Condition category
Eye Diseases
Date applied
12/10/2006
Date assigned
19/10/2006
Last edited
02/11/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Gildasio Almeida Junior

ORCID ID

Contact details

Rua Antonio de Godoi
3423 ap 41
São José do Rio Preto
15015-100
Brazil

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Brazil - Ethics Protocol No: 003186/04

Study information

Scientific title

Acronym

The Mitomycin Trial

Study hypothesis

This study aimed to compare the effectiveness of preventing recurrence by using MitoMycin C (MMC) by eyedrop topical administration and subconjunctival administration previous to Conjunctival Autograft Transplantation (CAT) surgery in cases of recurrence, and evaluating epithelial cell proliferation by the Ki –67 antigen as well as the evaluation of cariometry of conjunctive fibroblasts.

Ethics approval

Approved by FAMERP (Faculty of Medicine of São José do Rio Preto - São Paulo State) ethics committee on the 13th November 2004 (research protocol No 003186/04).

Study design

Randomised single-blind placebo-controlled cross-over study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Recurrent Pterygium

Intervention

Twenty-nine patients were randomly divided into three groups according to random numbers:
Group one: Nine patients submitted to CAT, using Placebo Eye-Drops (PED) 14 days before the surgery.
Group two: Eleven patients submitted to CAT, and administered subconjunctival injection of 0.1 ml of MMC 0.015% in the head of pterygium 30 days before surgery and PED 14 days before surgery.
Group three: Nine patients submitted to CAT, using MMC eyedrops of 0.02% 14 days before the surgery.

Intervention type

Drug

Phase

Not Specified

Drug names

MitoMycin C (MMC)

Primary outcome measures

1. The recurrence rate after six months follow-up
2. The epithelial cell proliferative activity using as marker the antigen Ki-67
3. Fibroblasts nucleus cariometry to evaluate the area and volume of the nucleus

Secondary outcome measures

To evaluate the safety and efficacy of MMC used topical or subconjunctival route before the surgery treatment of pterygium

Overall trial start date

01/01/2005

Overall trial end date

31/08/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Patients who presented symptoms of ocular irritation, photophobia and burning pain all concomitant with corneal invasion with more than 3 mm horizontal length, measured starting from the anatomical limbus.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

30 patients

Participant exclusion criteria

1. Patients with:
a. keratoconjuntivitis sicca
b. Sjögren disease
c. vernal keratoconjunctivitis
d. acne rosacea
e. neurothrophic keratopathy
f. severe dysfunction of the meibomius glands; patients with meibomius gland dysfunction with clinical indications (symptoms and signs), mild to moderate, were previously treated
2. Patients that use any immunosuppressive drug, through systemic and topical administration
3. Patients aged less than 18 years of age and vulnerable groups
4. Associated glaucoma and the use of ocular hypotensor

Recruitment start date

01/01/2005

Recruitment end date

31/08/2005

Locations

Countries of recruitment

Brazil

Trial participating centre

Rua Antonio de Godoi, 3423 ap 41
São José do Rio Preto
15015-100
Brazil

Sponsor information

Organisation

Foundation for the Support of Education and Research (Fundação de Apoio ao Ensino, Pesquisa e Extensão [FAEPE]) (Brazil)

Sponsor details

AV Brigadeiro Faria Lima
5416
São Pedro
São José do Rio Preo
15090-000
Brazil

Sponsor type

Hospital/treatment centre

Website

http://www.pesquisa.famerp.br/

Funders

Funder type

Hospital/treatment centre

Funder name

Foundation for the Support of Education and Research (Fundação de Apoio ao Ensino, Pesquisa e Extensão [FAEPE]) - FAMERP (Brazil)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=12750105&query_hl=2&itool=pubmed_docsum

Publication citations

  1. Donnenfeld ED, Perry HD, Fromer S, Doshi S, Solomon R, Biser S, Subconjunctival mitomycin C as adjunctive therapy before pterygium excision., Ophthalmology, 2003, 110, 5, 1012-1016, doi: 10.1016/S0161-6420(03)00091-5.

Additional files

Editorial Notes