Dry Eye Clinical Trial
Official title:
Using Impression Cytology to Observe the Cytological Changes of Ocular Surface Cells in Various Ocular Surface Disorders
Currently, due to the advantage of noninvasive, localized, rapid, painless and easily repeatable of impression specimens, the technique is an ideal method of investigating ocular surface disorders when the diagnosis is not clinically obvious or detecting the post-operative change without tissue damage. Using impression cytology for primary diagnosis and follow-up of ocular surface squamous neoplasia, including after therapy with topical mitomycin C has been well-studied. [29]. In addition to the applications described above, pterygium is another disease of interest. Pterygium, a common disease of ocular surface, has high recurrence rate after surgical excision. [30-33] However, the exact etiology and mechanism for recurrence is unknown. A transformation of the phenotypic characteristics of the conjunctival fibroblasts may play an important role. Due to the concern of improvement in treatment, it is important to explore the change of cytomorphology after pterygium operation, to identify the risk factors of developing recurrence, and, furthermore, to clarify the etiology and mechanism. Some ophthalmologists may think this procedure too time-consuming to be a routine examination in outpatient clinics. [34] However, National Taiwan University Hospital (NTUH), as one of the largest tertiary medical centers in Taiwan, is now in charge of a big part of difficult cases of ocular surface. With the need of further precise diagnosis and delicate clinical skills, the investigators are competent for this meaningful program.
Impression cytology is a simple, noninvasive technique that has been widely used to aid in
the diagnosis of several disorders of the ocular surface. The first use of impression
cytology specimens for diagnosis of ocular surface squamous neoplasia was reported in France
in 1954 by Larmande and Timsit. [1] In the English language literature, Egbert et al [2] in
1977 documented the use of cellulose acetate filters to detect goblet cell density in
patients with the dry eye syndrome. Traditionally, the cytology specimens were obtained by
pressing cellulose acetate (Millipore) filters onto the surface of the globe, then air-dried
and stained with PAS. [2] The procedure is usually painless even without anesthesia. The
filters remove 1 to 3 superficial cell layers of conjunctiva and cornea.
Since its first applications in ocular surface squamous neoplasia and dry eye syndrome,
[1,2] the use of impression cytology has expanded to include the staging of conjunctival
squamous metaplasia, [3,4] diagnosis of ocular surface squamous neoplasia, [5-11] and
follow-up of ocular surface squamous neoplasia after topical mitomycin-C, [10] limbal
stem-cell deficiency, [12,13] specific viral infections, [14-16] vitamin A deficiency,
[17,18] epithelial cell storage disorders, [19] allergic disorders, [19] conjunctival
melanosis and malignant melanoma, [20] and psoriasis [21]. The technique has the additional
advantage of preserving limbal stem cells, which occur in the basal layer of the limbal
epithelium and are responsible for renewal of the corneal epithelium throughout life. Since
ocular surface squamous neoplasia preferentially involves the limbus, limbal stem cells are
potentially reduced in number with each surgical biopsy. The progressive loss of limbal stem
cells results in limbal stem-cell deficiency, conjunctivalization of the cornea with corneal
opacity. Thus, impression cytology offers a safer alternative to diagnosis than repeated
biopsies.
With impression cytology, the morphology of the corneal and conjunctival epithelial cells,
their staining behavior, and nuclear/cytoplasmic ratio could be observed in detail. Other
important characteristics such as goblet cell density, the degree of keratinization of the
epithelial cells, the quality of the cell-to-cell cohesion, and the condensation of the
nuclear chromatin could also be detected through proper specimens. [3, 22-26] Furthermore,
with the improvement of immunocytochemical staining and confocal microscopy, specimens of
impression cytology can be further analyzed for complicated ocular disorder such as
cytokeratins 3 and 19 are useful in classification of limbal stem cell deficiency [27] and
mucin secretion of goblet cells can be evaluated by confocal microscopy [28].
;
Observational Model: Case-Only, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05102409 -
An Exploratory Clinical Trial to Assess Safety and Tolerability in Subjects With Dry Eye Disease
|
Phase 2 | |
Completed |
NCT06159569 -
Performance and Tolerability of the Medical Device LACRIACT
|
N/A | |
Completed |
NCT05027087 -
The Effect of a Novel Blueberry Supplement on Dry Eye Disease
|
Phase 3 | |
Completed |
NCT04081610 -
Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution
|
Phase 1 | |
Completed |
NCT05062564 -
Efficacy of LipiFlow in Patients Affected by Meibomian Gland Dysfunction in Reducing Post-cataract Surgery Dry Eye
|
N/A | |
Completed |
NCT05825599 -
PMCF Study to Evaluate Performance and Safety of "HPMC-based Eyedrops" Used to Relieve Dry Eye Symptoms
|
N/A | |
Completed |
NCT03418727 -
Dry Eye Disease Study With Brimonidine
|
Phase 2 | |
Active, not recruiting |
NCT04425551 -
Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction
|
N/A | |
Recruiting |
NCT04527887 -
Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease (DEcIDED)
|
Phase 4 | |
Not yet recruiting |
NCT06379685 -
Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface.
|
Phase 1 | |
Active, not recruiting |
NCT05618730 -
Safety, Tolerability, Plug Retention and Preliminary Efficacy of Tacrolimus-loaded Punctal Plug in Patients With Moderate to Severe Dry Eye Disease - Cohort B
|
Phase 1 | |
Completed |
NCT04553432 -
Dry Eye OmniLenz Application of Omnigen Research Study
|
Phase 4 | |
Recruiting |
NCT04109170 -
Dry Eye Evaluation System Based on Bioinformatics
|
||
Completed |
NCT04105842 -
Refitting Daily Disposable Contact Lens Wearers With Dry Eye Disease With A Different Daily Disposable Lens Type
|
N/A | |
Completed |
NCT05505292 -
Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers
|
Phase 4 | |
Completed |
NCT04668131 -
Study on Curative Effect and Mechanism of Acupuncture on Neuropathic Pain in Dry Eye Disease
|
N/A | |
Completed |
NCT06176651 -
Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in Habitual Contact Lens Wearers
|
Phase 4 | |
Not yet recruiting |
NCT02218827 -
Topical Steroid Treatment For Dry Eye
|
N/A | |
Completed |
NCT02235259 -
Efficacy and Safety of XG-104 for the Treatment of Dry Eye
|
Phase 2 | |
Completed |
NCT01959854 -
Efficacy of Topical 0.2% Xanthan Gum in Patients With Dry Eye
|
N/A |