Assessing the efficacy and safety of a recently introduced type of surgical device (Preserflo Microshunt) in the treatment of glaucoma

Early clinical outcomes of the Preserflo Microshunt

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN96192007

Enrollment

100

Registered

2021-10-11

Start date

2019-06-01

Completion date

Unknown

Last updated

2021-10-26

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

Conditions

Intraocular pressure control in patients with glaucoma Eye Diseases Glaucoma

Interventions

Data is extracted from patient files (background history, glaucoma characteristics, baseline intraocular pressure [IOP], preoperative visual acuity [VA], number of ocular hypotensive medication, intra

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).

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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)	—

Secondary

Measure	Time frame
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) 2. Mean number of hypotensive drugs 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) 3. Intra-operative or postoperative complications retrieved from patient files at time of surgery, day 1, day 7, months 1, 3, 6, 12, 18 and 24 (when respectively applicable)	—

Measure

Time frame

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) 2. Mean number of hypotensive drugs 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) 3. Intra-operative or postoperative complications retrieved from patient files at time of surgery, day 1, day 7, months 1, 3, 6, 12, 18 and 24 (when respectively applicable)

—

Countries

Portugal

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026