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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.
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.
We hypothesize 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 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.
Objectives To determine the effect of BlephEx - debridement therapy (an in-office eyelid treatment) on eyelid signs and secretions, tear film and contact lens discomfort.
To observe differences in discomfort in contact lens wearers To determine the duration of efficacy of BlephEx debridement therapy in contact lens wearers, by following up after 12-15 days and 22-25days from the baseline (Treatment) visit.
The study employs cross-sectional study design, to observe the effect of treatment at three instances, one baseline (treatment) visit and two follow-up visits. At the baseline visit, informed consent will be obtained from the subjects and assessment of the study variables will be performed. Subjects will undergo treatment on the same day with BlephEx. At baseline, the measurements are performed prior to treatment to record preliminary scores and then treatment is performed. Subjects are asked to return to the clinic for follow-up visits during which no treatment will be performed, but variables are assessed to determine the difference from baseline measurements. The 2nd visit will be after 12 -16 days after the baseline visit. The last follow-up will be 22-26 days after the baseline visit. All study variables will be assessed during all three visits to the clinic.
BlephEx is an instrument that contains a handpiece used to spin a medical grade micro-sponge along the edge of eyelids and lashes that helps in removing scurf and debris from eyelids and helps in exfoliating the lids. A new micro-sponge will be used for every subject to avoid cross-contamination. This procedure lasts for 6-8 mins.
Lid Hygenix, a commercially available formulated hypoallergenic foam cleanser will be used to moisten the BlephEx debridement tips.
Both the products are commercially available. The procedure is safe, painless and regularly performed by optometrists.
Study Procedures The study will be conducted in accordance with Declaration of Helsinki.
Discomfort will be measured using the CLDEQ-8 questionnaire that involves questions about subjects' experience of discomfort from past 2 weeks. This will be employed on all the study visits in the clinic.
End of the day discomfort will be assessed using a visual analog scale, where questions will be posed to participants about their level of comfort with contact lens wear at a specific time of day. This questionnaire will be a web-based survey, sent in the form of an email on the day before the baseline visit, and day 4, 9, 14, 19 and 24 from baseline visit. Explained clearly in the flowchart for study visits.
'Participant information sheet and informed consent' and 'web-based survey for the end of the day discomfort rating' will be sent out in the form of an email. Subjects who are interested in participation will respond to the survey and results will be used only after the subject signs the informed consent in the presence of the investigator, during the baseline visit. This survey response will be used as baseline data for the end of the day discomfort.
- The eyelids will be examined using a slit lamp before and after installation of sodium fluorescein. This stain helps to disclose changes to the eyelid surface.
- Lid Sensitivity: A Cochet Bonnet aesthesiometer will be used to assess the sensitivity thresholds of eyelids. This involves the use of a fine nylon thread to gently touch the eyelid. The thread length at which subject become aware of a sensation will be recorded. Subjects may feel nothing or a slight awareness of the thread on the eyelid.
- Confocal Microscopy: Highly magnified images of eyelids will be captured with a microscope. A lubricating tear gel will be placed in on the eye to enable the microscope probe to come into contact with eyelids and subject will be given an anesthetic drop to reduce any symptoms that may be associated with this procedure.
- Meibography: Meibomian gland (glands in eyelids) morphology will be studied using a non-contact meibographer which uses the infrared light source to observe and capture high-resolution images of meibomian glands.
- Lid Microbiota: Saline-moistened swabs will be gently rolled along the lid margin - and then sent to the microbiology laboratory for analysis of the types of microbes.
- Tear Osmolarity: An Ocusense TearLab osmometer will be used to measure tear osmolarity. The salt concentration of tears will be measured by collecting a very small amount of tears (less than a teardrop) from the lower eyelid using this sterile device.
- LipiView Interferometer: LipiView ocular surface interferometer measures the absolute thickness of the tear film lipid layer. It is an imaging device which uses infrared light to capture and store digital images of interferometric observations of the tear film which can be visually monitored and photographically documented.
- Phenol-Red Thread Test: The phenol-red thread will be used to assess the tear volume. The thread is inserted at lower eyelid margin and the subject asked to keep eyes open and blink normally for 15 seconds. The subject may feel a slight foreign body sensation when the thread is placed on the eye. The length of wetting of the thread is then measured after removal from the eye.
- Tear Evaporation: Evaporation rate of tears will be assessed using a vapometer. The vapometer is a portable non-invasive instrument used to assess the amount of tear evaporation based on an increase in relative humidity within a small chamber that is gently put around the eye.
- Tear Collection: Thin capillary micropipettes are placed at the temporal corner of the eye. Tears are then collected through capillary suction into the micropipettes and stored for further analysis.
- Meibum Collection: Meibomian glands at the eyelid margin secrete Meibum, that forms an important component of tear film that helps in preventing excessive evaporation of outer layer and maintains the stability of tears on the eye. Meibum will be collected using a sterile, single-use, golf spud by gently squeezing the eyelids against the eye, slightly everted outwards. Very minimal amount of meibum is expressed during this procedure and will not alter any of the normal functions of the tears. This meibum will then be stored for further analysis. Meibum and tear samples collected from the subjects will be stored in a -80º C freezer in the microbiology laboratory, Room No. 2.028, School of Optometry and Vision Science, UNSW.
All these study procedures will be repeated for each of the follow-up visits.
Contact Lens Discomfort
BlephEx, Lid Hygenix
Not yet recruiting
The University of New South Wales
Published on BioPortfolio: 2017-10-22T20:10:13-0400
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