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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)

Trabeculectomy with mitomycin C or with mitomycin C plus intracameral bevacizumab injection? A comparative study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN93098069
Enrollment
128
Registered
2020-04-15
Start date
2015-10-01
Completion date
Unknown
Last updated
2021-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trabeculectomy Surgery

Interventions

Data is extracted from medical charts (background history, glaucoma characteristics, baseline IOP, preoperative visual acuity, number of ocular hypotensive medication, safety parameters, follow-up fro
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 Lis
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, v

Sponsors

Centro Hospitalar Lisboa Norte
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. Intra- and postoperative complications measured using patient records 2. Additional effects of bevacizumab measured using patient records

Countries

Portugal

Contacts

Public ContactPatrícia José
patricialopes1@campus.ul.pt+351 964958859

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 16, 2026