To analyze surgical success comparing a single medication (antifibrotic drug) with double medication (same antifibrotic plus antiproliferative drug) in trabeculectomy (filtrating surgery to decrease intraocular pressure in glaucoma patients)
| ISRCTN | ISRCTN93098069 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93098069 |
| Secondary identifying numbers | 20031992 |
- Submission date
- 07/04/2020
- Registration date
- 15/04/2020
- Last edited
- 05/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Glaucoma is a common eye condition where the optic nerve, which connects the eye to the brain, becomes damaged. It's usually caused by fluid building up in the front part of the eye, which increases pressure inside the eye.
Trabeculectomy is a surgical operation which lowers the intraocular pressure inside the eye (IOP) in patients with glaucoma. This is achieved by making a small hole in the eye wall (sclera).
Avoiding excessive wound healing response remains a problem, once surgery success depends on maintaining patency of the fistula and bleb filtration. Antiproliferative agents such as mitomycin C (MMC) reduce inflammation and scarring process, improving surgical outcome. However, besides the high risk of potentially complications, studies have not proven to be fully satisfactory and new therapeutic approaches more effective and safer are currently been used to augment surgery. The use of antiangiogenic factors (such as bevacizumab) has been associated with slowing this proliferative and fibrotic process after filtration surgery.
The study aims to explore this promising modality to understand if bevacizumab is an important additional agent in improving the prognosis of glaucoma filtrating surgery.
Who can participate?, What does the study involve?
Data is extracted from medical charts of patients submitted to primary trabeculectomy for open-angle glaucoma at Centro Hospitalar Universitário Lisboa Norte and Hospital dos Lusíadas between October 2015 and March 2019
What are the possible benefits and risks of participating?
None (retrospective study)
Where is the study run from?
1. Centro Hospitalar Universitário Lisboa Norte (Portugal)
2. Hospital dos Lusíadas (Portugal)
When is the study starting and how long is it expected to run for?
September 2019 to May 2020
Who is funding the study?
Centro de Estudos das Ciências da Visão - Faculdade de Medicina da Universidade de Lisboa
Who is the main contact?
Dr Patrícia José, patricialopes1@campus.ul.pt
Contact information
Public
Centro Hospitalar Universitário Lisboa Norte
Av. Prof. Egas Moniz
Lisbon
1649-035
Portugal
 ORCID ID |
0000-0002-4523-7306 |
|---|---|
| Phone | +351 964958859 |
| patricialopes1@campus.ul.pt |
Study information
| Study design | Observational cross-sectional cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | Trabeculectomy with mitomycin C or with mitomycin C plus intracameral bevacizumab injection? A comparative study |
| Study objectives | To analyze the benefits of using intracameral bevacizumab injection as an add on to the standard of care use of mitomycin C (MMC) in trabeculectomy. |
| Ethics approval(s) | Approved 17/12/2019, Ethics Committee of Centro Hospitalar Universitário Lisboa Norte and Hospital dos Lusíadas (R. Abílio Mendes, 1500-458, Lisbon, Portugal; +351 966 184 461; knowledgecenter@lusiadas.pt), ref: n/a |
| Health condition(s) or problem(s) studied | Trabeculectomy |
| Intervention | Data is extracted from medical charts (background history, glaucoma characteristics, baseline IOP, preoperative visual acuity, number of ocular hypotensive medication, safety parameters, follow-up from visits on day 1; at weeks 1, 4; at months 3, 6, 12 and 24 after trabeculectomy, number of postoperative IOP-lowering medication and surgical interventions). All consecutive patients from one site (Centro Hospitalar Universitário Lisboa Norte) received standard of care; all consecutive patients from the second site (Hospital dos Lusíadas) received the becavizumab as an add on to standard of care. Statistical analysis is carried out using SPSS software (Chicago, IL, version 24.0). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The absolute and qualified surgical success rate of trabeculectomy at 12 months and 24 months defined as intraocular pressure ≤18 mmHg and >5mmHg with at least 30% reduction in IOP from baseline |
| Secondary outcome measures | 1. Intra- and postoperative complications measured using patient records 2. Additional effects of bevacizumab measured using patient records |
| Overall study start date | 01/09/2019 |
| Completion date | 01/05/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Review of entire set of patients within the time range (128 patients assessed for study) |
| Total final enrolment | 128 |
| Key inclusion criteria | 1. Patients submitted to primary trabeculectomy for open-angle glaucoma between October 2015 and March 2019 2. No other previous surgeries, except uncomplicated phaco 3. ≥ 18 years and have agreed to chart review as per GDPR regulations |
| Key exclusion criteria | 1. Pregnancy or breastfeeding 2. Combination with cataract surgery 3. History of another eye disease 4. Uncontrolled blood pressure (systolic >180 mmHg and/or diastolic >100 mmHg while a patient is at rest) 5. Severe cardiovascular disease (including a stroke or a myocardial infarction 6 months before) 6. Known allergic reaction to bevacizumab or MMC |
| Date of first enrolment | 01/10/2015 |
| Date of final enrolment | 01/03/2019 |
Locations
Countries of recruitment
- Portugal
Study participating centres
Lisbon
1649-028
Portugal
Lisbon
1500-258
Portugal
Sponsor information
Hospital/treatment centre
Hospital Lusíadas
Av. Prof Egas Moniz
Lisbon
1649-028
Portugal
| Phone | +351 962958859 |
|---|---|
| patricialopes1@campus.ul.pt | |
| Website | http://www.chln.min-saude.pt/ |
"ROR" |
https://ror.org/020sr6z07 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- Universitas Olisiponensis, University of Lisbon, Technical University of Lisbon, ULisboa | Universidade de Lisboa, University of Lisbon, Portugal, New University of Lisbon (Portugal), ULisboa
- Location
- Portugal
Results and Publications
| Intention to publish date | 31/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | The results of this study should be published in a high-visibility peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 30/04/2021 | 05/05/2021 | Yes | No |
Editorial Notes
05/05/2021: Publication reference added.
09/04/2020: Trial’s existence confirmed by Hospital dos Lusíadas
