Use of prednisone for choroidal detachment after trabeculectomy

ISRCTN	ISRCTN15966680
DOI	https://doi.org/10.1186/ISRCTN15966680
Secondary identifying numbers	0745/02

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Augusto Paranhos
Scientific

Federal University of Sao Paulo
Botucatu, 824
Sao Paulo
04023-062
Brazil

Email	augusto.paranhos@uol.com.br

Study design	Double-masked randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Use of prednisone for choroidal detachment after trabeculectomy: a double-masked randomised controlled trial
Study objectives	To evaluate the treatment with oral prednisone for choroidal detachment after trabeculectomy.
Ethics approval(s)	The Ethics Committee of the Federal University of Sao Paulo gave approval on the 27th November 2002.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Prednisone
Primary outcome measure	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 study start date	01/02/2003
Completion date	01/12/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	40
Key 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
Key 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
Date of first enrolment	01/02/2003
Date of final enrolment	01/12/2005

Federal University of Sao Paulo

Sao Paulo
04023-062
Brazil

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

Ministério da Educação
Anexos I e II - 2º andar
DF - Caixa Postal 365
Brasilia
70359-970
Brazil

Government

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

No information available

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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