This trial is active, not recruiting.

Condition tumor
Treatment punch biopsy
Sponsor University of Sao Paulo
Start date December 2008
End date October 2009
Trial size 40 participants
Trial identifier NCT00865813, 1143/07


The purpose of this study was to identify accuracy rates of 2mm punch biopsy technique in diagnosing periocular malignancy.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
punch biopsy Punch 2 mm
Instillation of anesthetic eye drops. Asepsis Placement of surgical cloths and drapes Infiltration of the involved region with anesthetic solution plus adrenalin in1:200.00 dilution. Trephination of the most typical area of the lesion with a punch (2mm in diameter) of stainless steel by applying gentle pressure and twisting the trephine until its introduction into the suspicious lesions Removal of the excised tissue with the aid of an insulin needle or conjuntival forceps, the base then bein cut with an number 11 surgical blade

Primary Outcomes

accuracy, positive predictive value, negative predictive value, sensitivity, specificity
time frame: In each case, the histology obtained at biopsy was compared with that identified at the time of tumor excision.

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - All lesions were initially examined at the slitlamp, after which lesions with malignant characteristics such as texture, size or color alterations asociated with ulceration, prominent borders or elevated contours, irregular borders, telangiectasias or loss of eyelashes were included. Exclusion Criteria: - Lesions with not malignant characteristics

Additional Information

Official title Biopsy Incisional With Trepan in Periocular Lesions
Principal investigator Rachel C Carneiro
Description In each case, the histology obtained at biopsy was compared with that identified at the time of tumor excision.
Trial information was received from ClinicalTrials.gov and was last updated in March 2009.
Information provided to ClinicalTrials.gov by University of Sao Paulo.