Standardizing the Yamane flanged intrascleral haptic fixation: A framework for efficacy, complication mitigation, and reproducible training

Table 2 Summary of key studies informing the methodological recommendations

Ref.	Study design	n	Key outcomes/findings	Notable limitations/risk of bias	Role in this review
Yamane et al[1], 2014	Prospective case series	14 eyes	Original description of flanged ISHF; demonstrated secure scleral fixation without sutures	Very small sample; single surgeon; no comparative control group; short follow-up	Foundational technique description
Yamane et al[2], 2017	Prospective case series	100 eyes	Flanged modification introduced; strong centration results; low dislocation rate	Single center; single surgeon; no randomization; retrospective outcome assessment	Primary clinical validation
Stem et al[9], 2019	Retrospective case series	55 eyes	Learning curve analysis; improved outcomes with increasing surgical experience	Retrospective; small sample; variable follow-up; potential selection bias	Learning curve and training
Rocke et al[4], 2020	Retrospective case series	112 eyes	Tunnel geometry analysis; IOL stability data; CT Lucia PVDF haptic outcomes	Retrospective; heterogeneous surgical technique across cases; variable follow-up	Tunnel geometry & IOL stability
Schranz et al[11], 2023	Comparative retrospective study	78 eyes	AR40e vs CT Lucia outcomes; haptic behavior and flange formation comparison	Retrospective; limited long-term follow-up; single center; small groups	IOL model comparison
Zhang et al[5], 2024	Systematic review & meta-analysis	1847 eyes (pooled)	Pooled CME rate approximately 13%-14%; favorable visual outcomes; shorter OR time vs sutured fixation	High heterogeneity across included studies; retrospective designs dominate; variable definitions of complications	Broadest comparative evidence
LoBue et al[17], 2024	Bench/cadaveric experimental study	Ex vivo (4 IOL models)	Haptic tensile strength: CT Lucia 153 N > MA60AC 1.00 N > AR40e 087 N > LAL 0.83 N	Non-clinical; ex vivo findings may not fully predict in vivo behavior; limited generalizability	Haptic material & tensile strength

Studies are listed chronologically. CME: Cystoid macular edema; IOL: Intraocular lens; ISHF: Intrascleral haptic fixation; PVDF: Polyvinylidene fluoride; PMMA: Polymethylmethacrylate; LAL: Light-adjustable lens; OR: Operating room.