Meibomian Gland Dysfunction Clinical Trial
Official title:
Analysis of the Efficacy and Safety of Intense Pulsed Light Treatment for the Ocular Surface in Patients Who Will Undergo Laser Refractive Surgery
Dry eye is often reported as the most common complication after a laser refractive surgery. Any refractive procedure can lead an impact on the corneal surface and the tear film. The main cause of this dry eye is the corneal denervation caused by the destruction of the anterior stromal nerves during the ablative procedure. This loss of corneal sensitivity leads to a decrease in the blink reflex, a decrease in the secretion rate of the meibomian glands and finally an evaporated dry eye. There is also a chronic inflammation at the corneal surface that produces an increase of inflammatory cytokines and a dysfunction of the meibomian glands. Yu et al have described incidences of dry eye closed to 60% after the first month of LASIK. Hovanesian et al have observed dry eye symptoms in 50% of patients 6 months after surgery. Donnenfeld et al describe 15% of moderate dry eye in the following 3 months and 5% of severe dry eye in the first 6 months. A small number of patients will present with chronic dry eye symptoms for more than 1 year. Bower et al analyzed its incidence in 0.8% Alterations in the tear film also decrease the quality of the retinal image and produce greater number of high-order due to the irregular. Pulsed light therapy (IPL) applied preoperatively in patients who undergo a laser refractive surgery may prevent the post-surgical dry eye and improve the refractive results. The aim of our study is to evaluate the usefulness of the applied therapy for the prevention of dry eye in patients that undergo a corneal refractive procedure.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | August 15, 2023 |
Est. primary completion date | April 15, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Patients over 18 years of age who are undergoing a corneal laser refractive surgery after a medical indication by the Vissum ophthalmologist Exclusion Criteria: - Pregnancy - Piercings - Fitzpatrick skin classification V and VI - Autoimmune diseases - Epilepsy - Previous history of herpes or ocular pathology - Pathological or suspicious corneal topography - Treatment in the previous month with corticosteroids, antihistamines or topical vasoconstrictors. |
Country | Name | City | State |
---|---|---|---|
Spain | Alicante Vissum Miranza | Alicante |
Lead Sponsor | Collaborator |
---|---|
Vissum, Instituto Oftalmológico de Alicante |
Spain,
Cote S, Zhang AC, Ahmadzai V, Maleken A, Li C, Oppedisano J, Nair K, Busija L, Downie LE. Intense pulsed light (IPL) therapy for the treatment of meibomian gland dysfunction. Cochrane Database Syst Rev. 2020 Mar 18;3:CD013559. doi: 10.1002/14651858.CD0135 — View Citation
Ge J, Liu N, Wang X, Du Y, Wang C, Li Z, Li J, Wang L. Evaluation of the efficacy of optimal pulsed technology treatment in patients with cataract and Meibomian gland dysfunction in the perioperative period. BMC Ophthalmol. 2020 Mar 18;20(1):111. doi: 10. — View Citation
Hovanesian JA, Shah SS, Maloney RK. Symptoms of dry eye and recurrent erosion syndrome after refractive surgery. J Cataract Refract Surg. 2001 Apr;27(4):577-84. — View Citation
Jung JW, Han SJ, Nam SM, Kim TI, Kim EK, Seo KY. Meibomian gland dysfunction and tear cytokines after cataract surgery according to preoperative meibomian gland status. Clin Exp Ophthalmol. 2016 Sep;44(7):555-562. doi: 10.1111/ceo.12744. Epub 2016 May 1. — View Citation
Nettune GR, Pflugfelder SC. Post-LASIK tear dysfunction and dysesthesia. Ocul Surf. 2010 Jul;8(3):135-45. Review. — View Citation
Rong B, Tang Y, Tu P, Liu R, Qiao J, Song W, Toyos R, Yan X. Intense Pulsed Light Applied Directly on Eyelids Combined with Meibomian Gland Expression to Treat Meibomian Gland Dysfunction. Photomed Laser Surg. 2018 Jun;36(6):326-332. doi: 10.1089/pho.2017 — View Citation
Solomon R, Donnenfeld ED, Perry HD. The effects of LASIK on the ocular surface. Ocul Surf. 2004 Jan;2(1):34-44. — View Citation
Toda I. Dry Eye After LASIK. Invest Ophthalmol Vis Sci. 2018 Nov 1;59(14):DES109-DES115. doi: 10.1167/iovs.17-23538. Review. — View Citation
Yu EY, Leung A, Rao S, Lam DS. Effect of laser in situ keratomileusis on tear stability. Ophthalmology. 2000 Dec;107(12):2131-5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | OSDI questionnaire | It measures the severity of ocular surface symptoms and includes 12 items organized into 3 subscales; eye discomfort, functionality and environmental factors. After completing the questionnaire, a final score is obtained that when it is higher than 13 indicates ocular surface pathology. | 0 day | |
Primary | Change from Baseline OSDI questionnaire | It measures the severity of ocular surface symptoms and includes 12 items organized into 3 subscales; eye discomfort, functionality and environmental factors. After completing the questionnaire, a final score is obtained that when it is higher than 13 indicates ocular surface pathology. | 7 day | |
Primary | Change from Baseline OSDI questionnaire | It measures the severity of ocular surface symptoms and includes 12 items organized into 3 subscales; eye discomfort, functionality and environmental factors. After completing the questionnaire, a final score is obtained that when it is higher than 13 indicates ocular surface pathology. | 30 day | |
Primary | Change from Baseline OSDI questionnaire | It measures the severity of ocular surface symptoms and includes 12 items organized into 3 subscales; eye discomfort, functionality and environmental factors. After completing the questionnaire, a final score is obtained that when it is higher than 13 indicates ocular surface pathology. | 90 day | |
Primary | Change from Baseline OSDI questionnaire | It measures the severity of ocular surface symptoms and includes 12 items organized into 3 subscales; eye discomfort, functionality and environmental factors. After completing the questionnaire, a final score is obtained that when it is higher than 13 indicates ocular surface pathology. | 180 day | |
Primary | Lacrimal meniscus height | Measured in millimeters by Ocular Keratograph 5M, a value greater than 0.20 mm is considered normal | 0 day | |
Primary | Change from Baseline Lacrimal meniscus height | Measured in millimeters, a value greater than 0.20 mm is considered normal | 7 day | |
Primary | Change from Baseline Lacrimal meniscus height | Measured in millimeters, a value greater than 0.20 mm is considered normal | 30 day | |
Primary | Change from Baseline Lacrimal meniscus height | Measured in millimeters, a value greater than 0.20 mm is considered normal | 90 day | |
Primary | Change from Baseline Lacrimal meniscus height | Measured in millimeters, a value greater than 0.20 mm is considered normal | 180 day | |
Primary | Tear Break-up-time | Time elapsed from the last blink to the appearance of the first tear discontinuity measured by Ocular Keratograph 5M. A title longer than 5 seconds is considered normal. | 0 day | |
Primary | Change from Baseline Tear Break-up-time | time elapsed from the last blink to the appearance of the first tear discontinuity measured by Ocular Keratograph 5M. A title longer than 5 seconds is considered normal. | 7 day | |
Primary | Change from Baseline Tear Break-up-time | time elapsed from the last blink to the appearance of the first tear discontinuity measured by Ocular Keratograph 5M. A title longer than 5 seconds is considered normal. | 30 day | |
Primary | Change from Baseline Tear Break-up-time | time elapsed from the last blink to the appearance of the first tear discontinuity measured by Ocular Keratograph 5M. A title longer than 5 seconds is considered normal. | 90 day | |
Primary | Change from Baseline Tear Break-up-time | time elapsed from the last blink to the appearance of the first tear discontinuity measured by Ocular Keratograph 5M. A title longer than 5 seconds is considered normal. | 180 day | |
Primary | Conjunctival and ciliary hyperemia. | Grade of red eye measured by Ocular Keratograph 5M. Jenvis ranking from 0 to 4 (normal, mild, moderate, severe) | 0 day | |
Primary | Change from Baseline Conjunctival and ciliary hyperemia. | Grade of red eye measured by Ocular Keratograph 5M. Jenvis ranking from 0 to 4 (normal, mild, moderate, severe) | 7 day | |
Primary | Change from Baseline Conjunctival and ciliary hyperemia. | Grade of red eye measured by Ocular Keratograph 5M. Jenvis ranking from 0 to 4 (normal, mild, moderate, severe) | 30 day | |
Primary | Change from Baseline Conjunctival and ciliary hyperemia. | Grade of red eye measured by Ocular Keratograph 5M. Jenvis ranking from 0 to 4 (normal, mild, moderate, severe) | 90 day | |
Primary | Change from Baseline Conjunctival and ciliary hyperemia. | Grade of red eye measured by Ocular Keratograph 5M. Jenvis ranking from 0 to 4 (normal, mild, moderate, severe) | 180 day | |
Primary | Upper and lower meibography | Measured by Oculus Keratograph 5M. Observes and evaluates morphological changes of the meibomian glands Meiboscore classification
Grade 0: no loss of meibomian glands. Grade 1: loss of less than 1/3 of the total surface of the meibomian glands. Grade 2: loss of 1/3 to 2/3 of the total area. Grade 3: loss of more than 2/3 of the surface. |
0 day | |
Primary | Change from Baseline Upper and lower meibography | Measured by Oculus Keratograph 5M. Observes and evaluates morphological changes of the meibomian glands Meiboscore classification
Grade 0: no loss of meibomian glands. Grade 1: loss of less than 1/3 of the total surface of the meibomian glands. Grade 2: loss of 1/3 to 2/3 of the total area. Grade 3: loss of more than 2/3 of the surface. |
7 day | |
Primary | Change from Baseline Upper and lower meibography | Measured by Oculus Keratograph 5M. Observes and evaluates morphological changes of the meibomian glands Meiboscore classification
Grade 0: no loss of meibomian glands. Grade 1: loss of less than 1/3 of the total surface of the meibomian glands. Grade 2: loss of 1/3 to 2/3 of the total area. Grade 3: loss of more than 2/3 of the surface. |
30 day | |
Primary | Change from Baseline Upper and lower meibography | Measured by Oculus Keratograph 5M. Observes and evaluates morphological changes of the meibomian glands Meiboscore classification
Grade 0: no loss of meibomian glands. Grade 1: loss of less than 1/3 of the total surface of the meibomian glands. Grade 2: loss of 1/3 to 2/3 of the total area. Grade 3: loss of more than 2/3 of the surface. |
90 day | |
Primary | Change from Baseline Upper and lower meibography | Measured by Oculus Keratograph 5M. Observes and evaluates morphological changes of the meibomian glands Meiboscore classification
Grade 0: no loss of meibomian glands. Grade 1: loss of less than 1/3 of the total surface of the meibomian glands. Grade 2: loss of 1/3 to 2/3 of the total area. Grade 3: loss of more than 2/3 of the surface. |
180 day | |
Secondary | Visual acuity | Visual acuity with and without correction, measured on a decimal scale, determined by the Snellen panel, placing the examined person at a distance of 6 meters, will be collected by an optician. | 0 day | |
Secondary | Change from Baseline Visual acuity | Visual acuity with and without correction, measured on a decimal scale, determined by the Snellen panel, placing the examined person at a distance of 6 meters, will be collected by an optician. | 180 day | |
Secondary | Corneal topography | Performs an analysis of the cornea, which allows evaluating the shape and quantifying the power of the different curvatures | 0 day | |
Secondary | Change from Baseline Corneal topography | Performs an analysis of the cornea, which allows evaluating the shape and quantifying the power of the different curvatures | 180 day | |
Secondary | Corneal aberrometry | Technique that analyzes complex systems of light waves to quantify the set of optical aberrations that exist within the ocular structure. | 0 day | |
Secondary | Change from Baseline Corneal aberrometry | Technique that analyzes complex systems of light waves to quantify the set of optical aberrations that exist within the ocular structure. | 180 day | |
Secondary | Analysis of contrast sensitivity | Contrast Sensitivity is a test that assesses a person's ability to identify an object and separate it from the background Contrast sensitivity is evaluated with charts that can be used as projected or wall acuity charts. | 0 day | |
Secondary | Change from Baseline Analysis of contrast sensitivity | Contrast Sensitivity is a test that assesses a person's ability to identify an object and separate it from the background Contrast sensitivity is evaluated with charts that can be used as projected or wall acuity charts. | 180 day | |
Secondary | VAS questionnaire | investigates the intensity of the ocular surface symptoms from 0 to 100 (normal- severe) | 0 day | |
Secondary | Change from Baseline VAS questionnaire | investigates the intensity of the ocular surface symptoms from 0 to 100 (normal- severe) | 180 day |
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