Evidence map›Paper›PMID 39741793›Full record

Trial reportClinical ophthalmology (Auckland, N.Z.)2024

Safety and Efficacy of STREAMLINE Canaloplasty with Phacoemulsification in Hispanic Adults with Open-Angle Glaucoma: 12-Month Outcomes.

Gabriel Lazcano-Gomez, Claudio Orlich, Juan F Batlle, Elysia M Ison, Heather P Reynolds, Med Harbin, Malik Y Kahook

Abstract readCase ReportsClinical Trial
In one paragraph

Trial report in Clinical ophthalmology (Auckland, N.Z.), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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

7 authors.

Gabriel Lazcano-GomezDepartment of Glaucoma, Clínica Laser y Ultrasonido Ocular, Puebla City, Mexico.ORCID 0000-0003-4818-9343
Claudio OrlichClinica 20/20, San José, Costa Rica.
Juan F BatlleLaser Center, Santo Domingo, Dominican Republic.ORCID 0000-0003-3403-069X
Elysia M IsonNew World Medical, Inc., Rancho Cucamonga, CA, USA.
Heather P ReynoldsNew World Medical, Inc., Rancho Cucamonga, CA, USA.
Med HarbinNew World Medical, Inc., Rancho Cucamonga, CA, USA.ORCID 0009-0003-2047-0333
Malik Y KahookDepartment of Ophthalmology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: To report the 12-month clinical outcomes in eyes with mild to moderate open-angle glaucoma (OAG) in Hispanic adults undergoing STREAMLINE Surgical System (STREAMLINE) canaloplasty combined with phacoemulsification. Patients and Methods: This was a prospective, multi-center, interventional clinical trial involving 45 eyes of 45 Hispanic adult patients receiving topical medical therapy for mild to moderate OAG and undergoing phacoemulsification surgery for visually significant cataracts at three sites. All eyes underwent a Screening visit, followed by medication washout and a subsequent Baseline visit to determine eligibility for STREAMLINE canaloplasty. The primary outcome was the proportion of unmedicated eyes with intraocular pressure (IOP) reduction of ≥20% from Baseline at Month 12. Secondary outcomes included mean change in IOP from post-washout Baseline, mean change in IOP-lowering medications compared to pre-washout Screening, and adverse events (AEs). Results: 43 eyes met the eligibility criteria for analysis and 40 eyes completed the 12-month visit. The mean (standard deviation) age was 68.7 (8.6 years), 76.7% were female, and 72.1% of the eyes were classified as having mild OAG. The mean number of IOP-lowering medications at Screening was 1.95 (0.82). After washout, the Baseline mean IOP was 23.0 (1.8) mmHg. At Month 12, 28/40 eyes (70.0%) remained medication-free, of which 27 (96.4%) had an IOP reduction of ≥20% from Baseline. The mean IOP at Month 12 was 15.3 (2.8) mmHg, a reduction of 7.8 (3.0) mmHg from Baseline (p<0.001). The mean medication use at Month 12 was 0.63 (1.19) per eye, representing a mean reduction of 1.38 (1.03) medications from Screening (p<0.001). Device- or procedure-related ocular AEs were mostly mild in severity and self-limited. Conclusion: STREAMLINE canaloplasty in combination with phacoemulsification provides clinically and statistically significant reduction in IOP and IOP-lowering medications in eyes with mild to moderate OAG in Hispanic adults.

Indexed as

canaloplastyintraocular pressureminimally invasive glaucoma surgeryopen-angle glaucomaSTREAMLINE Surgical System

Identifiers

PMID39741793
PMCPMC11687135

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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.