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Peer-reviewedCC BY 4.0Journal of Glaucoma

Evaluating Long-Term Effectiveness and Safety of Glaucoma Surgical Innovations: A Systematic Review

  1. 1Centre of Public Health, Institute of Clinical Science, Queen’s University Belfast, Belfast, UK
  2. 2Eye Clinic, Neuromuscular and Sense Organs Department, Careggi University Hospital, Florence, Italy

Abstract

Précis:: A systematic review examining the reporting of long-term safety of glaucoma surgical innovations. Twenty-seven studies met the inclusion criteria and demonstrated effectiveness over the short to medium term. Use of registries to optimise future long-term evaluation is recommended.

Purpose:: To synthesise evidence on the long-term effectiveness and safety of glaucoma surgical innovations introduced since 2004 and appraise reporting quality against IDEAL Stage 4 recommendations, designed to promote transparent study of the long-term impact of surgical innovations.

Methods:: MEDLINE, EMBASE, and CENTRAL were searched for studies published from January 1, 2014, to October 21, 2024. Eligible studies evaluated novel glaucoma surgery with ≥2 years’ follow-up and ≥100 participants. Randomised controlled trials, observational studies, registry analyses, and case series were included. Reporting was assessed using a 16-item adaptation of the IDEAL Stage 4 checklist. Risk of bias was assessed using Cochrane RoB 2, the Newcastle-Ottawa Scale, and the Joanna Briggs Institute case-series checklist.

Results:: The search strategy retrieved 1758 matches, with 27 studies meeting the inclusion criteria. Procedures included iStent, Xen-45 Gel stent, Hydrus microstent, Endoscopic photocoagulation, Trabectome and Kahook dual blade. Follow-up ranged from 2 to 6 years. All studies described design and 22 reported prespecified outcomes sufficiently; however, only 4 explained how missing data were handled. Intraocular-pressure and medication outcomes generally favoured the intervention, but heterogeneity in design, comparators, outcomes, and surgical context precluded pooled estimates. Adverse-event reporting was inconsistent. One cohort study was of poor quality; 14 case series had unclear or unreported methodological items; and 4 RCTs had at least one high-risk domain.

Conclusions:: Glaucoma surgical innovations appear effective over the medium term, but limited long-term follow-up and inconsistent safety reporting preclude firm conclusions about comparative effectiveness and long-term safety. Standardised reporting and prospective registries are needed.

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BibTeX
@article{ashok2026evaluating,
  title = {{Evaluating Long-Term Effectiveness and Safety of Glaucoma Surgical Innovations: A Systematic Review}},
  author = {Sanjana Ashok and Chiara De Vitto and Philip McCullough and Laura Luchetti and Anna Mengozzi and Augusto Azuara-Blanco},
  journal = {Journal of Glaucoma},
  year = {2026},
  month = oct,
  doi = {10.1097/ijg.0000000000002770},
  url = {https://doi.org/10.1097/ijg.0000000000002770},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Evaluating Long-Term Effectiveness and Safety of Glaucoma Surgical Innovations: A Systematic Review
AU  - Sanjana Ashok
AU  - Chiara De Vitto
AU  - Philip McCullough
AU  - Laura Luchetti
AU  - Anna Mengozzi
AU  - Augusto Azuara-Blanco
PY  - 2026
DA  - 2026/10/16
JO  - Journal of Glaucoma
DO  - 10.1097/ijg.0000000000002770
UR  - https://doi.org/10.1097/ijg.0000000000002770
AB  - Précis:: A systematic review examining the reporting of long-term safety of glaucoma surgical innovations. Twenty-seven studies met the inclusion criteria and demonstrated effectiveness over the short to medium term. Use of registries to optimise future long-term evaluation is recommended.  Purpose:: To synthesise evidence on the long-term effectiveness and safety of glaucoma surgical innovations introduced since 2004 and appraise reporting quality against IDEAL Stage 4 recommendations, designed to promote transparent study of the long-term impact of surgical innovations.  Methods:: MEDLINE, EMBASE, and CENTRAL were searched for studies published from January 1, 2014, to October 21, 2024. Eligible studies evaluated novel glaucoma surgery with ≥2 years’ follow-up and ≥100 participants. Randomised controlled trials, observational studies, registry analyses, and case series were included. Reporting was assessed using a 16-item adaptation of the IDEAL Stage 4 checklist. Risk of bias was assessed using Cochrane RoB 2, the Newcastle-Ottawa Scale, and the Joanna Briggs Institute case-series checklist.  Results:: The search strategy retrieved 1758 matches, with 27 studies meeting the inclusion criteria. Procedures included iStent, Xen-45 Gel stent, Hydrus microstent, Endoscopic photocoagulation, Trabectome and Kahook dual blade. Follow-up ranged from 2 to 6 years. All studies described design and 22 reported prespecified outcomes sufficiently; however, only 4 explained how missing data were handled. Intraocular-pressure and medication outcomes generally favoured the intervention, but heterogeneity in design, comparators, outcomes, and surgical context precluded pooled estimates. Adverse-event reporting was inconsistent. One cohort study was of poor quality; 14 case series had unclear or unreported methodological items; and 4 RCTs had at least one high-risk domain.  Conclusions:: Glaucoma surgical innovations appear effective over the medium term, but limited long-term follow-up and inconsistent safety reporting preclude firm conclusions about comparative effectiveness and long-term safety. Standardised reporting and prospective registries are needed.
SN  - 1057-0829
SN  - 1536-481X
ER  -