Evidence map›Paper›PMID 40408035›Full record

ArticleOphthalmology and therapy2025

Pooled Analysis of Three MicroShunt Studies in Primary Open-Angle Glaucoma Evaluating Different Concentrations of Applied Mitomycin C.

Julián Garcia-Feijoo, Juan F Batlle, Florent Aptel, Yves Lachkar, Isabelle Riss, Omar Sadruddin, Tuan Nguyen, Henny J M Beckers

3 registry-linked trialsAbstract read
In one paragraph

Article in Ophthalmology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00772330 nacompletednot on this map

Clinical Study of the Safety and Performance of the Miami InnFocus Drainage Implant to Relieve Glaucoma Symptoms

TypeinterventionalSponsorInnFocus Inc.Ran2007 to 2017Enrolled23ConditionsGlaucomaArmsGlaucoma Drainage Device
NCT01563237 nacompletednot on this map

Safety and Performance of Miami InnFocus Drainage Implant (MIDI Arrow) to Relieve Glaucoma Symptoms

TypeinterventionalSponsorInnFocus Inc.Ran2011 to 2017Enrolled69ConditionsPrimary Open Angle GlaucomaArmsMIDI Arrow
NCT02177123 nacompletednot on this map

Post Market Study to Evaluate Safety and Effectiveness of the InnFocus Microshunt™ (MIDI Arrow) in Patients With Primary Open Angle Glaucoma

TypeinterventionalSponsorInnFocus Inc.Ran2014 to 2017Enrolled107ConditionsPrimary Open Angle GlaucomaArmsInnFocus MicroShunt implantation
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Functional assessment of the Preserflo MicroShunt implant in pigmentary glaucoma: 2 years follow-up.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026
    Observational
  5. Efficacy and Safety of the PreserfloJournal of clinical medicine · 2026
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Julián Garcia-FeijooDepartamento de Oftalmologia, Universidad Complutense, Hospital Clínico San Carlos, OFTARED, IdISSC, Planta 3, Madrid, Spain. jgarciafeijoo@hotmail.com.
Juan F BatlleCentro Láser, Santo Domingo, Dominican Republic.
Florent AptelGroupe Visis et médipôle Elsan, Perpignan, France.
Yves LachkarHôpital Paris Saint Joseph, Paris, France.
Isabelle RissPôle Ophtalmologique de la Clinique Mutualiste, Bordeaux, France.
Omar SadruddinSanten Pharmaceuticals, Emeryville, CA, USA.
Tuan NguyenSanten Pharmaceuticals, Emeryville, CA, USA.
Henny J M BeckersUniversity Eye Clinic, Maastricht University Medical Center, Maastricht, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe 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.

methodsPatients 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).

resultsOf 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).

conclusionsIOP 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.

Indexed as

Antifibrotic agentsGlaucoma filtration surgeryMicroShuntMMCPrimary open-angle glaucomaSIBS

Identifiers

PMID40408035
PMCPMC12167400

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.