Evaluation of epithelial cell proliferative activity and fibroblasts nucleus cariometry in recurrent pterygium previously treated with mitomycin C
| ISRCTN | ISRCTN82504082 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82504082 |
| Secondary identifying numbers | Brazil - Ethics Protocol No: 003186/04 |
- Submission date
- 12/10/2006
- Registration date
- 19/10/2006
- Last edited
- 06/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Gildasio Almeida Junior
Scientific
Scientific
Rua Antonio de Godoi, 3423 ap 41
São José do Rio Preto
15015-100
Brazil
Study information
| Study design | Randomised single-blind placebo-controlled cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Evaluation of epithelial cell proliferative activity and fibroblasts nucleus kariometry in recurrent pterygium previously treated with mitomycin C |
| Study acronym | The Mitomycin Trial |
| Study objectives | 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(s) | 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). |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | MitoMycin C (MMC) |
| Primary outcome measure | 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 study start date | 01/01/2005 |
| Completion date | 31/08/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 30 patients |
| Total final enrolment | 29 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 31/08/2005 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Rua Antonio de Godoi, 3423 ap 41
São José do Rio Preto
15015-100
Brazil
15015-100
Brazil
Sponsor information
Foundation for the Support of Education and Research (Fundação de Apoio ao Ensino, Pesquisa e Extensão [FAEPE]) (Brazil)
Hospital/treatment centre
Hospital/treatment centre
AV Brigadeiro Faria Lima, 5416
São Pedro
São José do Rio Preo
15090-000
Brazil
| Website | http://www.pesquisa.famerp.br/ |
|---|---|
"ROR" |
https://ror.org/04djvx395 |
Funders
Funder type
Hospital/treatment centre
Foundation for the Support of Education and Research (Fundação de Apoio ao Ensino, Pesquisa e Extensão [FAEPE]) - FAMERP (Brazil)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2008 | 06/01/2021 | Yes | No |
Editorial Notes
06/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
