furthermore the duct obstruction occurs in a consequence to cicatricial rearrangement of the terminal ducts or by non-cicatricial hyperkeratinization of the lid margins leading to increased duct pressure dilatation and disuse atrophy of the glands
Questionnaires such as Ocular Surface Disease Index OSDI and Dry Eye Questionnaire-5 DEQ-5 that evaluate the grade of severity of DED and assessment of MGD by noninvasive tear breakup time BUT evaluation that measures tear film stability and by meibography under infrared light that analyses gland vitality are central when dealing with any EDE patient
The treatment of MGD can be very challenging in cases where a clinical approach with non-preserved ocular lubricants lid hygiene and warm compresses are not sufficient Oral tetracyclines can be a good alternative in cases of evident lid inflammation to reduce bacterial colonization and inhibit collagenase action although long-term use intolerance limits its use
Thermodynamic treatment with a device that performs controlled local heating and massage of the ducts showed clinical improvement and symptoms reduction whereas multiple sessions are necessary Mechanical debridement of gland ducts terminals with scalpel blade also improved ocular symptoms and gland function of patients with EDE with MGD A combination of intense pulsed light IPL therapy and gland expression has been shown to be an effective treatment to MGD with increases in BUT and improvement of ocular symptoms related to DED
Plasma jet has been successfully used in Dermatology and is an increasingly popular method for smoothing wrinkles blunt blepharoplasty as well as performing thermal ablation for superficial skin layers
The investigators propose a new treatment for refractory MGD patients with plasma jet with a device used in Dermatology to remove the hyperkeratinization layer from the lid margin to unblock terminal gland ducts and use thermal stimulation to enhance meibum delivery
METHODS A prospective interventional clinical safety and efficacy trial to determine the efficacy and safety of the treatment of refractory MGD patients with plasma jet will be conducted at Ophthalmology Department at Escola Paulista de Medicina UNIFESP with 25 Caucasian patients
All patients will be instructed about the study design and will be given full access to the results at any time of the protocol All will sign an informed consent form and have their identity protected in accordance with patient medical confidentiality This case series is in accordance with Good Clinical Practices and the Declaration of Helsinki
Patients will be submitted to an ophthalmology workup with best-corrected visual acuity BCVA ETDRS chart dry eye questionnaires DEQ-5 and OSDI corneal topography bulbar redness tear meniscus height noninvasive breakup time NBUT tear film osmolarity meibography under infrared light meibomian gland expression and Marx line assessment All exams will be performed before and 30 days after the plasma jet application
Patients will be instructed about the procedure by the ophthalmologist and a nurse and the procedure will be performed after topical anesthesia with lidocaine 20 The plasma jet will be applied 3 times on both superior and inferior terminal gland ducts in the lid margins with a 144mm tip and intensity of 5 on the device 09W reaching only the superficial epidermis Patients will receive topical antibiotics and corticosteroids after the procedure During all periods 90 days patients will use sodium hyaluronate 015 and actinoquinol at the recommended dosage of twice a day
The software program GraphPad Prism version 70 will be used to conduct the statistical analyses Continuous data distribution will be verified by the Kolmogorov-Smirnov normality test Data will be analyzed by the Kruskal-Wallis test with the Wilcoxon test considering 2-time points for nonparametric variables and paired t-test for parametric variables All p values of 005 will indicate statistically significant differences
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