NCT01387971

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 6, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

July 6, 2011

Status Verified

April 1, 2011

Enrollment Period

2.9 years

First QC Date

July 1, 2011

Last Update Submit

July 5, 2011

Conditions

Keywords

impression cytologyocular surface disordersocular surface cells' variationLimbal insufficiency

Study Arms (1)

ocular surface disorders

various ocular surface disorders

Eligibility Criteria

Age12 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

various ocular surface disorders

You may qualify if:

  • various ocular surface disorders

You may not qualify if:

  • cognitive function disorder
  • extremely ocular surface discomfort

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital, department of Ophthalmology

Taipei, Taiwan, Taiwan

RECRUITING

MeSH Terms

Conditions

PterygiumDry Eye SyndromesNeoplasms

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye DiseasesLacrimal Apparatus Diseases

Study Officials

  • Wei-Li Chen, PhD

    National Taiwan University Hospital, department of Ophthalmology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 1, 2011

First Posted

July 6, 2011

Study Start

September 1, 2009

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

July 6, 2011

Record last verified: 2011-04

Locations