Evidence map›Paper›PMID 41621045›Full record

ArticleOphthalmology and therapy2026

Prospective Pilot Study of Sustained Release Bimatoprost Implant with SpyGlass Intraocular Lens: 3-Year Results.

Nicholas E Tan, Gregory Katz, Marco Robles, Preeya K Gupta, Malik Y Kahook, Glenn Sussman, Paul Yoo, Nathan M Radcliffe

2 registry-linked trialsAbstract read
In one paragraph

Article in Ophthalmology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.

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

NCT07154797 nacompletednot on this map

A Prospective Trial to Evaluate the Safety and Effectiveness of the Sustained Release Bimatoprost Implant With SpyGlass IOL in Patients With Ocular Hypertension or Mild to Moderate Open-Angle Glaucoma

TypeinterventionalSponsorSpyGlass Pharma, Inc.Ran2022 to 2022Enrolled24ConditionsCataract, Ocular Hypertension, GlaucomaArmsBimatoprost Implant System / IOL Combination
NCT07154810 active not recruitingnot on this map

Observational Study to Evaluate Long-term Follow-up of Subjects Implanted With Sustained-release Bimatoprost With the SpyGlass IOL in Subjects With Ocular Hypertension or Mild-to-moderate Open-angle Glaucoma

TypeobservationalSponsorSpyGlass Pharma, Inc.Ran2023 to 2031Enrolled23ConditionsGlaucoma, Cataract, Ocular Hypertension
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Nicholas E TanDepartment of Ophthalmology, University of Colorado School of Medicine, Aurora, CO, 80045, USA.ORCID http://orcid.org/0000-0002-7362-0038
Gregory KatzHuron Ophthalmology, Ypsilanti, MI, USA.
Marco RoblesCentro Oftalmologico Robles, Santa Rosa de Copan, Honduras.
Preeya K GuptaTriangle Eye Consultants, Raleigh, NC, USA.
Malik Y KahookDepartment of Ophthalmology, University of Colorado School of Medicine, Aurora, CO, 80045, USA.
Glenn SussmanSpyGlass Pharma, Inc., Aliso Viejo, CA, USA.
Paul YooSpyGlass Pharma, Inc., Aliso Viejo, CA, USA. paul.yoo@spyglasspharma.com.
Nathan M RadcliffeDepartment of Ophthalmology, Mount Sinai School of Medicine, New York, NY, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis study aimed to explore the safety and efficacy of sustained release bimatoprost implant with SpyGlass intraocular lens (SpyGlass Pharma, Inc., Aliso Viejo, CA, USA).

methodsTwenty-four subjects diagnosed with cataracts and mild-to-moderate primary open-angle glaucoma were consented at a single site in Honduras. Those with pathologies that could confound outcomes were excluded. All subjects were required to have responded to topical prostaglandin analogues. Medication washout was performed prior to intervention. One eye of each subject was sequentially assigned to one of three arms (75 μg, 150 μg, or 300 μg of bimatoprost pads). The product was delivered in-the-bag via a commercially available intraocular lens (IOL) inserter and did not modify the steps of standard phacoemulsification cataract surgery other than attachment of bimatoprost implants to the IOL. We report interim results through 36 months.

resultsTwenty-one of 24 enrollees (87.5%) were retained through 36 months. Through 24 months, all subjects achieved the primary endpoint of intraocular pressure (IOP) reduction > 20% from baseline without any additional glaucoma medications. By month 36, all but a single subject (95.2%, n = 20) remained drop-free with continued IOP reductions > 20% across all remaining subjects. Each treatment arm realized mean IOP reductions from 32.3% to 49.3% over 3 years of follow-up visits. There were no significant intergroup differences. All eyes had a final best-corrected distance visual acuity of 20/30 or better. There were no serious implant-related adverse events. The most common events were dry eye (21.7%), transient vision decrease (13.0%), and subconjunctival hemorrhage (8.7%). All implants remained in the capsular bag.

conclusionsThe first human study of a novel system that mounts bimatoprost-infused pads to a single-piece IOL suggests favorable safety and efficacy and does not require additional surgical skills beyond routine cataract surgery. A larger sample with comparative data is necessary to further assess effects.

trial registrationClinicalTrials.gov identifiers, NCT07154797 and NCT07154810. Retrospectively registered on September 3, 2025.

Indexed as

Cataract surgeryGlaucomaMIGSOcular hypertensionProstaglandin

Identifiers

PMID41621045
PMCPMC12901787

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.