Elsevier

Ophthalmology Glaucoma

Volume 6, Issue 4, July–August 2023, Pages 342-357
Ophthalmology Glaucoma

Original Article
Clinical Outcomes and Cost Analysis of PreserFlo versus Trabeculectomy for Glaucoma Management in the United Kingdom

https://doi.org/10.1016/j.ogla.2022.11.006Get rights and content
Under a Creative Commons license
open access

Purpose

Clinical evaluation and cost analysis of mitomycin-C–augmented PreserFlo MicroShunt versus trabeculectomy.

Design

Retrospective cohort study across 3 teaching hospitals.

Participants

A total of 134 consecutive eyes of 129 patients (70 undergoing MicroShunt, 64 trabeculectomy).

Methods

Primary and secondary glaucoma cases with uncontrolled intraocular pressure (IOP) were included. Neovascular glaucoma and surgery combined with cataract extraction were excluded. The cost analysis used results from the clinical study to estimate operative costs (equipment and staff costs) and postoperative costs (follow-up visits, nonglaucoma medications, and postoperative procedures) per eye for PreserFlo and trabeculectomy.

Main Outcome Measures

The primary clinical outcome measure was surgical failure (defined as IOP > 21 mmHg or < 20% reduction from baseline, IOP ≤ 5 mmHg, reoperation, or loss of light perception) or qualified and complete success (with or without medication) at 18 months. Secondary measures were IOP, glaucoma medications, visual acuity, mean deviation, time to cessation of steroid drops, complications, surgical time, follow-up visits, postoperative interventions, and reoperations. The cost analysis evaluated costs of PreserFlo compared with trabeculectomy.

Results

Baseline characteristics were similar, except for more non-White patients in the trabeculectomy group (51% Black and Asian vs. 32% MicroShunt, P = 0.02) and more cases with prior ab externo glaucoma surgery in the MicroShunt group (19% vs. 3% in the trabeculectomy group, P = 0.004). Overall, 59% of eyes had primary open-angle glaucoma. Mean follow-up was 19.9 months for both groups. At 18 months, surgical failure was 25% for MicroShunt compared with 35% for trabeculectomy (P = 0.18). Failure in MicroShunt cases was due to inadequate IOP reduction (84%) or reoperation for glaucoma (16%). Failure in trabeculectomy cases was due to inadequate IOP reduction (58%), persistent hypotony (29%), or reoperation for glaucoma (13%). Combined blebitis and endophthalmitis rate was 1.4% for MicroShunt and 3.1% for trabeculectomy. Cost analysis showed a savings of £245 to £566 per eye in the MicroShunt group, driven mostly by reduced postoperative procedures and follow-up visits. This is in contrast to prior randomized controlled trial data reporting the incremental cost of $2058 of PreserFlo over trabeculectomy.

Conclusions

Our experience of introducing PreserFlo MicroShunt surgery showed it was safer than trabeculectomy and is a cost-saving and effective option that offers potential to free up highly limited National Health Service resources.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found after the references.

Keywords

Cost analysis, Glaucoma, Health economics, PreserFlo MicroShunt, Trabeculectomy

Abbreviations and Acronyms

AC
anterior chamber
BAME
Black, Asian, or minority ethnic
BRE
bleb-related endophthalmitis
CI
confidence interval
CS
complete success
dB
decibel
5FU
5-fluorouracil
HR
hazard ratio
IOP
intraocular pressure
MMC
mitomycin-C
NHS
National Health Service
QS
qualified success
RCT
randomized controlled trial
VA
visual acuity

Cited by (0)

Supplemental material available at www.ophthalmologyglaucoma.org.

Interim results of this study were presented at the International Congress on Glaucoma Surgery (2020), European Glaucoma Society Congress (2020), and the UK Eire Glaucoma Society Conference (2022).

Disclosure(s):

All authors have completed and submitted the ICMJE disclosures form.

The authors made the following disclosures:

I.R.: Consulting fees – iSTAR Medical, TTP (The Technology Partnership); Lecture fees – Santen; Travel expenses – iSTAR Medical, The Apperta Foundation; Advisory board member – Altacor; Committee member – NICE (National Institute for Health and Care excellence) glaucoma guideline update committee.

G.L.: Financial support – AbbVie, Aerie; Leadership – Deputy Chair, NAMinG Trial Management Committee/Group; Services – Glaukos, Rayner.

C.B.: Lecture fees – Santen.

E.C.: Consulting fees – Santen.

K.S.L.: Consultanting fees – Santen; Lecture fees – Santen.

SL: Lecture fees – Santen.

HUMAN SUBJECTS: Human subjects were included in this study. This study adhered to the tenets of the Declaration of Helsinki. A Health Research Authority decision tool deemed ethical approval was not required and the study was registered as an audit at each hospital trust (STH 10536, KCH GL001)

No animal subjects were used in this study.

Author Contributions:

Conception and design: Van Lancker, Abu-Bakra, Barwood, Combe, Kulkarni, Lim, Low

Analysis and interpretation: Van Lancker, Barwood, Combe, Lim, Low

Data collection: Van Lancker, Saravanan, Reid, Quijano, Low

Obtained funding: N/A

Overall responsibility: Van Lancker, Saravanan, Abu-Bakra, Reid, Quijano, Goyal, Rodrigues, Lascaratos, Trikha, Barwood, Combe, Kulkarni, Lim, Low