Comparison of incision size and intraocular lens performance after implantation with three preloaded systems and one manual delivery system

Figures & data

Figure 1 The UltraSert^® preloaded delivery system.

Notes: The UltraSert preloaded delivery system (Alcon Laboratories, Inc., Fort Worth, TX, USA) is a single-use system made up of a nozzle, main body, and plunger that delivers the preloaded IOL by manually advancing the plunger with a push mechanism. The system is Food and Drug Administration (FDA)-approved for use with the AcrySof^® IQ Aspheric IOL (Alcon Laboratories, Inc.) in patients undergoing cataract surgery.
Abbreviation: IOL, intraocular lens.

Table 1 Study population demographics and baseline characteristics

	Preloaded system U, N=19	Preloaded system T, N=26	Preloaded system S, N=26	Manual delivery system, N=28
Age (years)
Mean (SD)	71.4 (8.7)	70.7 (8.31)	73.0 (7.27)	72.5 (7.1)
Sex
Female, n (%)	14 (73.7)	13 (50.0)	14 (53.8)	17 (60.7)
Race
White, n (%)	19 (100.0)	26 (100.0)	26 (100.0)	28 (100.0)
Preoperative UCDVA (logMAR)
Mean (SD)	0.58 (0.4)	0.53 (0.3)	0.60 (0.4)	0.66 (0.3)
Preoperative absolute keratometry (K1–K2) (diopters)
Mean (SD)	0.57 (0.2)	0.56 (0.3)	0.55 (0.2)	0.46 (0.3)
Preoperative IOP (mmHg)
Mean (SD)	14.7 (2.0)	14.9 (2.9)	15.3 (2.4)	15.6 (3.1)

Abbreviations: IOP, intraocular pressure; UCDVA, uncorrected distance visual acuity.

Figure 2 Mean corneal incision size after intraocular lens implantation of preloaded systems or manual delivery system.

Notes: (A) Preloaded system U had the smallest mean corneal incision size among the preloaded devices. Preloaded systems T and S resulted in significantly greater mean corneal incision sizes. (B) Preloaded system U resulted in a significantly smaller mean corneal incision size than the manual delivery system. Data presented as mean ± standard error; n=19 eyes for preloaded system U, 26 eyes for preloaded system T, 26 eyes for preloaded system S, and 28 eyes for the manual delivery system. *Statistical significance (P<0.025), as determined by a two-sample t-test based on superiority hypothesis testing as compared to preloaded system T, system S, or the manual delivery system.

Figure 3 Mean corneal incision size enlargement caused by IOL delivery using preloaded systems or manual delivery system.

Notes: (A) Preloaded system U had the least corneal incision enlargement among the preloaded devices. Incision enlargements following IOL insertion using preloaded system T and system S were greater than those of system U. (B) The manual delivery system resulted in less corneal incision enlargement than preloaded system U and had the least mean corneal incision enlargement of all the devices tested. Data presented as mean; n=19 eyes for preloaded system U, 26 eyes for preloaded system T, 26 eyes for preloaded system S, and 28 eyes for the manual delivery system.
Abbreviation: IOL, intraocular lens.

Figure 4 SIA following implantation of preloaded systems or manual delivery system.

Notes: (A) Less SIA was observed in patients following intraocular lens insertion using preloaded system U than that of systems T and S. (B) Preloaded system U also resulted in less SIA than the manual delivery system. Data presented as mean; n=19 eyes for preloaded system U, 26 eyes for preloaded system T, 26 eyes for preloaded system S, and 28 eyes for the manual delivery system.
Abbreviations: D, diopters; SIA, surgically induced astigmatism.

Table 2 Observations of IOL–delivery device interactions and surgically induced astigmatism

	Preloaded system U, N=19	Preloaded system T, N=26	Preloaded system S, N=26	Manual delivery system, N=28
Trapped trailing haptic, n (%)	0 (0.0)	5 (19.2)	0 (0.0)	0 (0.0)
Plunger tip adherence, n (%)	0 (0.0)	0 (0.0)	1 (3.8)	0 (0.0)
Nozzle tip splitting, n (%)	0 (0.0)	0 (0.0)	6 (23.1)	0 (0.0)
Overall surgically induced astigmatism, diopters (axis)	0.10 (83.06)	0.20 (94.00)	0.48 (65.16)	0.33 (37.84)

Abbreviation: IOL, intraocular lens.

Table 3 Treatment emergent ocular adverse events (serious and nonserious)

	Preloaded system U, N=19	Preloaded system T, N=26	Preloaded system S, N=26	Manual delivery system, N=28
Cataract operation complication, n (%)	0 (0.0)	1 (3.8)	0 (0.0)	0 (0.0)
Corneal edema, n (%)	0 (0.0)	0 (0.0)	1 (3.8)	0 (0.0)
Surgical procedure repeated, n (%)	0 (0.0)	1 (3.8)	0 (0.0)	0 (0.0)