NCT05139511

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 1, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
Last Updated

October 18, 2022

Status Verified

October 1, 2022

Enrollment Period

2.2 years

First QC Date

November 4, 2021

Last Update Submit

October 17, 2022

Conditions

Meibomian Gland DysfunctionBlepharitis

Keywords

Intense pulsed lightLASIK / SMILE

Outcome Measures

Primary Outcomes (25)

  • 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

  • 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

  • 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

  • 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

  • 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

  • Lacrimal meniscus height

    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

    Measured in millimeters, a value greater than 0.20 mm is considered normal

    7 day

  • Change from Baseline Lacrimal meniscus height

    Measured in millimeters, a value greater than 0.20 mm is considered normal

    30 day

  • Change from Baseline Lacrimal meniscus height

    Measured in millimeters, a value greater than 0.20 mm is considered normal

    90 day

  • Change from Baseline Lacrimal meniscus height

    Measured in millimeters, a value greater than 0.20 mm is considered normal

    180 day

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (10)

  • Visual acuity

    0 day

  • Change from Baseline Visual acuity

    180 day

  • Corneal topography

    0 day

  • Change from Baseline Corneal topography

    180 day

  • Corneal aberrometry

    0 day

  • +5 more secondary outcomes

Study Arms (2)

Study group

EXPERIMENTAL

IPL + laser refractive surgery

Device: Study group

Control group

PLACEBO COMPARATOR

Laser refractive surgery without IPL

Other: Control group

Interventions

Study groupDEVICE

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.

Also known as: Intense pulsed light therapy (Lumenis M22)
Study group
Control groupOTHER

Same procedure but without energy

Control group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients over 18 years of age who are undergoing a corneal laser refractive surgery after a medical indication by the Vissum ophthalmologist

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alicante Vissum Miranza

Alicante, 03016, Spain

RECRUITING

Related Publications (9)

  • 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.

    PMID: 17216074RESULT

  • Toda I. Dry Eye After LASIK. Invest Ophthalmol Vis Sci. 2018 Nov 1;59(14):DES109-DES115. doi: 10.1167/iovs.17-23538.

    PMID: 30481814RESULT

  • 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.

    PMID: 32188437RESULT

  • 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.

    PMID: 26989003RESULT

  • 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.

    PMID: 11097583RESULT

  • 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.

    PMID: 11311627RESULT

  • 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.

    PMID: 20712970RESULT

  • 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.

    PMID: 32182637RESULT

  • 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.

    PMID: 29688838RESULT

MeSH Terms

Conditions

Meibomian Gland DysfunctionBlepharitisSmiling

Interventions

Intense Pulsed Light TherapyControl Groups

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye DiseasesFacial ExpressionNonverbal CommunicationCommunicationBehavior

Intervention Hierarchy (Ancestors)

PhototherapyTherapeuticsEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Jorge Alió del Barrio, MD, PhD

    Vissum Miranza

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY CHAIR

Central Study Contacts

Jorge Alió del Barrio, MD, PhD

CONTACT

965154062jorge_alio@hotmail.com

Alejandra Rodriguez, MSc, PhD

CONTACT

965154062clinicaltrials@vissum.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Clinical experimental controlled trial, double-blind in which participants will be randomized into 2 groups: a study group and a control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2021

First Posted

December 1, 2021

Study Start

February 15, 2021

Primary Completion

April 15, 2023

Study Completion

August 15, 2023

Last Updated

October 18, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Data will be anonymized by assigning a code file and only authorized personnel will have access to personally identifiable data. The highest levels of professional conduct and confidentiality will always be maintained, complying with Organic Law 3/2018, of December 5, on the Protection of Personal Data and guarantee of digital rights.

Locations

ES(1)