Assessing the efficacy and safety of a recently introduced type of surgical device (Preserflo Microshunt) in the treatment of glaucoma
| ISRCTN | ISRCTN96192007 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96192007 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Centro Hospitalar Lisboa Norte |
| Funder | Universidade de Lisboa |
- Submission date
- 19/09/2021
- Registration date
- 11/10/2021
- Last edited
- 11/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Glaucoma is a common eye disease affecting the optic nerve and leading to irreversible blindness. This disease is thought to be caused by excess pressure inside the eye. The Preserflo Microshunt is a device similar to a tube that is implanted in the front part of the eye and allows for the drainage of fluid from the eye, relieving the pressure. The aim of this study is to determine how effective is this surgery, if it effectively lowers the pressure in the long term, if it relieves the burden of eye drops in glaucoma patients, and if it is a safe surgical option.
Who can participate?
Data is extracted from patient files of any adult patient with glaucoma who has been implanted with the Preserflo Microshunt between June 2019 and September 2021 at the Hospital de Santa Maria, Centro Hospitalar e Universitário Lisboa Norte
What does the study involve?
The investigators will examine the patient charts to analyze if the surgery effectively reduced eye pressure in a safe manner throughout the patients' follow-up time.
What are the possible benefits and risks of participating?
None as this is a retrospective study
Where is the study run from?
Hospital de Santa Maria, Centro Hospitalar e Universitário Lisboa Norte (Portugal)
When is the study starting and how long is it expected to run for?
May 2019 to December 2021
Who is funding the study?
Universidade de Lisboa (Portugal)
Who is the main contact?
Rafael Barão
rafaelcbarao@gmail.com
Contact information
Scientific
Av. Prof. Egas Moniz
Lisbon
1649-035
Portugal
 ORCID ID |
0000-0002-3102-1969 |
|---|---|
| Phone | +351 (0)916316796 |
| rafael.barao@chln.min-saude.pt |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-center cross sectional observational study |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| Scientific title | Early clinical outcomes of the Preserflo Microshunt |
| Study objectives | To assess the efficacy (hypotensive power) and safety (rate of complications) of the Preserflo Microshunt, an aqueous drainage shunt aimed for the treatment of medically uncontrolled glaucoma. |
| Ethics approval(s) | Approval pending, North Lisbon University Hospital (CHUL) and Lisbon Academic Center (CAML) Ethics Committee (Av. Prof. Egas Moniz, 1649-035 Lisboa; +351 (0)217805405; anapimentel@chln.min-saude.pt) |
| Health condition(s) or problem(s) studied | Intraocular pressure control in patients with glaucoma |
| Intervention | Data is extracted from patient files (background history, glaucoma characteristics, baseline intraocular pressure [IOP], preoperative visual acuity [VA], number of ocular hypotensive medication, intra-operative and postoperative complications, follow-up from visits on day 1; at weeks 1, 4; at months 3, 6 and 12 after Preserflo Microshunt implantation; number of postoperative IOP-lowering medication at all timepoints; and previous or subsequent surgical interventions). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
The surgical success of Preserflo Microshunt implantation at 12 months postoperative, defined as at least 30% reduction in IOP from baseline and final IOP ≤18mmHg and >5 mmHg, with (qualified success) or without hypotensive drugs (absolute success) |
| Key secondary outcome measure(s) |
1. Mean IOP in mmHg measured using Goldmann applanation tonometry and retrieved from patient files at the last pre-operative visit and at day 1, day 7, months 1, 3, 6, 12, 18 and 24 postoperative (when respectively applicable) |
| Completion date | 01/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | 1. Patients submitted to Preserflo Microshunt implantation for medically uncontrolled glaucoma between June 2019 and September 2021 2. Age ≥18 years and have agreed to chart review as per GDPR regulations |
| Key exclusion criteria | 1. Pregnancy or breastfeeding 2. Severe cardiovascular disease (including a stroke or a myocardial infarction 6 months before) 3. Known allergic reaction to MMC |
| Date of first enrolment | 01/06/2019 |
| Date of final enrolment | 30/09/2021 |
Locations
Countries of recruitment
- Portugal
Study participating centre
Lisbon
1649-035
Portugal
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from any investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose, exclusively for individual participant data meta-analysis. Data requests should be addressed to Rafael Barão (rafael.barao@chln.min-saude.pt). Data willing to be shared will include relevant individual participant data that underlie the results reported in this article, after deidentification and anonymisation. Data requests may be submitted from 6 months to up to 24 months following article publication. Use of this data has been included in the patient consent form. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
11/10/2021: Trial's existence confirmed by North Lisbon University Hospital.
