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Pooled Analysis of Three MicroShunt Studies in Primary Open-Angle Glaucoma Evaluating Different Concentrations of
Julián Garcia-Feijoo1, Juan F Batlle2, Florent Aptel3
1Departamento de Oftalmologia, Universidad Complutense, Hospital Clínico San Carlos, OFTARED, IdISSC, Planta 3, Madrid, Spain. jgarciafeijoo@hotmail.com.
Introduction:
The PRESERFLO MicroShunt is an 8.5-mm-long (70-µm lumen) controlled ab externo filtration surgery device made from poly[styrene-block-isobutylene-block-styrene] (SIBS). Three prospective, open-label clinical trials (ClinicalTrials.gov Identifiers: NCT00772330; NCT01563237; NCT02177123) evaluated the 2-year effectiveness and safety of MicroShunt implantation plus mitomycin C (MMC). This pooled analysis compared outcomes in patients receiving 0.2 or 0.4 mg/ml MMC during MicroShunt implantation.
Methods:
Patients aged 18-85 years with primary open-angle glaucoma (intraocular pressure [IOP] 18-35 mmHg) uncontrolled on maximal tolerated medical therapy and/or where glaucoma progression warranted surgery who underwent MicroShunt implantation with/without cataract surgery, and with adjunctive use of 0.2 or 0.4 mg/ml MMC. Two-year outcomes included changes in IOP and glaucoma medications, complete success rates (IOP ≥ 6 to < 14 mmHg or ≥ 20% reduction, without medications), and rates of procedure/device-related adverse events (AEs) and serious AEs (SAEs).
Results:
Of the 125 included patients, 58 received 0.2 mg/ml MMC and 67 received 0.4 mg/ml MMC). Mean percent reduction in IOP was significantly greater in patients receiving 0.4 than 0.2 mg/ml MMC (- 40.9% vs. - 34.5%, P < 0.05). Mean glaucoma medication use was reduced to a lower level between baseline and year 2 in the 0.4 than in the 0.2 mg/ml MMC group. At year 2, the percentage of medication-free patients (85.2% vs. 58.0%, P < 0.01) and the complete success rates (71.6% vs. 48.3%, P < 0.01) were significantly higher in the 0.4 than in the 0.2 mg/ml MMC group. Rates of procedure/device-related AEs and SAEs did not differ significantly in the two groups (P > 0.05).
Conclusions:
IOP and glaucoma medication use at year 2 were lower, and complete success rate was higher, in patients administered 0.4 mg/ml than 0.2 mg/ml MMC. Although there is no consensus on the optimal concentration of MMC, these findings may guide surgeons until further evidence from controlled trials becomes available.
Insights
Higher concentrations of mitomycin C (MMC) during PRESERFLO MicroShunt surgery led to better outcomes for glaucoma patients. The 0.4 mg/ml MMC group showed greater intraocular pressure reduction and higher success rates compared to the 0.2 mg/ml group.
Area of Science:
- Ophthalmology
- Glaucoma Surgery
- Surgical Devices
Background:
- The PRESERFLO MicroShunt is a poly[styrene-block-isobutylene-block-styrene] (SIBS) device for ab externo filtration surgery.
- Previous trials evaluated the 2-year effectiveness and safety of MicroShunt implantation with mitomycin C (MMC).
- This pooled analysis compares outcomes using two different MMC concentrations (0.2 mg/ml vs. 0.4 mg/ml).
Purpose of the Study:
- To compare the 2-year effectiveness and safety of PRESERFLO MicroShunt implantation using 0.2 mg/ml versus 0.4 mg/ml mitomycin C (MMC).
- To evaluate the impact of different MMC concentrations on intraocular pressure (IOP) and glaucoma medication use.
- To assess complete success rates and adverse events associated with varying MMC concentrations.
Main Methods:
- Pooled analysis of three prospective, open-label clinical trials (NCT00772330, NCT01563237, NCT02177123).
- Included 125 patients aged 18-85 with primary open-angle glaucoma uncontrolled on maximal medical therapy.
- Patients received MicroShunt implantation with either 0.2 mg/ml (n=58) or 0.4 mg/ml (n=67) MMC, with 2-year outcome assessment.
Main Results:
- Greater mean IOP reduction was observed with 0.4 mg/ml MMC (-40.9%) compared to 0.2 mg/ml MMC (-34.5%) (P<0.05).
- Significantly higher rates of medication-free patients (85.2% vs. 58.0%, P<0.01) and complete success (71.6% vs. 48.3%, P<0.01) at 2 years in the 0.4 mg/ml group.
- No significant difference in procedure/device-related adverse events or serious adverse events between the two MMC concentration groups.
Conclusions:
- Higher concentration of mitomycin C (0.4 mg/ml) resulted in lower 2-year IOP and glaucoma medication use compared to 0.2 mg/ml.
- The 0.4 mg/ml MMC group demonstrated a significantly higher complete success rate at 2 years post-MicroShunt implantation.
- Findings suggest 0.4 mg/ml MMC may be more effective, guiding surgical choices pending further controlled trial data.
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