- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05139511
Analysis of the Results of Intense Pulsed Light Treatment Previously to Laser Refractive Surgery
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Design Clinical experimental controlled trial, double-blind in which participants will be randomized into 2 groups: a study group (IPL + laser refractive surgery) and a control group (laser refractive surgery without IPL).
The study will be conducted in accordance with Law 14/2007 of 3 July, on Biomedical Research, the Declaration of Helsinki (October 2013 version), standards of Good Clinical Practice and legislation in this area.
All participants included in the study should read the Information Sheet and sign the informed and voluntary consent.
Participants Participants from Vissum Clinic that present the inclusion criteria and none of the exclusion criteria.
The investigators will start the study with a preliminary project and depending on the results obtained, the investigators will apply these values to calculate the final sample size using the T-student-Fischer test for unilateral hypotheses and for a type 1 or α error of 5%. and a type 2 or β error of 20%.
Parameters evaluated Primary measures: age, sex, skin phototype, visual acuity with and without correction, refraction, cycloplegic refraction, OSDI and VAS questionnaire, use of artificial tears, oxford scale, lacrimal meniscus height, tear break-up time, conjunctival hyperemia, meibography and slit lamp examination.
Secondary measures: corneal topography and tomography (MS-39, CSO, Italy), corneal aberrometry (MS-39, CSO, Italy), ocular aberrometry (Osiris, CSO, Italy), analysis of contrast sensitivity (CSV-1000, Vector vision), photographic capture of the epithelial defect in PRK, pre-surgical and postsurgical photographic capture of the eyelid changes in PRK.
The measurement of the different objective variables will be carried out in the clinic. The measurement of the subjective variables will be carried out by two ophthalmologists, both masked.
Surgery and follow-up Participants who are candidates for a LASIK or SMILE procedure will receive, after randomization, IPL treatment in both eyes (experimental group) or sham IPL (control group). In the case of participant candidate for a PRK procedure, an intra-subject control group will be used, where one eye will receive the IPL treatment (right eyes) and the left contralateral eye the sham IPL treatment (control).
Refractive surgeries will be performed exclusively two ophthalmologists following the same surgical protocol.
IPL therapy (M22, Lumenis LTD, Israel) will be performed following the same protocol (standardized facial and periocular application with automatically adjusted energy according to Fitzpatrick skin classification). Three IPL sessions will be applied (simulated in the case of the control group): 7 days before the intervention, 7 days after the intervention, and 30 days after the intervention. The total postsurgical follow-up will be 6 months.
- Statistical analyses All demographic and clinical data will be collected in a database and analyzed with the SPSS statistical package for Windows version 22.0. A p <0.05% will be considered significant.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jorge Alió del Barrio, MD, PhD
- Phone Number: +34 965154062
- Email: jorge_alio@hotmail.com
Study Contact Backup
- Name: Alejandra Rodriguez, MSc, PhD
- Phone Number: +34 965154062
- Email: clinicaltrials@vissum.com
Study Locations
-
-
-
Alicante, Spain, 03016
- Recruiting
- Alicante Vissum Miranza
-
Contact:
- Alejandra E Rodriguez, MSc, PhD
- Phone Number: +34 965154062
- Email: clinicaltrials@vissum.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study group
IPL + laser refractive surgery
|
The IPL therapy consists in a polychromatic pulses of light not coherent and not collimated.
The therapy leads to a series of processes such as the destruction of superficial blood vessels and thus the reduction of local inflammation, the liquefy of the meibum and an antimicrobial, anti-inflammatory and antioxidant effects.
The therapy is performed over the cheeks, nose and upper eyelids.
Other Names:
|
Placebo Comparator: Control group
Laser refractive surgery without IPL
|
Same procedure but without energy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OSDI questionnaire
Time Frame: 0 day
|
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
|
Change from Baseline OSDI questionnaire
Time Frame: 7 day
|
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
|
Change from Baseline OSDI questionnaire
Time Frame: 30 day
|
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
|
Change from Baseline OSDI questionnaire
Time Frame: 90 day
|
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
|
Change from Baseline OSDI questionnaire
Time Frame: 180 day
|
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
|
Lacrimal meniscus height
Time Frame: 0 day
|
Measured in millimeters by Ocular Keratograph 5M, a value greater than 0.20 mm is considered normal
|
0 day
|
Change from Baseline Lacrimal meniscus height
Time Frame: 7 day
|
Measured in millimeters, a value greater than 0.20 mm is considered normal
|
7 day
|
Change from Baseline Lacrimal meniscus height
Time Frame: 30 day
|
Measured in millimeters, a value greater than 0.20 mm is considered normal
|
30 day
|
Change from Baseline Lacrimal meniscus height
Time Frame: 90 day
|
Measured in millimeters, a value greater than 0.20 mm is considered normal
|
90 day
|
Change from Baseline Lacrimal meniscus height
Time Frame: 180 day
|
Measured in millimeters, a value greater than 0.20 mm is considered normal
|
180 day
|
Tear Break-up-time
Time Frame: 0 day
|
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
|
Change from Baseline Tear Break-up-time
Time Frame: 7 day
|
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
|
Change from Baseline Tear Break-up-time
Time Frame: 30 day
|
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
|
Change from Baseline Tear Break-up-time
Time Frame: 90 day
|
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
|
Change from Baseline Tear Break-up-time
Time Frame: 180 day
|
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
|
Conjunctival and ciliary hyperemia.
Time Frame: 0 day
|
Grade of red eye measured by Ocular Keratograph 5M.
Jenvis ranking from 0 to 4 (normal, mild, moderate, severe)
|
0 day
|
Change from Baseline Conjunctival and ciliary hyperemia.
Time Frame: 7 day
|
Grade of red eye measured by Ocular Keratograph 5M.
Jenvis ranking from 0 to 4 (normal, mild, moderate, severe)
|
7 day
|
Change from Baseline Conjunctival and ciliary hyperemia.
Time Frame: 30 day
|
Grade of red eye measured by Ocular Keratograph 5M.
Jenvis ranking from 0 to 4 (normal, mild, moderate, severe)
|
30 day
|
Change from Baseline Conjunctival and ciliary hyperemia.
Time Frame: 90 day
|
Grade of red eye measured by Ocular Keratograph 5M.
Jenvis ranking from 0 to 4 (normal, mild, moderate, severe)
|
90 day
|
Change from Baseline Conjunctival and ciliary hyperemia.
Time Frame: 180 day
|
Grade of red eye measured by Ocular Keratograph 5M.
Jenvis ranking from 0 to 4 (normal, mild, moderate, severe)
|
180 day
|
Upper and lower meibography
Time Frame: 0 day
|
Measured by Oculus Keratograph 5M. Observes and evaluates morphological changes of the meibomian glands Meiboscore classification
|
0 day
|
Change from Baseline Upper and lower meibography
Time Frame: 7 day
|
Measured by Oculus Keratograph 5M. Observes and evaluates morphological changes of the meibomian glands Meiboscore classification
|
7 day
|
Change from Baseline Upper and lower meibography
Time Frame: 30 day
|
Measured by Oculus Keratograph 5M. Observes and evaluates morphological changes of the meibomian glands Meiboscore classification
|
30 day
|
Change from Baseline Upper and lower meibography
Time Frame: 90 day
|
Measured by Oculus Keratograph 5M. Observes and evaluates morphological changes of the meibomian glands Meiboscore classification
|
90 day
|
Change from Baseline Upper and lower meibography
Time Frame: 180 day
|
Measured by Oculus Keratograph 5M. Observes and evaluates morphological changes of the meibomian glands Meiboscore classification
|
180 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual acuity
Time Frame: 0 day
|
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
|
Change from Baseline Visual acuity
Time Frame: 180 day
|
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
|
Corneal topography
Time Frame: 0 day
|
Performs an analysis of the cornea, which allows evaluating the shape and quantifying the power of the different curvatures
|
0 day
|
Change from Baseline Corneal topography
Time Frame: 180 day
|
Performs an analysis of the cornea, which allows evaluating the shape and quantifying the power of the different curvatures
|
180 day
|
Corneal aberrometry
Time Frame: 0 day
|
Technique that analyzes complex systems of light waves to quantify the set of optical aberrations that exist within the ocular structure.
|
0 day
|
Change from Baseline Corneal aberrometry
Time Frame: 180 day
|
Technique that analyzes complex systems of light waves to quantify the set of optical aberrations that exist within the ocular structure.
|
180 day
|
Analysis of contrast sensitivity
Time Frame: 0 day
|
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
|
Change from Baseline Analysis of contrast sensitivity
Time Frame: 180 day
|
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
|
VAS questionnaire
Time Frame: 0 day
|
investigates the intensity of the ocular surface symptoms from 0 to 100 (normal- severe)
|
0 day
|
Change from Baseline VAS questionnaire
Time Frame: 180 day
|
investigates the intensity of the ocular surface symptoms from 0 to 100 (normal- severe)
|
180 day
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jorge Alió del Barrio, MD, PhD, Vissum Miranza
- Study Chair: Maria Martinez Hergueta, MD, Universidad Miguel Hernández
- Study Chair: Maria A Amesty, MD, PhD, Vissum Miranza
- Study Chair: Mario Cantó Cerdan, MSc, Vissum Miranza
- Study Chair: Alejandra Rodriguez, MSc, PhD, Vissum Miranza
- Study Chair: Jorge L Alió y Sanz, MD, PhD, Vissum Miranza
Publications and helpful links
General Publications
- Solomon R, Donnenfeld ED, Perry HD. The effects of LASIK on the ocular surface. Ocul Surf. 2004 Jan;2(1):34-44. doi: 10.1016/s1542-0124(12)70022-8.
- Toda I. Dry Eye After LASIK. Invest Ophthalmol Vis Sci. 2018 Nov 1;59(14):DES109-DES115. doi: 10.1167/iovs.17-23538.
- 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: 10.1186/s12886-020-01357-5.
- 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.
- Yu EY, Leung A, Rao S, Lam DS. Effect of laser in situ keratomileusis on tear stability. Ophthalmology. 2000 Dec;107(12):2131-5. doi: 10.1016/s0161-6420(00)00388-2.
- 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. doi: 10.1016/s0886-3350(00)00835-x.
- Nettune GR, Pflugfelder SC. Post-LASIK tear dysfunction and dysesthesia. Ocul Surf. 2010 Jul;8(3):135-45. doi: 10.1016/s1542-0124(12)70224-0.
- 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(3):CD013559. doi: 10.1002/14651858.CD013559.
- 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.2017.4402. Epub 2018 Apr 24.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IPL-2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Meibomian Gland Dysfunction
-
Hovione Scientia LimitedCompletedMeibomian Gland Dysfunction | MGD-Meibomian Gland DysfunctionUnited States
-
University of WaterlooCompletedMeibomian Gland Dysfunction (MGD)Canada
-
Aier School of Ophthalmology, Central South UniversityUnknownMeibomian Gland Massage is Important to Delay the Development of Meibomian Gland DysfunctionChina
-
Second Affiliated Hospital, School of Medicine,...Aier Eye Hospital, WuhanCompletedMGD-Meibomian Gland DysfunctionChina
-
Barzilai Medical CenterCompletedMGD-Meibomian Gland DysfunctionIsrael
-
Singapore National Eye CentreNational University, SingaporeCompleted
-
Johnson & Johnson Surgical Vision, Inc.CompletedCataracts | Meibomian Gland Dysfunction (MGD)United States
-
Azura OphthalmicsThe University of New South WalesCompletedMeibomian Gland Dysfunction (MGD) | Contact Lens Discomfort (CLD)Australia
-
Zhongnan HospitalRecruitingDry Eye | MGD-Meibomian Gland DysfunctionChina
-
Zhongnan HospitalRecruitingDry Eye | Positron-Emission Tomography | MGD-Meibomian Gland DysfunctionChina
Clinical Trials on Study group
-
Romanian Society of Anesthesia and Intensive CareUniversity of Medicine and Pharmacy "Victor Babes" Timisoara; Timişoara County...Completed
-
Muş Alparlan UniversityNot yet recruitingSTROKE REHABİLİTATİONTurkey
-
Medical University of GrazRoyal Alexandra HospitalCompletedBrain Injuries | Preterm Infant | Birth HypoxiaAustria, Canada, Ireland, Slovenia, Germany, Poland, Italy
-
Mehmet GÖĞREMİŞKahramanmaras Sutcu Imam UniversityCompletedFemale Patients Diagnosed With LDH at L4-S1Turkey
-
Alanya Alaaddin Keykubat UniversityCompletedTemporomandibular Joint Disorders | Physiotherapy | Vertigo, Paroxysmal | Soft Tissue Mobilisation | Vestibular ExercisesTurkey
-
Istanbul Sureyyapasa Chest Diseases and Chest Surgery...CompletedSleep Disorder | Obstructive Sleep Apnea of Adult | Patient ComplianceTurkey
-
Cairo UniversityCompletedCarpal Tunnel Syndrome
-
Loma Linda UniversityTerminatedType 1 Diabetes Mellitus
-
Medtronic BRCMedtronicCompletedAtrial Fibrillation | Sinus ArrhythmiaItaly
-
Université Libre de BruxellesCHU de CharleroiNot yet recruiting