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Multicenter clinical assessment of three IOL preloaded delivery systems

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Session Details

Session Title: Presented Poster Session: FLACS & Others

Venue: Poster Village: Pod 1

First Author: : L.Bascaran SPAIN

Co Author(s): :    T. Amzallag   M. Teus   J. Mendicute        

Abstract Details

Purpose:

To determine the corneal incision size, mean corneal incision enlargement, delivery interactions and surgically induced astigmatism after IOL implantation, measured on the surgery day with the new UltraSert, the TECNIS iTec (iTec) and the iSert 250/251 IOL (iSert) preloaded delivery systems.

Setting:

A multi-center clinical study

Methods:

A prospective, multi-center, parallel group, randomized, subject masked, post market clinical study involving the randomized bilateral implantation of monofocal IOLs after phacoemulsification in approximately 25 subjects per treatment group. IOLs were delivered following the manufacturer’s instructions via a 2.2 mm clear corneal incision. Measurements of initial corneal incision size, pre-IOL implantation incision size, and post-IOL implantation incision size were carried using ASICO incision gauges in 0.1mm increments. Visual observations of IOL-Delivery Device interactions were assessed by the surgeon during surgery. Corneal curvature was evaluated before and 1-day post surgery.

Results:

Seventy-one subjects (age: 46-87 years) were randomized and assigned to treatment.The UltraSert group had lowest average post-IOL implantation corneal incision size (2.35mm; 95% CI 2.31, 2.39mm) than iTec (2.47mm; 95% CI 2.44, 2.50mm) and iSert (2.54mm; 95% CI 2.50, 2.58mm);both p<0.001.Mean corneal incision size enlargement was 0.1±0.1mm (UltraSert),0.19±0.1mm (iTec) and 0.3±0.1 (iSert).During delivery, 5 iTec cases (19.2%) had a trapped trailing haptic;six iSert cases (23.1%) had a nozzle tip split and one iSert case 3.8%) had an IOL adhered to the plunger.Overall surgically induced astigmatism was 0.1D (UltraSert), 0.2D (iTec) and 0.48D (iSert).

Conclusions:

UltraSert preloaded delivery system provided smallest final corneal incision size compared to iTec and iSert 250/251 IOL preloaded systems. The UltraSert depth-guard tip may be attributed to its low incision enlargement, no occurrence of nozzle tip split, and low surgically induced astigmatism.

Financial Disclosure:

receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented

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