Using Impression Cytology to Observe the Cytological Changes of Ocular Surface Cells in Various Ocular Surface Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01387971
Recruitment Status : Unknown
Verified April 2011 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : July 6, 2011
Last Update Posted : July 6, 2011
Information provided by:
National Taiwan University Hospital

Brief Summary:
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.

Condition or disease
Pterygium Dry Eye Tumor

Detailed Description:

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].

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Using Impression Cytology to Observe the Cytological Changes of Ocular Surface Cells in Various Ocular Surface Disorders
Study Start Date : September 2009
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : August 2012

ocular surface disorders
various ocular surface disorders

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
various ocular surface disorders

Inclusion Criteria:

  • various ocular surface disorders

Exclusion Criteria:

  1. cognitive function disorder
  2. extremely ocular surface discomfort

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01387971

Contact: Wei-Li Chen, MD 886-2-23123456 ext 65206

National Taiwan University Hospital, department of Ophthalmology Recruiting
Taipei, Taiwan, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Wei-Li Chen, PhD National Taiwan University Hospital, department of Ophthalmology

Responsible Party: We-Li Chen , MD, Natinal Taiwan University Hospital Identifier: NCT01387971     History of Changes
Other Study ID Numbers: 200910001R
First Posted: July 6, 2011    Key Record Dates
Last Update Posted: July 6, 2011
Last Verified: April 2011

Keywords provided by National Taiwan University Hospital:
impression cytology
ocular surface disorders
ocular surface cells' variation
Limbal insufficiency

Additional relevant MeSH terms:
Conjunctival Diseases
Eye Diseases