Intraocular lens position stability during phacovitrectomy with air or gas tamponade

doi:10.21203/rs.3.rs-5276306/v1

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Intraocular lens position stability during phacovitrectomy with air or gas tamponade

https://doi.org/10.21203/rs.3.rs-5276306/v1

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To evaluate the stability of different intraocular lens (IOL) after phacovitrectomy with air or gas tamponade.Twenty-eight patients who underwent phacovitrectomy with air or sulfur hexafluoride (SF₆) gas tamponade and who underwent postoperative anterior segment optical coherence tomography assessments using CASIA2 (TOMEY, Inc., Japan), were included in the study.Patients who received any of DIB00V (Johnson & Johnson Surgical Vision, Inc., USA), XY-1 (HOYA Surgical Optics Co., Japan), or NX70 (Santen Pharmaceutical Co.) implantation were analyzed. The the anterior chamber depth (ACD) and IOL position values at each measurement time point (100%, 50%, 0%) and between IOLs were compared. The IOL displacement force (mN) was measured with verification experiment and recorded at each 0.1 mm anterior movement until the anterior displacement reached 0.5 mm. The overall age was 66 (59, 73) (median [quartiles])years. The ACD values increased progressively as the postoperative gas decreased for all IOLs. Compared to the preoperative ACD, the postoperative ACD was significantly greater at 50% and 0% gas for all IOLs (P < 0.01). Additionally, DIB00V had significantly larger ACD values compared to XY-1 at 100% gas or air (P=0.023) and NX70s at 0% gas or air (P=0.008). The IOL position shifted significantly posteriorly for both DIB00V and XY-1 as the gas or air dissappeared (P<0.05). However, for NX70s, the position significantly increased from 100% to 50% (P<0.01), with no significant difference from 50% to 0% (P=0.444). IOL-by-IOLs comparisons at each time point showed that DIB00V was significantly more posterior than XY-1 at 100% (P=0.046). In the verification experiment, DIB00V showed a greater IOL displacement force against a push from the retinal surface compared to XY-1 and NX70s.DIB00V exhibited excellent Z-axis stability in phacovitrectomy with air or gas tamponade.

Health sciences/Anatomy/Nervous system/Sensory systems/Visual system

Health sciences/Anatomy/Nervous system/Sensory systems/Visual system/Retina

phacovitrectomy

intraocular lens position

gas tamponade

anterior chamber depth

stability

intraocular lens displacement

Postoperative refractive error has long been of great interest to cataract surgeons aiming for superior postoperative visual function after cataract surgery. While advancements in various formulas have improved the accuracy of postoperative refraction in cataract surgery alone, challenges persist, particularly in cases involving phacovitrectomy^[1–5].

Some studies suggest that simultaneous vitreous surgery does not change refractive error compared to cataract surgery alone^[6], while others suggest that it causes myopia^[7–9]. Thus, managing postoperative refractive error in phacovitrectomy is more complex than in cataract surgery alone.

In particular, when gas tamponade is performed during vitrectomy, the postoperative anterior chamber depth (ACD) is shallower compared to cases without tamponade^[8]. Additionally, ACD increases with loss of gas when gas tamponade is performed^[10]. Various intraocular lens (IOL) types, including one-piece, three-piece, 6 mm, and 7 mm lenses, exhibit different lens stability^{[11, 12]}. IOL stability in the z-axis direction for gas tamponade may be one of the factors that influences postoperative refraction.

This study evaluates the stability of different IOLs after phacovitrectomy with air or gas tamponade.

The overall age was 66 (59, 73) (median [quartiles]) years; the DIB00V (Johnson & Johnson Surgical Vision, Inc., USA) group (n = 11) was 67 (58, 76)years, the NX70s (Santen Pharmaceutical Co., LTD, Japan) group (n = 8) was 66 (58, 77) years, and the XY-1 (HOYA Surgical Optics Co., Japan) group (n = 9) was 64 (59, 73) years, with no significant differences between IOLs. There were also no differences in sex, axial length, lens thickness, ratio of air and sulfur hexafluoride (SF₆), or time to CASIA2(TOMEY, Inc., Japan) examinations (Table 1).

Table 1

Demographic and clinical characteristics of each intraocular lens group.
	Overall (n = 28)	DIB00V (n = 11)	NX70s (n = 8)	XY-1 (n = 9)	P-value
Age, years	66 (59, 73)	67 (58, 76)	66 (58, 77)	64 (59, 73)	0.8000*
Sex (female/male), n	12/16	4/7	6/2	2/7	0.0769^†
Axial length, mm	24.2 (23.2, 25.0)	24.2 (23.3, 25.3)	23.6 (23.2, 24.5)	24.2 (22.7, 25.3)	0.7903*
Lens thickness, mm	4.56 (4.38, 4.85)	4.5 (4.4, 4.6)	4.5 (4.2, 4.9)	4.8 (4.3, 5.0)	0.3835*
Air/SF₆, n	10/18	6/5	2/6	2/7	0.2456^†
Time to examination (50%), days	6 (4, 7)	6 (5, 8)	6 (4, 7)	6 (3, 10)	0.8109*
Time to examination (0%), days	26 (12, 39)	26 (17.8, 41.3)	30 (14, 43)	18 (12, 42)	0.9367*

The refractive error values were 0.09 (-0.50, 0.51) diopters for DIB00V, -0.03 (-0.45, 0.45) diopters for NX70s, and 0.16 (-0.20, 0.70) diopters for XY-1, with no significant differences observed between the IOLs.

The ACD values increased progressively as the postoperative gas decreased for all IOLs. Compared to the preoperative ACD, the postoperative ACD was significantly greater at 50% and 0% gas for all IOLs (P < 0.01). However, for the XY-1 lenses, there was no significant difference in ACD values between preoperative and 100% air or gas (P = 0.489), and for NX70s, there was no significant difference at 50% and 0% air or gas (P = 0.586). Additionally, DIB00V had significantly larger ACD values compared to XY-1 at 100% gas or air (P = 0.023) and NX70s at 0% gas or air (P = 0.008) (Fig. 1).

The IOL position shifted significantly posteriorly for both DIB00V and XY-1 as the gas or air disappeared (P < 0.05). However, for NX70s, the position significantly increased from 100–50% (P < 0.01), with no significant difference from 50–0% (P = 0.444). IOL-by-IOLs comparisons at each time point showed that DIB00V was significantly more posterior than XY-1 at 100% (P = 0.046) (Fig. 2).

In the verification experiment, DIB00V required a greater IOL displacement force against a push from the retinal surface compared to XY-1 and NX70s (displacement force at 0.5 mm: DIB00V, 2.45 mN; XY-1, 1.04 mN; NS70s, 0.64 mN) (Fig. 3).

The axial distances immediately after the 0.5 mm push (0 h) were 0.775 mm for DIB00V, 0.441 mm for XY-1, and 1.213 mm for NX70s. After 48 h of 0.5 mm push, the axial distances were 0.770 mm for DIB00V, 0.386 mm for XY-1, and 1.038 mm. The percentage change in axial distance was smallest for DIB00V (0.65%), compared to 12.5% for XY-1 and 14.4% for NX70s (Fig. 4).

A representative case is shown in Fig. 5. With the one-piece IOL (DIB00V, XY-1), the ACD deepened as the tamponade material decreased, and the IOL position shifted toward the retinal plane. In contrast, the three-piece IOL (NX70S) showed minimal changes in ACD and IOL position between 50% and 0%. At all time points, the DIB00V IOL was positioned closer to the retinal plane than the XY-1 and NX70s IOLs.

This study examined the z-axis stability of the one-piece IOLs DIB00V and XY-1 and the three-piece IOL NX70s under air or SF₆ gas tamponade. In phacovitrectomy, three-piece IOLs and large-diameter IOLs are generally preferred due to their intracapsular stability and better fundus visibility through the IOL^{[13, 14]}. However, in recent years, the insertion of premium IOLs has been attempted in cases of epiretinal membrane^{[15, 16]}. Given the importance of refractive correction in phacovitrectomy, there is a growing need for one-piece IOLs.

Previous studies have shown that when IOL optics were pushed in the z-axis from the posterior side, the stability of NS60YG (NIDEK Co., LTD, Japan), YP2.2 (KOWA Co., LTD, Japan), and ZCB00V (Johnson & Johnson Surgical Vision, Inc., USA ) was higher than that of SN60WF (Alcon Laboratories Inc, USA ), XY-1, 255 (HOYA Surgical Optics Co., Japan ), XY-1, and 255^[12]. Additionally, NS60YG demonstrated superior stability compared to X70 (Santen Pharmaceutical Co., LTD, Japan ), a large aperture three-piece lens^[11]. In our clinical study, DIB00V exhibited greater ACD and IOL position values at 100% gas or air than XY-1. From the results of the validation experiments, DIB00V was more resistant to IOL displacement forces than XY-1 and NX70s.

DIB00V has the same lens design as ZCB00V (TECNIS series, Johnson & Johnson), which has been reported to be more stable than XY-1 against pressure loading from behind the IOL (in the z-axis direction) in an experimental system^[12], as in this study. This indicates that the TECNIS series lens design has excellent z-axial stability.

For the one-piece lenses, the IOL position progressively shifted backward, and the IOL position value increased as the pressure load decreased due to the decrease in gas or air; however, the NX70s group showed no significant change from 50–0%. The ACD at 0% in the NX70s was significantly smaller than that of the DIB00V. The value of the IOL position was previously reported as approximately 0.35–0.36 for cataract surgery alone^[8]. In our study, the IOL position for DIB00V at 0% was 0.35, indicating that, even with phacovitrectomy with tamponade, DIB00V returned the IOL to the same position with cataract surgery alone once the tamponade material disappeared. Conversely, for the NX70s, the IOL positions were more anterior than those reported for cataract surgery alone, with no change in ACD or IOL positions from 50–0%. Validation experiments showed that 48 h of loading caused IOL deformation, particularly in the NX70s, which showed the greatest deformation.

It is suggested that in the NX70s group, loading from backward by the air or gas in the z-axis direction caused IOL deformation, resulting in the IOL position remaining fixed anteriorly after the tamponade material disappeared. Although there were no significant differences in refractive error among the three groups, the median values showed a shift toward hyperopia in DIB00V and myopia for NX70s, suggesting an effect of the IOL position. However, this study could not identify the factors influencing the reversibility of the lens position. The stability of IOLs depends on the haptic junction area^[12], number of haptics, and shape^[17]. The shape and material of the haptics may also influence IOL reversibility.

This study has several limitations, including a small sample size, multiple surgeons, and the use of two tamponade materials. However, in our study, continuous curvilinear capsulorhexis provided complete coverage of the IOL optics in all surgeries, and the ratio of air to SF₆ gas did not significantly differ among the three groups. The degree of peripheral vitreous shaving likely varies depending on the underlying disease. Careful vitreous dissection may have been performed, particularly in cases where NX70s were selected. When the most peripheral vitreous is shaved, the IOL should be shifted posteriorly due to the vulnerability of the ligament of Zinn^[18]. This study showed that the NX70s group was more anteriorly positioned than other IOL groups. Therefore, even if the NX70s group included more eyes with careful vitreous shaving, the ACD depth may have been underestimated; however, this would have had minimal impact on the study’s results.

The clinical data in this study were obtained approximately 30 days postoperatively. The experimental data also evaluated lens shape recovery after 48 h and immediately after the release of compression. Therefore, long-term changes in IOL shape after the loss of air or gas could not be assessed. Additionally, postoperative positioning and resting periods may differ depending on the causative disease, and the degree of backward pressure on the IOL may differ depending on the postoperative positioning. However, this effect was not considered in the present study. Future studies are needed which unify gas types and postoperative positional restrictions.

Study design

This retrospective cross-sectional study was approved by the Ethics Committee of Saitama Medical University, Iruma, Japan. (Application No. 2023-095) The study adhered to the tenets of the Declaration of Helsinki and opt-out informed consent was obtained from each participant.

Study participants and examinations

Twenty-eight patients who underwent phacovitrectomy with air or SF₆ gas tamponade at Saitama Medical University Hospital between January and July 2023 and who underwent postoperative anterior segment optical coherence tomography assessments using CASIA2 (TOMEY, Inc.), were included in the study.

Cataract surgery was performed through a 2.4 mm corneal incision, along with simultaneous 25- or 27-gauge pars plana vitrectomy (PPV) by a retinal specialist. A continuous curvilinear capsulotomy was created to completely cover the IOL optics. The trocar was inserted into the vitreous cavity at an angle of 30° to the scleral surface, positioned 3.5 mm posterior to the corneal limbus. All patients underwent peripheral vitreous shaving and fluid-air exchange. The intraocular vitreous cavity was replaced with 20% SF₆ from air, depending on intraoperative findings. The surgery was completed with the IOL and vitreous cavity filled with either air or 20% SF₆.

Patients who received any of DIB00V, XY-1, or NX70 implantation were analyzed. CASIA 2 (TOMEY, Inc.) was used to measure ACD preoperatively at 100%, 50%, and 0% residual air or SF₆ gas. The IOL position was expressed as the ratio of the difference between preoperative and postoperative ACD to the thickness of the lens (i.e., postoperative ACD – preoperative ACD) to lens thickness, as previously reported^[11] (Fig. 6).

The difference between the subjective refraction value at 0% gas and the preoperatively predicted refraction value, measured using OA2000 (TOMEY, Inc.) and CASIA 2 (TOMEY, Inc.), was defined as the refractive error. The ACD and IOL position values at each measurement time point were compared using the Wilcoxon signed-rank test with Bonferroni correction for each IOLs. Comparisons of ACD and IOL position between IOLs at each time point were evaluated using the Steel-Dwass test. All values were presented as median [quartiles], and all statistical analyses were performed with JMP 10.1 (SAS Institute Cary NC). P-value < 0.05 was considered statistically significant.

Verification experiment

The IOL displacement force was measured as previously reported^{[11, 12]}.

All selected IOLs were + 21 diopters. The IOLs were placed in a 10 mm diameter holder at room temperature (31°C). To simulate the drag force produced when the IOL is pushed from the retinal surface side, the IOLs were pushed on the posterior side by a digital micrometer head (3.0 mm diameter; Mitutoyo, Kawasaki, Japan) until they moved 0.5 mm anteriorly. The IOL displacement force (mN) was measured when the values were stabilized using an electronic balance (SHIMADZU, Kyoto, Japan) and recorded at each 0.1 mm anterior movement until the anterior displacement reached 0.5 mm (Fig. 7a).

To further evaluate the reversibility of the IOL, the axial-distance in the z-axis direction between the optics and haptics was measured immediately after the IOL was pushed 0.5 mm (0 h) and 48 h later. All distances were measured with the IOL removed from the fixture, and the push-in was released (Fig. 7b).

DIB00V exhibited excellent Z-axis stability in phacovitrectomy with air or gas tamponade.

Author Contribution

Y.Y. and T.M collected the data, analysed the ophthalmological findings, and gave critical suggestions. Y.Y. prepared the figures and the draft. K.S., J.M., S.T. and T.M. revised it, and Y.Y finalised it. All authors agreed to be accountable for all aspects of the work. Patient anonymity is preserved. All authors attest that they meet the current ICMJE criteria for authorship.

Acknowledgement

The authors would like to thank Editage (https://www.editage.jp) for the English language review and Shinji Nagasaka et al.,(NIDEK Co., LTD) for conducting verification experiment

Data Availability

The datasets used and/or analysed during the current study available from the corresponding author on reasonable request.

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No competing interests reported.

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You are reading this latest preprint version

Intraocular lens position stability during phacovitrectomy with air or gas tamponade

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Version 1

Abstract

Figures

Introduction

Results

Discussion

Methods

Study design

Study participants and examinations

Verification experiment

Conclusion

Declarations

Author Contribution

Acknowledgement

Data Availability

References

Additional Declarations

Status:

Version 1