Condition category
Eye Diseases
Date applied
14/10/2008
Date assigned
30/10/2008
Last edited
30/10/2008
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

Dr Augusto Paranhos

ORCID ID

Contact details

Federal University of Sao Paulo
Botucatu
824
Sao Paulo
04023-062
Brazil
augusto.paranhos@uol.com.br

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

0745/02

Study information

Scientific title

Use of prednisone for choroidal detachment after trabeculectomy: a double-masked randomised controlled trial

Acronym

Study hypothesis

To evaluate the treatment with oral prednisone for choroidal detachment after trabeculectomy.

Ethics approval

The Ethics Committee of the Federal University of Sao Paulo gave approval on the 27th November 2002.

Study design

Double-masked randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Choroidal detachment after trabeculectomy

Intervention

Oral prednisone 1 mg/kg daily for 7 days followed by a progressive reduction of 10 mg every 7 days. Patients in the placebo group received similar capsules containing starch for the same duration as the intervention group. Duration of the treatment ranged from 4 to 7 weeks.

Intervention type

Drug

Phase

Not Specified

Drug names

Prednisone

Primary outcome measures

Choroidal detachment resolution. Indirect ophthalmoscopy and ocular ultrasonography (B-mode) were performed weekly to evaluate the choroidal detachment until total reattachment of the choroid. The main outcome measure was the time elapsed between the detection of detachment and total reattachment of the choroid.

Secondary outcome measures

Intra-ocular pressure, evaluated every 5 days.

Overall trial start date

01/02/2003

Overall trial end date

01/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females, older then 18 years old
2. Primary open or narrow angle glaucoma submitted to trabeculectomy that developed choroidal detachment
3. Choroidal detachment should be diagnosed during the first two weeks after surgery
4. Choroidal detachment should be exudative by ultra-sound

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Other acute ocular disease
2. Positive Seidel test
3. Choroidal kissing
4. Athalamia
5. Clinical uncontrolled diabetes mellitus or systemic arterial hypertension
6. Hypersensitivity for any of the drugs components on the trial
7. Psychiatric disease
8. Pregnancy

Recruitment start date

01/02/2003

Recruitment end date

01/12/2005

Locations

Countries of recruitment

Brazil

Trial participating centre

Federal University of Sao Paulo
Sao Paulo
04023-062
Brazil

Sponsor information

Organisation

Coordination of Improvement of Higher Education (Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior [CAPES]) (Brazil)

Sponsor details

Ministério da Educação
Anexos I e II - 2º andar
DF - Caixa Postal 365
Brasilia
70359-970
Brazil
dfreitas@uol.com.br

Sponsor type

Government

Website

http://www.capes.gov.br

Funders

Funder type

Government

Funder name

Coordination of Improvement of Higher Education (Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior [CAPES]) (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

Publication citations

Additional files

Editorial Notes