BIO-INTERVENTIONAL CYCLODIALYSIS AND SCLERAL REINFORCEMENT

 

Iantrek, a company based in the USA, has developed a bio-interventional cyclodialysis and scleral reinforcement procedure. It is being used in open-angle glaucoma (OAG) patients undergoing cataract surgery. 

CYCLO-PEN

SCAFFOLD IMPLANTATION

An ab-interno approach is used to create a sectoral cyclodialysis in OAG patients. Subsequently, visco-cycloplasty with scleral reinforcement using a homologous minimally modified allograft scaffold is performed to maintain the patency of the cyclodialysis reservoir and increase uveoscleral outflow.

From a mechanistic standpoint, cyclodialysis has a dual mechanism of IOP lowering, through increased uveoscleral outflow as well as reduction in aqueous production from the detached ciliary body.

Bio-reinforced cyclodialysis technique uses adjunct allogeneic scleral tissue scaffolding as reinforcement to prevent the premature closure of the cyclodialysis intervention by maintaining a permanent uveoscleral conduit for aqueous outflow. An internal uveoscleral filtration reservoir is thus supported by the allogeneic bio-scaffold, which acts as a biologic non-absorbable spacer between the ciliary body and the adjacent scleral wall.

The CREST clinical study is a real-world evidence registry in which patients are followed prospectively through 24 months after undergoing cyclodialysis intervention. The results of a multi-center study involving 12 surgeons from the CREST US and OUS clinical studies have been published recently.

As per the results of the study, successful cyclodialysis and allograft bio-scaffold reinforcement was achieved in 117 eyes.

At baseline, mean BCVA was 0.48 (95% CI: 0.42‒0.54; 20/40 Snellen), and mean ± SD medicated IOP was 20.2 ± 6.0 mmHg on 1.4 ± 1.3 IOP-lowering medications.

At 12 months, there was a 27.1% reduction from baseline mean medicated IOP. In eyes with medicated baseline IOP > 21 mmHg (n = 45), there was a 39.7% paired IOP reduction at 12 months with a concurrent reduction in the mean number of IOP lowering medications to 0.8 ± 0.9 which was statistically significant (p < 0.01).

81.9% of eyes achieved a medicated IOP ≤ 18 mmHg with no increase in medications at 12 months.

Complications included minimal blood reflux from the cyclodialysis cleft, which was not associated with any significant postoperative hyphema, transient hypotony occurred in one eye, three patients who underwent concurrent phaco surgery developed cystoid macular edema,

Secondary glaucoma surgery such as Selective Laser Trabeculoplasty (SLT), Ahmed Valve or Xen-gel implantation, and cyclophotocoagulation was performed in 3.2% of the cases.

REFERENCE:

Ianchulev T, Weinreb RN, Calvo EA, Lewis J, Kamthan G, Sheybani A, Rhee DJ, Ahmed IK. Bio-Interventional Cyclodialysis and Allograft Scleral Reinforcement for Uveoscleral Outflow Enhancement in Open-Angle Glaucoma Patients: One-Year Clinical Outcomes. Clin Ophthalmol. 2024;18:3605-3614. https://doi.org/10.2147/OPTH.S496631.

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https://iantrekmed.com/