Effectivity of V4 and v4C implantable contact lenses in the treatment of complications after vitreoretinal surgery: A comparative study

doi:10.21203/rs.3.rs-807333/v1

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Effectivity of V4 and v4C implantable contact lenses in the treatment of complications after vitreoretinal surgery: A comparative study

https://doi.org/10.21203/rs.3.rs-807333/v1

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Objective

This study aims to analyze and compare the postoperative ocular parameters of two different types of implantable contact lenses (ICLs) (for retinal detachment) to provide a clinical reference for vitreoretinal surgery.

Methods

From March 2016 to March 2021, 24 patients (24 eyes) with rhegmatogenous retinal detachment following ICL implantation at the Eye Center of Taizhou Central Hospital were recruited. Based on the different types of ICL, they were divided into the V4 type ICL implantation group (V4 type group) and v4C type ICL implantation group (v4C type group), with 12 cases (12 eyes) in each group. Both groups were treated with pars plana vitrectomy; differences in postoperative ocular complications between the two groups were compared.

Results

The postoperative uncorrected and best corrected visual acuity for both groups were significantly higher than those preoperatively (P < 0.001); the same applied to the intraocular pressures (P < 0.05). Fluctuation in intraocular pressure was higher in the V4 group than in the v4C group (P < 0.05). The arch height, measured using anterior segment optical coherence tomography on the first day after operation, was lower in the V4 group than in the v4C group (P < 0.05). There was also no significant difference between the two groups before and after the operation (P > 0.05).

Conclusion

For patients with V4 type ICL implantation and mesh removal, stimulation of the ciliary body and the risk factors for pupil block caused by ciliary muscle spasm should be reduced as much as possible during pars plana vitrectomy. If postoperative complications such as decreased arch height and increased intraocular pressure occur, the application of compound tropicamide eye drops is an effective method to activate the pupil.

Ophthalmology

implantable contact lens

pars plana vitrectomy

arch height

When the eye is still, external parallel light beyond 5 m cannot focus on the fovea of the retina, after passing through the refractive system of the eye. Consequently, this will lead to the failure to produce a clear image (refractive error) [1]. Prevention and treatment have become national and ophthalmic strategic issues. Phakic intraocular lens (IOL) implantation is widely used to correct refractive errors in corneal refractive surgery. The implantable contact lens (ICL) is the only one approved by the Food and Drug Administration and is most widely used in correction of ametropia in patients with posterior chamber IOL [2–5].

V4 type ICL is the first posterior chamber IOL, developed by Staar (nascaq: sTAA). However, because it has the risk of inducing pupil block and causing glaucoma, it is necessary to perform YAG laser peripheral iridotomy before surgery. Nearly 10 years later, v4C, which is a new type of crystal for IOL, was introduced. It adopts a central 360-µm diameter hole design, which can simulate the physiological circulation of aqueous humor, overcome the disadvantages of conventional laser peripheral iridotomy before IOL surgery, stabilize the intraocular pressure, and reduce complications such as white cataract or anterior capsular opacity caused by poor aqueous circulation [6–7] (Fig. 1a, c).

Vitreous body complications are a common cause of refractive error in patients with pathological myopia. The incidence rate of vitreoretinal disease following ICL implantation increases annually with increasing patient age. This article mainly discusses the correlation between the complications of V4 and v4C ICL implantation through pars plana vitrectomy (PPV) to provide a basis for clinical observation after ICL insertion.

The Ethics committee of Taizhou Central Hospital approved the clinical observations to meet ethical requirements (2021L-03-18). All methods were performed in accordance with the tenets of the Declaration of Helsinki. Written Informed consent was obtained from patient of the subjects following detailed explanation of the nature and possible consequences of the study.

Patients

From 2016 to 2021, patients with porogenic reticulum detachment after V4 and v4C ICL insertion were divided into two groups for retrospective analysis: 12 (12 eyes) in each group. The follow-up time and frequency in the two groups were standardized (p = 0.849). There were no abnormal corneal topography findings, endothelial cell count less than 2000/mm², and anterior chamber depth less than 2.80 mm, in both groups. PPV was performed in all patients according to the principle of vitrectomy.

Comparison of preoperative and postoperative parameters

Uncorrected and best corrected visual acuity (UCVA and BCVA), intraocular pressure (IOP), mydriasis, fundus examination, corneal endothelium count, anterior chamber depth (ORB scan II), and arch height (front optical coherence tomography) were investigated.

Pars plana vitrectomy

All PPVs were performed by one surgeon. Since 3 days preoperatively, 0.5% levofloxacin eye drops (Shentian Pharmaceutical [China] Co., Ltd; J20150106; Cv1992 and Senju Pharmaceutical Co., Ltd; H20130682; R382) were administered q.i.d to clean the conjunctival sac, and compound tropicamide eye drops (Shenyang Xingqi Ophthalmic Co., Ltd; Shenyang Xinqi ophthalmic Co., Ltd; Shenyang Xinqi Ophthalmic Co., Ltd; H20055546) were administered 1 h preoperatively, resulting in a pupil size of approximately 7 mm. The operation was completed using an Alcon constellation all-in-one machine, and the brief introduction was as follows: conventional 25 g three-channel incision assisted by a Zeiss non-contact wide-angle lens rest, central axis vitrectomy under light-guided fiber, triamcinolone acetonide acetate (Zhejiang Xianju Pharmaceutical Co., Ltd; H2003354), flattening of retina with heavy water, and gas-liquid exchange under 35 mmHg perfusion. The three rows of holes and the degenerative areas were closed using a laser. The eyes were filled with silicone oil (SiO), and the trocar was pulled out; intraocular application of tobramycin and dexamethasone eye ointment (Alcon, CUSI, s, a; H20181126; Okfb1a. Allergan pharmaceuticals Ireland; H20171243 E89081) q.i.d, 0.5% levofloxacin eye drops (Colbutol) (Shentian Pharmaceutical [China] Co., Ltd; J20150106; Cv1992) q.i.d, and ursapharm arzneimittel GmbH; sodium hyaluronate eye drops (Hailu; H20150150; 299488) t.i.d were administered till 1 month after operation.

Data processing

SPSS software was used for analysis. The Mann–Whitney U nonparametric test was used to determine differences between the V4 and v4C ICL groups. Spearman’s correlation analysis was used for different types of analysis (P < 0.05).

A total of 24 eyes (24 patients) were included in this study. PPV was performed after implantation of V4 ICL and v4C ICL, in 12 eyes (12 patients) each. The average ages of patients in the V4 and v4C ICL groups were 31.08 ± 78 (18–45 years) and 24.57 ± 6 9 (18–55 years), respectively, while the average follow-up periods were 7.64 ± 87 (1–18 months) and 7.38 ± 62 (1–17 months), respectively. There was no significant difference in preoperative mean spherical equivalent, mean cylindrical equivalent, UCVA, and BCVA between the two groups (P = 0.386, 0.740, 0.198, and 0.721, respectively). The IOP of the v4C ICL group was higher than that of the V4 ICL group (P = 0.022). There was a significant difference in corneal endothelial count between the two groups preoperatively, but the cell count was higher than 2000/mm² (P = 0.006) in both groups. The baseline data for the two groups are shown in Table 1.

Table 1

Comparison of baseline characteristics between the two groups (V4 group: v4C group)
	V4型ICL	V4c型ICL	t	P值
Patient (eye)	12(12)	12(12)
Average age	31.08 ± 7.78 (18–45)	24.54 ± 7.91 (18–55)	1.15	0.001^*
Gender (male: female)	9: 15	4: 20	-	0.193^#
Follow up period (months)	7.64 ± 4.87	7.64 ± 4.87	0.06	0.869^*
Myopia diopter (D)	-10.68 ± 2.44 (-15.68 - -5.57)	-9.91 ± 2.98 (-14.25 - -4.13)	0.76	0.386^*
Time of disconnection (days)	2.50 ± 1.24 (1.00–5.25)	2.34 ± 0.76 (1.25–4.00)	0.34	0.740^*
Visual acuity (logarithmic chart)
UCVA	0.02 ± 0.63 (0.02–0.04)	0.06 ± 0.48 (0.02–0.06)	0.23	0.198^*
BSCVA	0.06 ± 0.02 (0.00–0.30)	0.08 ± 0.07 (0.00–0.20)	-0.64	0.721^*
IOP(mmHg)	15.15 ± 3.28 (8.90–21.00)	17.33 ± 2.52 (13.00–21.50)	0.54	0.022^*
Corneal endothelial- cell count (/mm²)	2879.46 ± 412.51	3224.33 ± 291.78	0.61	0.006^*
D (diopter); UCVA (uncorrected visual acuity); BCVA (best corrected visual acuity)* Mann-Whitney U test

Comparison of uncorrected and best corrected visual acuity between the two groups

UCVA and BCVA of the two groups after surgery were higher than those before surgery (P < 0.001). There was no significant difference in UCVA and BCVA between the two groups (P > 0.05) (Table 2).

Table 2

Uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA after pars plana vitrectomy (V4: v4C)
Visual acuity (logarithmic chart)	V4型ICL	V4c型ICL	t	P*
UCVA(range)	0.4 ± 0.06(0.2–0.6)	0.3 ± 0.07(0.1-05)	-0.57	0.111
BSCVA(range)	0.8 ± 0.02(0.5-1.0)	0.6 ± 0.08(0.4-1.0)	-0.13	0.122

Comparison of intraocular pressures between the two groups

The mean IOP of the V4 and v4C ICL groups preoperatively were 15.15 ± 28 (8.90–21.00) mmHg and 17.33 ± 2.52 (13.00–21.50) mmHg, respectively, with a significant difference between the two groups (P > 0.05). There was a significant difference in IOP between the two groups before and after surgery (P = 0.022 and 0.006, respectively). The average IOP changes in the V4 and v4C ICL groups were 6.11 ± 3.08 (-6.00–5.00) mmHg and 0.65 ± 2.08 (-4.00–4.50) mmHg, respectively. In the V4 ICL group, three patients had transiently elevated IOP on the first day after PPV, which was accompanied by headache, nausea, and other symptoms. The average IOP was 30.97 mmHg (29.25, 30.22, 33.45). The IOP returned to normal levels (10–21 mmHg) after pupil movement was initiated using compound tropicamide eye drops.

Comparison of the corneal endothelial count between the two groups

Preoperative corneal endothelial count was higher in the v4C group than in the V4 group, and the difference was significant (P = 0.006). There was no significant difference in the corneal endothelial count between the two groups (P = 0.789), postoperatively. The corneal endothelial counts in V4 and v4C ICL groups decreased by 84.46 ± 13.27% (64.44–96.69) and 119.08 ± 20.82% (85.98–132.35), respectively.

Comparison of arch height between the two groups

There was a significant difference in arch height between the V4 and v4C ICL groups (P = 0.006). The preoperative arch height of the V4 type was significantly higher than that of the v4C type (P = 0.006). On the first day after PPV, the arch height in the V4 and v4C ICL groups decreased by 110.67 ± 58% (77.75–126.58) and 10.58 ± 3.65% (6.45–14.68), respectively. There was no significant difference between the two groups (P > 0.05) (Fig. 2).

Comparison of the recurrence rate of retinal detachment between the two groups

There was no significant difference in the recurrence rate of retinal detachment between the two groups (P > 0.05).

Myopia is one of the most common refractive errors [8]. In 2015, a study showed that the prevalence of myopia was 22.9% and 70–80% in adults and adolescents, respectively [9, 10]. A recent study showed that up to 90% of teenagers and young people worldwide experience ametropia [11]. High myopia refers to myopia of more than 6 days, which is characterized by axial length and progressive pathological damage of the retina. Patients are often prone to complications with vitreoretinal diseases such as posterior scleral staphyloma, rhegmatogenous retinal detachment, macular splitting, and other blinding conditions [12]. Therefore, high myopia is the fourth to seventh most common cause of blindness [13–15]. ICL has become the commonest method for correcting myopia, especially high myopia. The latest generation of ICLs is the fourth generation (V4 and v4C). V4C is based on V4 but has an additional central hole (0.36 mm), and the design of this “central flow technique” can adjust the compliance of aqueous humor flow between the ICL and the crystalline lens to avoid preoperative peripheral iridotomy (Fig. 1A, C). This study mainly compared ocular complications after PPV in ICL patients with rhegmatogenous retinal detachment to determine the differences in ocular parameters between the two different types of ICL crystals (V4 and v4C) after PPV and provide guidance for clinicians. This study revealed that the arch height of V4 type ICL after PPV was significantly reduced compared with that of v4C type ICL (P > 0.05), which resulted in transient high IOP symptoms that may be related to the transient spasm of the ciliary muscle caused by jacking the ciliary body during vitrectomy (Fig. 2A, B).

A retrospective case study by Huseynova et al. [16] showed that there was no significant difference in UCVA and BCVA between V4 type ICL and v4C type ICL, 3 months after surgery. This study followed up patients with rhegmatogenous retinal detachment following ICL implantation for 1–18 months, after PPV. Similarly, we found that, V4 and v4C ICL can significantly improve the visual acuity in patients with ametropia (Table 1). Although patients with ametropia had rhegmatogenous retinal detachment, they can still obtain satisfactory visual quality after active treatment. Lapeyre et al. [17] presented a case of rhegmatogenous retinal detachment following ICL implantation. After PPV, the anterior segment and omentum were reattached, and patients followed up for 2 years had no related complications. This study showed that there was no significant difference in the corneal endothelial cell count between V4 ICL and v4C ICL after PPV for the two groups, suggesting that vitreoretinal surgery had little effect on the position of the ICL as well as damage to the cornea. No serious complications, such as recurrent retinal detachment occurred in both groups, indicating that ICL implantation had no significant effect on the retinal reattachment rate in PPV surgery.

High intraocular pressure after ICL implantation may be caused by the following factors: pupil block due to lens diameter or thickness [18], the aqueous humor returning to the vitreous cavity [19], pigment dissemination [20], hormone correlation [21], intraoperative viscoelastic residue [22], or pre-existing open-angle glaucoma [23]. There was no significant difference between the two groups (P > 0.05, Table 1). The change in IOP in the V4 group was higher than that in the v4C group (P > 0.05) after PPV, and there were certain cases with high intraocular pressure symptoms. Further analysis showed that the arch height (idealized range, 250–850 µm) for patients with high IOP symptoms was smaller than that measured preoperatively (Fig. 2, B). After relieving the spasm of the ciliary muscle with compound tropicamide eye drops, the arch height was measured again, and it fell within the preoperative ideal range (Fig. 2, C,D). The IOP was returned to normal. Therefore, we concluded that the cause of transient high IOP after PPV might have been the transient ciliary spasm caused by the added pressure on the pars plana of the ciliary body after PPV (where the arch height becomes smaller, and the pupil block factor occurs in the peripheral iris) and ICL attachment. Compound tropicamide eye drops can alleviate ciliary spasm, deepen the anterior chamber, relieve the pupil block factor, promote aqueous humor circulation, and reduce IOP. In the v4C group, the “central flow technique” design reduced the risk of pupil block caused by cyclospasm (Fig. 3, A,B); therefore, there was no case of reduced arch height and high IOP. Mansoori et al.[23] presented a case of high IOP secondary to PPV, after v4C ICL implantation was complicated by rhegmatogenous retinal detachment. The reason may be that inflammatory factors blocked the “central hole,” which is similar to pupil block. After active anti-inflammatory treatment, the IOP symptoms were relieved. In this study, the postoperative reactions of the patients were mild, and the above situation did not occur. Although the overall IOP levels of the two groups were higher postoperatively, they were within the controllable range and were considered to be related to the application of hormones after the operation.

There were some limitations in this study. There was limited data regarding the included samples; hence, further large-sample, multi-center studies are recommended. In conclusion, this study showed that for patients with V4 ICL implantation and mesh removal, the stimulation of the ciliary body should be reduced as much as possible during PPV, and the risk factors for pupil block caused by ciliary muscle spasm should be reduced. If postoperative complications such as decreased arch height and increased intraocular pressure occur, the application of compound tropicamide eye drops is an effective method for initiating pupil movement.

BCVA, best corrected visual acuity; ICL, implantable contact lenses; IOL, intraocular lens implantation; IOP, intraocular pressure; OCT, optical coherence tomography; PPV, pars plana vitrectomy; UCVA, uncorrected visual acuity.

Acknowledgements

Not applicable.

Authors' contributions

Jian-Hai Bai, Xiao-Xiao Ruan, Yu-Zhang, Xiao-Min Ding, Xing-Zhi Yang analyzed and interpreted the patient data regarding the hematological disease and the transplant. Jin-Tao Chen performed the histological examination of the kidney, and was a major contributor in writing the manuscript. All authors read and approved the final manuscript.

Funding

No funding was received to assist with the preparation of this manuscript.

Availability data and materials

Data supporting the results reported in the article are not public but can be accessed after communicating with the corresponding author.

Ethics approval and consent to participate

The Ethics committee of Taizhou Central Hospital approved the clinical observations to meet ethical requirements (2021L-03-18). The written informed consents were obtained from patient of the subjects following detailed explanation of the nature and possible consequences of the study.

Consent for publication

A copy of the written consents is available for review by the editors of this journal.

Competing interests

The authors have no conflicts of interest to declare that are relevant to the content of this article.

Authors' information (optional)

¹Department of Ophthalmology,Taizhou Central Hospital (Taizhou University Hospital), 999 Donghaidadao St, Jiaojiangqu District, Taizhou, Zhejiang Province, 318000, China.

² Center for Surgery, Taizhou Central Hospital (Taizhou University Hospital), 999 Donghaidadao St, Jiaojiangqu District, Taizhou, Zhejiang Province, 318000, China.

³ Department of Ophthalmology, Taizhou Municipal Hospital, 381Zhongshandonglu St, Jiaojiangqu District, Taizhou, Zhejiang Province, 318000, China.

Santhiago MR. Percent tissue altered and corneal ectasia. Curr Opin Ophthalmol 2016; 27:311–315.
Alfonso JF, Lisa C, Alfonso-Bartolozzi B, et al. Collagen copolymer toric phakic intraocular lens for myopic astigmatism: one-year follow-up. J Cataract Refract Surg. 2014; 40(7):1155 ± 1162.
Lim DH, Lee MG, Chung ES, et al. Clinical results of posterior chamber phakic intraocular lens implantation in eyes with low anterior chamber depth. Am J Ophthalmol. 2014; 158(3):447 ± 454 e441.
Hashem AN, El Danasoury AM, Anwar HM. Axis alignment and rotational stability after implantation of the toric implantable collamer lens for myopic astigmatism. J Refract Surg. 2009; 25(10 Suppl):S939 ± 943.
Park SC, Kwun YK, Chung ES, et al. Postoperative astigmatism and axis stability after implantation of the STAAR Toric Implantable Collamer Lens. J Refract Surg. 2009; 25(5):403 ± 409.
Choi SH, Lee MO, Chung ES, et al. Comparison of the toric implantable collamer lens and bioptics for myopic astigmatism. J Refract Surg. 2011; 27(2):91 ± 97.
Bylsma SS, Zalta AH, Foley E, et al. Phakic posterior chamber intraocular lens pupillary block. J Cataract Refract Surg. 2002; 28(12):2222 ± 2228.
Pan CW, Ramamurthy D, Saw SM. Worldwide prevalence and risk factors for myopia. Ophthalmic Physiol Opt 2012;32:3–16.
Xu L, Li J, Cui T, et al. Refractive error in urban and rural adult Chinese in Beijing. Ophthalmology 2005;112:1676–83.
He M, Zeng J, Liu Y, et al. Refractive error and visual impairment in urban children in southern China. Invest Ophthalmol Vis Sci 2004;45:793–9.
Dolgin E. The myopia boom. Nature 2015;519:276–8.
Zhu ZC, Zhan X. Research progress of fundus changes in high myopia. Practical anti blindness Technology. 2016,11(04):181–184.
Green JS, Bear JC, Johnson GJ. The burden of genetically determined eye disease. Br J Ophthalmol 1986;70:696–9.
Krumpaszky HG, Ludtke R, Mickler A, et al. Blindness incidence in Germany. A population-based study from Wurttemberg-Hohenzollern. Ophthalmologica 1999; 213:176–82.
Munier A, Gunning T, Kenny D, et al. Causes of blindness in the adult population of the Republic of Ireland. Br J Ophthalmol 1998;82: 630–3.
Huseynova T, Ozaki S, Ishizuka T, et al. Comparative study of 2 types of implantable collamer lenses, 1with and 1 without a central artificial hole. Am J Ophthalmol 2014;157:1136–43.
Gabrielle Lapeyre, MD, Marie-Noelle Delyfer, MD, David Touboul, MD. Retinal detachment after acute posterior vitreous detachment resulting from posterior chamber phakic intraocular lens implantation. J Cataract Refract Surg 2018; 44:103–105.
Bylsma SS, Zalta AH, Foley E, et al. Phakic posterior chamber intraocular lens pupillary block. J Cataract Refract Surg. 2002; 28:2222–2228.
Kodjikian L, Gain P, Donate D, et al. Malignant glaucoma induced by a phakic posterior chamber intraocular lens for myopia. J Cataract Refract Surg.2002; 28:2217–2221.
Zaldivar R, Davidorf JM, Oscherow S. Posterior chamber phakic intraocular lens for myopia of – 8 to – 19 diopters. J Refract Surg. 1998; 14:294–305.
Almalki S, Abubaker A, Alsabaani NA, et al. Causes of elevated intraocular pressure following implantation of phakic intraocular lenses for myopia. Int Ophthalmol.2016; 36:259–265.
Senthil S, Choudhari NS, Vaddavalli PK,et al. Etiology and management of raised intraocular pressure following posterior chamber phakic intraocular lens implantation in myopic eyes. PLoS ONE. 2016; 17(11):e0165469.
Mansoori T, Agraharam SG. Reverse Pupillary Block After Retinal Detachment Surgery in an Eye with Toric Implantable Collamer Lens. Int Ophthalmol.2019; V39N3:703–710

No competing interests reported.

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Effectivity of V4 and v4C implantable contact lenses in the treatment of complications after vitreoretinal surgery: A comparative study

Status:

Version 1

Abstract

Objective

Methods

Results

Conclusion

Figures

Background

Methods

Patients

Comparison of preoperative and postoperative parameters

Pars plana vitrectomy

Data processing

Results

Comparison of uncorrected and best corrected visual acuity between the two groups

Comparison of intraocular pressures between the two groups

Comparison of the corneal endothelial count between the two groups

Comparison of arch height between the two groups

Comparison of the recurrence rate of retinal detachment between the two groups

Discussion

Abbreviations

Declarations

References

Additional Declarations

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