Analysis of the Results of Intense Pulsed Light Treatment Previously to Laser Refractive Surgery

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.

Conditions

• Meibomian Gland Dysfunction
• Blepharitis

Interventions

DEVICE

Study group

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

Control group

Same procedure but without energy

Sponsors & Collaborators

• Vissum, Instituto Oftalmológico de Alicante

  lead OTHER

Principal Investigators

• Jorge Alió del Barrio, MD, PhD · Vissum Miranza

• Maria Martinez Hergueta, MD · Universidad Miguel Hernández

• Maria A Amesty, MD, PhD · Vissum Miranza

• Mario Cantó Cerdan, MSc · Vissum Miranza

• Alejandra Rodriguez, MSc, PhD · Vissum Miranza

• Jorge L Alió y Sanz, MD, PhD · Vissum Miranza

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-02-15

Primary Completion

2023-04-15

Completion

2023-08-15

Countries

• Spain

Study Locations