Reporting Harm in Glaucoma Surgical Trials: Systematic Review and a Consensus-Derived New Classification System

Sii, Samantha; Barton, Keith; Pasquale, Louis R.; Yamamoto, Tetsuya; King, Anthony J; Azuara‐Blanco, Augusto

doi:10.1016/j.ajo.2018.07.014

Cited by 23 publications

(18 citation statements)

References 73 publications

(51 reference statements)

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“…24 25 In our study, the marked reduction of IOP and number of medications was statistically significant at all postoperative time points. There were no major complications 26 in any patient, and the combination of cataract surgery and GATT maintained the same effectiveness as GATT alone in pseudophakic patients. In 6 out of 103 eyes, a complete 360-degree trabeculotomy was not achieved; however, all these partial cases were successful.…”

Section: Discussionmentioning

confidence: 67%

Outcomes of gonioscopy-assisted transluminal trabeculotomy in pseudoexfoliative glaucoma: 24-month follow-up

Sharkawi¹,

Lindegger

Artes

et al. 2020

Br J Ophthalmol

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AimTo report on outcomes of gonioscopy-assisted transluminal trabeculotomy (GATT) in eyes with pseudoexfoliative glaucoma (PXG).MethodsProspective, interventional, non-comparative case series. A total of 103 eyes from 84 patients with PXG were enrolled to undergo a 360-degree ab interno trabeculotomy with gonioscopic assistance using either a 5.0 polypropylene suture or an illuminated microcatheter with up to 24 months of follow-up. Main outcome measures were intraocular pressure (IOP), number of antiglaucoma medications, success rate (IOP reduction ≥20% from baseline or IOP between 6 and 21 mm Hg, without further glaucoma surgery) and complication rate.ResultsMean preoperative IOP was 27.1 mm Hg (95% CI 25.5 to 28.7) using 2.9 (SD 1.1) glaucoma medications which decreased postoperatively to 13.0 mm Hg (95% CI 11.5 to 14.4) and 1.0 (SD 1.1) medications at 24 months (p<0.001). Success rate was 89.2% at 24 months of follow-up, and complication rate was 2.9%.ConclusionAt 24 months of follow-up, our results for GATT in PXG demonstrate that this conjunctival sparing procedure effectively lowers IOP and reduces the medications with a low complication rate, in this relatively aggressive glaucoma subtype.

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Section: Discussionmentioning

confidence: 67%

Outcomes of gonioscopy-assisted transluminal trabeculotomy in pseudoexfoliative glaucoma: 24-month follow-up

Sharkawi¹,

Lindegger

Artes

et al. 2020

Br J Ophthalmol

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“…The reason that certain complications are deemed acceptable for some MIGS devices, but not others lies in the context in which they are used. In this regard, in a recent systematic review and consensus derived classification system of reporting harm in glaucoma surgical trials, endothelial cell loss, in the absence of corneal oedema, was noteven a significant consideration for the participating glaucoma surgeons 7. As the first ab-interno glaucoma surgical device which drains to the suprachoroidal space, the Cypass Micro-Stent gained FDA approval through Premarket Approval (PMA), which is the most stringent regulatory category for medical devices.…”

mentioning

confidence: 99%

Minimally invasive glaucoma surgery – coming of age

Sng

Barton

2018

Br J Ophthalmol

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“…Possible n = number. * The complications were graded on a scale from 1 to 10; 1 being clinically insignificant and 10 being most severe (Sii et al 2018). ** Symptomatic cataract decreasing vision at least two lines.…”

Section: Discussionmentioning

confidence: 99%

“…Complications were graded according to severity from 1 to 10 (1 being clinically insignificant and 10 being most severe) based on a recently published classification system of glaucoma surgical complications (Sii et al 2018).…”

Section: Patient Follow-up and Acquisition Of Clinical Datamentioning

confidence: 99%

Effect of glaucoma drainage implant surgery on corneal topography: a prospective study

Koivusalo

Välimäki

2019

Acta Ophthalmologica

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Purpose: To study the effect of glaucoma drainage implant (GDI) surgery on corneal topography during the first postoperative year. Methods: Twenty-one adult glaucoma patients were implanted with a Molteno3 or a Baerveldt 250 GDI. Corneal topography measurements were taken preoperatively and at 6 and 12 months after surgery. Untreated opposite eyes served as controls. Results: In the surgical group, the mean AE SD simulated average keratometry values were 44.36 AE 1.69 D, 44.08 AE 1.29 D (p = 0.266) and 44.15 AE 1.32 D (p = 0.554) before and 6 and 12 months after surgery, respectively. The corresponding simulated keratometry astigmatism values were 1.11 AE 1.11 D, 1.20 AE 1.01 D (p = 0.687) and 1.16 AE 0.71 D (p = 0.177). Posterior astigmatism and posterior average keratometry remained unchanged after GDI surgery as well. The mean AE SD central corneal thickness (CCT) was 530 AE 46 lm, 535 AE 56 lm (p = 0.049) and 536 AE 45 lm (p = 0.080) at 0, 6 and 12 months, respectively. A trend towards increased corneal thickness (CT) in response to GDI surgery was also seen in both the average peripheral and the tube-quadrant peripheral CT values. At 12 months postoperatively, the mean endothelial cell density (ECD) had decreased by 8% centrally and by 9% peripherally. Corneal topography parameters, CT and ECD did not significantly change in the control group during follow-up. Conclusion: Glaucoma drainage implant (GDI) surgery did not significantly alter corneal keratometry parameters and thus seems to be an astigmatically neutral procedure. However a slight, although seemingly transient, increase in CCT was observed after GDI implantation.

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Reporting Harm in Glaucoma Surgical Trials: Systematic Review and a Consensus-Derived New Classification System

Cited by 23 publications

References 73 publications

Outcomes of gonioscopy-assisted transluminal trabeculotomy in pseudoexfoliative glaucoma: 24-month follow-up

Outcomes of gonioscopy-assisted transluminal trabeculotomy in pseudoexfoliative glaucoma: 24-month follow-up

Minimally invasive glaucoma surgery – coming of age

Effect of glaucoma drainage implant surgery on corneal topography: a prospective study

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