The Effect and Duration of Efficacy of Eyelid Margin Debridement on Signs and Secretions of Eyelids, Tear Film and Discomfort in Contact Lens Wearers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Lid Wiper Epitheliopathy
Study Overview
Brief Summary
In this study, clinical variables related to eyelids that potentially have an effect on contact lens discomfort will be investigated such as eyelid signs and secretions, eyelid sensitivity, eyelid microbiome, Demodex infestation and tear film properties. The main aim of this study is to understand the duration of efficacy of debridement of the eyelid margin and its impact on various eyelid signs (such as lid wiper epitheliopathy, lid-parallel conjunctival folds, eyelid sensitivity, meibomian gland morphology and meibum secretions, palpebral conjunctival reaction, eyelid microbiome and Demodex infestation, tear properties (both biophysical properties such as tear volume, tear meniscus height, tear evaporation, tear osmolarity and tear breakup time; and biochemical properties that are tear lipid analysis). To observe these variables, this study employs a cross-sectional design to study the effect of treatment at three instances, that is at baseline and two follow-up visits.
Detailed Description
Contact lens discomfort (CLD) is a substantial problem experienced frequently by contact lens wearers and it is the primary factor associated with permanent discontinuation of lens wear. Studies report that between 43% and 72% of contact lens wearer's dropout due to discomfort. Reducing the number of contact lens (CL) patient dropouts has been a continuing challenge for eye care professionals. With more than 125 million contact lens wearers around the world, patient discontinuations can have a considerable economic impact on an eye care practice.
Definition: Contact lens discomfort is a condition characterized by episodic or persistent adverse ocular sensations related to lens wear, either with or without visual disturbance, resulting from reduced compatibility between the contact lens and the ocular environment, which can lead to decreased wearing time and discontinuation of contact lens wear.
Inferences from our earlier study (HC15119) showed that eyelid margin debridement significantly improves eyelid signs, tear film properties and comfort in contact lens wearers. But the previous study did not consider the duration of efficacy as the subjects were only followed up once after 7-10days from treatment. Observing subjects more frequently will help us understand the duration of efficacy of debridement therapy. Also, the previous study did not examine the biochemical changes to tear film lipids that are produced by the eyelids.
It is hypothesized that debridement of eyelid margins improves lipid secretions that then help to form a stable lipid layer over ocular surface, thereby improving the tear evaporation dynamics and comfort in contact lens wearers.
Aim: The aim of the study is to observe the duration of efficacy of debridement of the eyelid margins in improving secretions from eyelid glands and whether the debridement helps to form a stable tear film over ocular surface, thereby improving comfort in contact lens wearers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The clinical signs are photographed and an outcomes accessor grades the clinical signs. This process ensures that there is no bias in recording the results. This method was specially chosen, due to the lack or inability to mask the treatment procedures, due to their nature of treatment.
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age of 18 years or above
- •Understand their rights as a research subject
- •Willing and able to sign a statement of informed consent
- •Normal ocular status, defined as a minimum of 20/40 visual acuity in each eye; clear corneas without scarring, opacities, or vascularization, as determined by biomicroscopic examination
- •Normal external examination
- •Normal puncta without punctal plugs
- •Ability to cooperate with the required procedures of diagnostic agent installation, eyelid eversion, and examination.
- •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. These contact lens wearers will be on daily wearing modality, where the subject is supposed to wear it for at least for 6 hours, only during the day and remove the lenses during sleep.
Exclusion Criteria
- •Any ocular or systemic disease that might influence the tear film and especially subjects with a history of episodes of epilepsy.
- •Subjects with eyelid inflammation of more than grade 2 will be excluded from the study as they need therapeutic intervention.
- •All conjunctival abnormalities, including pingueculae greater than 1 mm in diameter, location closer than 2 mm to the limbus, or elevated more than 0.2 mm
- •All forms of conjunctivitis, including allergic conjunctivitis
- •Fluorescein corneal staining of grade 2 or more, after a single installation of non-preserved fluorescein solution followed by examination 1 minute after installation
- •Current ocular infection or treatment of such infections with ocular or systemic medications
- •Current use of any prescription or non-prescription ocular or systemic medications, including antihistamines
- •Use of artificial tear preparations during the period 2 hours before the examination
- •Use of any ocular ointment during the 3 days before the examination
- •Any history of ocular surgery
Arms & Interventions
Microblepharon Exfoliation
This treatment is provided using BlephEx tool from Optimed Pty Ltd.
Intervention: BlephEx (Device)
Eyelid cleansing using Lid Hygenix
Foam-based hypoallergenic cleanser used as a control treatment in this study.
Intervention: Lid Hygenix (Other)
Outcomes
Primary Outcomes
Lid Wiper Epitheliopathy
Time Frame: 5 minutes
The eyelids will be examined using a slit lamp before and after instillation of sodium fluorescein. This stain helps to disclose changes to the eyelid surface .
Secondary Outcomes
- End of the Day Discomfort Rating(30 minutes)
- Demodex Infestation(15 minutes)
- LipiView Interferometry(10 minutes)
- Discomfort Rating - CLDEQ-8 Questionnaire(5 minutes)
- Tear Analysis(15 minutes)
- Lid Sensitivity(5 minutes)
- Tear Osmolarity(5 minutes)
- Meibography(5 minutes)
- Meibum Analysis(10 minutes)
- Lid Microbiota(5 minutes)
Investigators
Jaya Sowjanya Siddireddy
Ms
The University of New South Wales