Use of prednisone for choroidal detachment after trabeculectomy
| ISRCTN | ISRCTN15966680 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15966680 |
| Protocol serial number | 0745/02 |
| Sponsor | Coordination of Improvement of Higher Education (Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior [CAPES]) (Brazil) |
| Funder | Coordination of Improvement of Higher Education (Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior [CAPES]) (Brazil) |
- Submission date
- 14/10/2008
- Registration date
- 30/10/2008
- Last edited
- 30/10/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
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
Contact information
Dr Augusto Paranhos
Scientific
Scientific
Federal University of Sao Paulo
Botucatu, 824
Sao Paulo
04023-062
Brazil
| augusto.paranhos@uol.com.br |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-masked randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Prednisone |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Intra-ocular pressure, evaluated every 5 days. |
| Completion date | 01/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Federal University of Sao Paulo
Sao Paulo
04023-062
Brazil
04023-062
Brazil
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
