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One-year surgical outcomes of the PreserFlo MicroShunt in glaucoma: a multicentre analysis
Alexander Tanner1,2, Fadi Haddad3, Julia Fajardo-Sanchez1,2
1Faculty of Life Sciences & Medicine, King's College London, London, UK.
Background/Aims:
To evaluate the efficacy and safety of the PreserFlo MicroShunt glaucoma device in a multicentre cohort study.
Methods:
All consecutive patients who received the microshunt with mitomycin-C (MMC) 0.4 mg/mL from May 2019 to September 2020 in three UK tertiary centres. Primary outcome at 1 year was a complete success, with failure defined as intraocular pressure (IOP) >21 mmHg or <20% reduction, IOP≤5 mmHg with any decreased vision on two consecutive visits, reoperation or loss of light perception vision. Secondary outcomes were IOP, best-corrected visual acuity, medications, complications, interventions and reoperations. We also performed subgroup analyses for severe glaucoma and assessed risk factors for failure.
Results:
104 eyes had 1-year follow-up. Complete and qualified success at 1 year were achieved in 51.9% (N=54) and 16.4% (N=17), respectively, and failure occurred in 31.7% (N=33). There was a significant reduction in IOP (mmHg) from preoperatively (23.4±0.8, N=104) to 12 months (14.7±0.6, N=104) (p<0.0001). Antiglaucoma medications also decreased from preoperatively (3.4±0.1, N=104) to 12 months (0.7±0.1, N=104) (p<0.0001). Multivariate analyses showed an association between higher mean deviation and failure (HR 1.055, 95% CI 1.0075 to 1.11, p=0.0227). Complications were hypotony (19.2%; N=20), choroidal detachments (10.6%; N=11), hyphaema (5.8%; N=6) and bleb leak (5.8%; N=6). Needling and 5-fluorouracil injections were performed in 12.5% (N=13) and 33.7% (N=35), respectively, and 11.5% (N=12) required revision surgery.
Conclusion:
The PreserFlo MicroShunt with MMC 0.4 mg/mL showed an overall success rate of 68.3% at 1 year, and led to significant IOP and medication reduction with a low rate of adverse effects.
Insights
The PreserFlo MicroShunt demonstrated a 68.3% success rate in glaucoma patients after one year, significantly reducing intraocular pressure and medication needs with few adverse effects.
Area of Science:
- Ophthalmology
- Glaucoma Surgery
- Medical Devices
Background:
- Glaucoma management requires effective treatments to lower intraocular pressure (IOP).
- The PreserFlo MicroShunt is a device used in glaucoma surgery.
- Mitomycin-C (MMC) is often used adjunctively in glaucoma procedures.
Purpose of the Study:
- To evaluate the efficacy and safety of the PreserFlo MicroShunt device in a multicentre cohort study.
- To assess the 1-year outcomes of PreserFlo MicroShunt implantation with mitomycin-C (MMC).
Main Methods:
- A multicentre cohort study included patients receiving the PreserFlo MicroShunt with MMC 0.4 mg/mL.
- Primary outcome was complete success at 1 year, defined by specific IOP and vision criteria.
- Secondary outcomes included IOP, visual acuity, medication use, complications, and reoperations.
Main Results:
- 104 eyes completed 1-year follow-up.
- Overall success rate was 68.3% (51.9% complete, 16.4% qualified).
- Significant reductions in IOP (23.4 to 14.7 mmHg) and medications (3.4 to 0.7) were observed (p<0.0001).
- Complications included hypotony (19.2%) and choroidal detachments (10.6%).
- Higher mean deviation was associated with failure (HR 1.055, p=0.0227).
Conclusions:
- The PreserFlo MicroShunt with MMC 0.4 mg/mL achieved a 68.3% success rate at 1 year.
- The device significantly reduced IOP and medication requirements.
- Adverse effects were generally low, indicating a favorable safety profile.
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