None listed
Conditions
Brief summary
Approximately 150 million people wear contact lenses (CL) globally . Of these, 50% experience discomfort during contact lens wear and 25% of wearers are likely to discontinue wear permanently. The etiology of contact lens discomfort (CLD) is multifactorial and could be due to reduced compatibility between CL and the ocular environment. Intense Pulsed light therapy has been proven to be an effective therapy for improvement of signs and symptoms of dry eye disease, but it has not been fully evaluated as a treatment for contact lens discomfort. This project aims to evaluate the qualitative and quantitative change in signs and symptoms of Contact lens discomfort (CLD) and Meibomian gland dysfunction (MGD) following Intense Pulsed Light (IPL) treatment in Contact lens wearers. The research hypotheses is that Intense pulsed light (IPL) therapy will improve the signs and symptoms of CLD and MGD in contact lens wearers. This study designed as single centre, randomised, double masked trial, and consists of three visits. At the first visit, screening will be performed to determine the eligibility to take part in the study, If eligible, various clinical procedures will be conducted, followed by random allocation to one of the two treatments (Intense pulsed light or sham treatment) with Meibomian gland expression. The primary outcome is an improvement in Contact lens dry eye questionnaire -8 (CLDEQ-8) symptoms score following Intense pulsed light therapy in contact lens wearers. The secondary outcome is an improvement in tear break up time and Meibomian gland expression following intense pulsed light therapy in contact lens wearers .
Interventions
The aim of the research is to measure qualitative and quantitative differences in signs and symptoms of contact lens discomfort following Intense Pulsed Light (IPL) therapy.
IPL treatment will be delivered with a handpiece held by the investigator.
In this trial we will be using Intense Pulsed light (IPL) treatment for contact lens discomfort. The IPL emits light wavelength ranges from 515 to 1200 nm. A 560-nm filter will be adjusting for appropriate setting (range of 11–14 J/cm2) to a specifi
The aim of the research is to measure qualitative and quantitative differences in signs and symptoms of contact lens discomfort following Intense Pulsed Light (IPL) therapy. IPL treatment will be delivered with a handpiece held by the investigator. In this trial we will be using Intense Pulsed light (IPL) treatment for contact lens discomfort. The IPL emits light wavelength ranges from 515 to 1200 nm. A 560-nm filter will be adjusting for appropriate setting (range of 11–14 J/cm2) to a specific participant, trained optometrists (unmasked investigator) determines the skin type, and adjust the IPL settings according to the skin type and the condition to treat. Before the treatment begins, both eyes must be protected with goggles or disposable eye patches, and a thin layer of transparent gel must be spread on the treatment area . This treatment will be given on periocular are surrounding the eyelids on each eye 30 shots for the duration of 5mins.This procedure will be conducted on two visits, baseline and following after 3weeks visit (1st follow up visit) to the participants and the procedure will conducted at Eye Research Group clinic suites, School of optometry and Vision Science, University of New South Wales, Sydney.
Sponsors
University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
•Age of 18 years and above •Willing to sign informed consent and comply with study schedule. •Normal vision defined as a minimum of 20/40 best corrected visual acuity in each eye. •Healthy ocular surface, defined as no fluorescein corneal staining of grade 2 or more after a single instillation of non-preserved fluorescein solution followed by examination 1 minute after installation, considering minimal staining of grade 1 as normal in contact lens wearers. •Normal external ocular examination with no eyelid deformation •Ability to cooperate with and undergo the required study procedures. •Contact lens wearers who have worn lenses for at least 6 months, used contact lenses for 3 weeks before the evaluation visit and used these lenses at least four times a week. Contact lenses should have been worn on a daily wear modality, where the lenses are worn for at least of 6 hours per day and remove the lenses before sleep. •Experience symptoms of contact lens discomfort (CLD), defined as CLDEQ-8 Questionnaire score more than 13.
Exclusion criteria
•Any ocular or systemic disease that might influence the tear film •All forms of conjunctivitis, including allergic conjunctivitis •Any history of previous ocular surgery or trauma, including chalazion excision, oculoplastic surgery. •History of eyelid and periorbital skin disease or allergies in the past 1 month. •History of herpes zoster infection and any viral infection episode before. •Pregnancy, breast feeding •Skin cancer, user of photosensitive drugs /foods •Dark or deeply pigmented skin (Skin Fitzpatrick scale V/VI), which can be prone skin damage, such as discoloration or scarring after IPL treatment. •Current use of any prescription on nonprescription ocular or systemic medications, including antihistamines. •Use of artificial tear preparations during the period 4 hours before all visits •Use of any ocular ointment during the 3 days before any study visit. •Have an history of epilepsy and migraine •Have any history of previous IPL treatment for dry eye.
Outcome results
None listed