A Pilot Clinical Study of Complex Rhegmatogenous Retinal Detachment Treatment Via Foldable Capsular Buckle Scleral Buckling

doi:10.21203/rs.3.rs-1308075/v1

Download PDF

Research Article

A Pilot Clinical Study of Complex Rhegmatogenous Retinal Detachment Treatment Via Foldable Capsular Buckle Scleral Buckling

https://doi.org/10.21203/rs.3.rs-1308075/v1

This work is licensed under a CC BY 4.0 License

Version 1

posted

You are reading this older preprint version

Read the latest preprint version →

Purpose: To evaluate the feasibility of and identify problems in treating complex rhegmatogenous retinal detachment using foldable capsular buckle scleral buckling.

Methods: This prospective clinical study enrolled five patients with complex rhegmatogenous retinal detachment who were treated with foldable capsular buckle scleral buckling at the 988th Hospital of People’s Liberation Army Joint Logistic Force, China. During the 24-week follow-up period, the patients underwent measurements of their best-corrected visual acuity, slit-lamp examination, indirect ophthalmoscopy, and visual field testing. Additionally, B-ultrasound and fundus photography of the patients’ retinal reattachments helped evaluate the treatment’s post-surgery efficacy. We determined the safety of foldable capsular buckle scleral buckling based on the occurrence of infection, eye pain, diplopia, elevated intraocular pressure, and other serious postoperative complications.

Results: The complex rhegmatogenous retinal detachments of all five patients were successfully treated and evaluated via B-ultrasound and fundus photography after surgery. Visual acuity was enhanced in four patients 24 weeks after surgery, while the remaining patients developed diplopia after surgery. No other complications were observed.

Conclusion: This pilot study preliminarily determined that foldable capsular buckle scleral buckling is a feasible treatment for the efficient and safe treatment of complex rhegmatogenous retinal detachment. These results support this surgery as a potential and novel alternative to current extraocular procedures for the treatment of complex rhegmatogenous retinal detachment.

foldable capsular buckle

rhegmatogenous retinal detachment

scleral buckling

pars plana vitrectomy

foldable capsular vitreous body

Rhegmatogenous retinal detachment (RRD) is the most common form of retinal detachment. It is caused by a retinal ‘break’ that allows the ingress of fluid from the vitreous cavity to the subretinal space, resulting in retinal separation [1, 2]. RRD is clinically classified as simple or complex detachment. In simple RRD, retinal detachment is localized to a single, small retinal tear or hole at the retinal periphery, accompanied by good visibility of the fundus [3, 4]. However, in complex RRD, the detachment is partial, subtotal, or total, with a large retinal tear, multiple retinal breaks, posterior breaks, potential associations with vitreous hemorrhage, proliferative vitreoretinopathy (PVR), or other fundus diseases [3–5]. Currently, pars plana vitrectomy (PPV) is the most suitable surgery for complex RRD [3, 6–10]. However, PPV has several disadvantages, including acceleration of the development of cataracts in phakic eyes, increased risk of PVR and epiretinal membranes, low oxygen distribution in the vitreous, and higher cost [11–17]. Therefore, surgery can that effectively treat complex RRD is still under investigation.

In a previous preliminary study, we tentatively used foldable capsular buckle (FCB) external buckling to treat simple RRD in five patients and all retinas were reattached with few complications [18]. Compared with traditional external surgery, from the perspective of surgical principles, this surgery is less invasive, easier to perform, has fewer postoperative complications, and is less painful for patients. FCB is a commercially available product that is modified from foldable capsular vitreous bodies (FCVB) and is designed for scleral buckling to treat simple RRD [19]. The FCVB is made of silicone rubber and consists of a thin capsule with a tube-valve system, wherein the medium can be injected into the capsule [20]. Currently, a multi-center clinical study investigating RRD treatment via FCB scleral buckling is in progress. However, RRD treatment with FCB scleral buckling has only been used for simple RRD [18], and this technique has not previously been used to treat complex RRD.

We suggest that FCB scleral buckling combined with other adjuvant therapies, such as retinal photocoagulation, transscleral cryotherapy, and vitreous gas injection, may be suitable for the treatment of partial complex RRD for several reasons. First, because FCB scleral buckling can generate a larger buckling area on the sclera, it may be better to treat RRD with extensive retinal detachment or adjacent multiple retinal breaks. Second, compared with traditional scleral buckling, FCB may be easier to implant and place relatively posteriorly, making this surgery more suitable for patients with RRD with retinal breaks in the posterior region of the eye. Third, because the FCB generates spherical pressure, the pressure ridge is relatively smooth, which can reduce the effect of retinal surface tension and enhance retinal reattachment. Although our previous experiments aimed at treating simple RRD, successful retinal attachment and fewer postoperative complications led us to speculate that FCB scleral buckling could be a less invasive and simpler approach to treating some cases of complex RRD [18].

In this study, we tentatively used FCB to treat complex RRD patients who refused PPV surgery for various reasons. Through this pilot clinical study, we aimed to evaluate the feasibility of using FCB scleral buckling to treat complex RRD, identify problems that may arise during treatment, and lay the foundation for further research on FCB scleral buckling.

Ethics approval

The prospective observational clinical study protocol was reviewed and approved by the Institutional Review Board and Ethics Committee of the 988th Hospital of People’s Liberation Army Joint Logistic Force, China (9882019000), and adhered strictly to the principles of the World Medical Association’s (WMA) Declaration of Helsinki of the World Medical Association. All patients were provided with an explanation of the purpose and design of the study, and they were informed that FCB scleral buckling is still an off-label treatment for RRD. The patients provided written informed consent prior to participating in the study.

Subjects

This was a prospective study, and the patient inclusion criteria were as follows: to start, the patients had to have retinal detachments caused by one giant retinal tear or multiple retinal breaks that subtended less than 6 mm in their longest dimension, or had RRD associated with pseudophakia, high myopia, vitreous hemorrhage, PVR, or other fundus diseases. Some patients were not candidates for PPV surgery for various reasons. The exclusion criteria were patients who were allergic to silica, had severe systemic disease, were intolerant of surgery, or had previously received other surgical treatments, including PPV, scleral buckling, or pneumatic retinopexy.

FCB scleral buckling and surgical procedure

We followed a previously published surgical method without implementing significant changes [18].

Post-operative observation

To evaluate the efficacy of FCB scleral buckling on retinal reattachment, we performed B-ultrasound, optical coherence tomography, and fundus photography 1 week postoperatively (P1W). The main postoperative outcome was anatomical restoration of the retina at 24 weeks postoperatively (P24W). Additionally, the postoperative observation included best-corrected visual acuity (BCVA) (LogMAR) and recording of complications at 1 week, 2 weeks, 3 weeks, 4 weeks, 12 weeks, and 24 weeks post-surgery. The safety of the treatment was evaluated based on infection, eye pain, diplopia, elevated intraocular pressure (IOP), and other serious postoperative complications at 24 weeks after surgery.

All the clinical characteristics and surgical outcomes are summarized in Table 1.

Table 1

Clinical characteristics and surgical outcomes of the study subjects
Variables	Patient 1	Patient 2	Patient 3	Patient 4	Patient 5
Gender	Male	Female	Male	Male	Female
Age (years)	48	41	54	42	21
Onset of symptoms to the time of surgery (days)	10	2	3	4	30
Initial IOP (mmHg)	9	12	17	13	12
Eye axis (mm)	27.12	26.21	25.84	23.49	25.78
Other oculopathy	High myopia and posterior staphyloma	None	None	Pseudophakic eye	Proliferative vitreoretinopathy
Reason for refusing PPV	Surgery effect concern	Pregnant	Discomfort	Discomfort	Surgery effect concern
Initial BCVA	20/40	HM^*	20/100	20/200	20/50
Hole location	Superotemporal	Superotemporal	Superotemporal	Temporal	Lower
Retinal involvement scope	2 quadrants	2 quadrants	2 quadrants	2 quadrants	2 quadrants
Macula affected	No	Yes	Yes	Yes	Yes
Intraoperative treatment	Condensation	None	Condensation	Condensation	Condensation
Post-operative treatment	Photocoagulation	Photocoagulation	Photocoagulation	Photocoagulation	Photocoagulation
BCVA at 1 week post-operation	20/40	20/80	20/80	20/50	20/50
BCVA at 24 weeks post-operation	20/25	20/40	20/32	20/32	20/40
Other adjuvant treatments	Daily injections of 250 ml 20% mannitol and 40 mg methylprednisolone sodium succinate	Intravitreal gas injection on tenth post-operative day	Released a small amount of fluid from the FCB	None	None
Discomfort and complications after surgery	Foreign body sensation and eye pain until the day after surgery	Subretinal fluid	Diplopia	None	None
^*HM: Hand motion

In total, five patients were included in the study (three men and two women) with a mean age of 41.2 years (range: 21–52 years). The mean time from when the patients experienced a symptom of RRD to when they received surgery was 9.8 days (range: 2–30 days). The mean initial IOP was 12.6 mmHg (range: 9–17 mmHg) and the mean eye axis was 25.688 mm (range: 23.49–27.12 mm). The main reasons for refusing PPV included surgery effect concerns, meaning the patients were not satisfied with the effect of PPV on their contralateral eye, previous surgery, or they were encouraged by the better surgical outcomes of other subjects (2/5), pregnancy (1/5), or discomfort with PPV surgery (2/5).

Evaluating the efficacy of FCB scleral buckling for complex RRD treatment

Three patients’ retinal holes were located in the superotemporal region, one was in the temporal retina, and one was in the lower retina. The retinal detachment of all five patients involved two quadrants, and only one patient’s macula was not affected. Four patients underwent intraoperative condensation, and all patients received postoperative photocoagulation. At 24 weeks post-operation (P24W), all patients had good retinal anatomical restoration. At 1 week post-operation (P1W), three patients had enhanced BCVA, and at P24W, all patients had enhanced BCVA. The retinal detachments and anatomical restorations of all five patients are shown in Figures 1–5.

Safety evaluation of FCB scleral buckling

In terms of safety, none of the five patients experienced adverse events, such as endophthalmitis, cardiovascular events, or other systemic reactions. There were no acute high IOP events caused by the FCB scleral buckling, nor were there episodes of severe postoperative bleeding or unbearable discomfort, as observed in the safety evaluation of a previous study [18]. However, it should be noted that Patient 3 developed diplopia after the operation and her eye movement was limited, which could have been a complication of FCB implantation affecting the lateral rectus. However, when the retina was reattached and the FCB was removed, her diplopia resolved, and the limitations of her eye movement were corrected. Additionally, Patient 1 had a foreign body sensation and eye pain, but on the second day post-surgery, it spontaneously remitted. Therefore, this study proved that FCB scleral buckling is safe.

This pilot clinical study preliminarily demonstrated that FCB scleral buckling is a feasible treatment alternative for retinal reattachment in some complex RRD cases when patients refuse PPV surgery. Considering a previous exploratory clinical study that used this technique to treat simple RRD, we suggest that FCB scleral buckling may represent an innovative surgical method to improve general RRD management [18].

From the postoperative examination results of five patients, it is clear that external FCB exerted pressure on the sclera and retina, and that its location was not easily changed by ocular movement during the postoperative observation period. Combined with subretinal fluid release, transscleral cryotherapy, and retinal photocoagulation, FCB scleral buckling surgery greatly improved the BCVA of the five patients compared to before surgery, indicating that this innovative surgical method supports retinal reattachment and restores function. The retina was successfully reattached after surgery in all the patients.

For Patient 2, postoperative examination showed a small amount of subretinal fluid in the upper peripheral fundus; therefore, we conducted intravitreal gas injection on the tenth postoperative day to promote close attachment of the retina. The second day after intravitreal gas injection, the retina was fully reattached. Postoperative OCT of Patient 5 showed that the neuroepithelial retina was still slightly detached, which may be due to the patient’s long period of retinal detachment, viscous subretinal fluid, and severe PVR proliferation cord. However, a relatively common scenario in patients who undergo retinal reattachment is the slow absorption of viscous subretinal fluid and full reattachment. Considering the severe retinal detachment in all five patients, combined with the special case of high myopia, intraocular lens, or PVR, we show that FCB scleral buckling is effective in the treatment of complex RRD.

None of the five patients experienced severe adverse events, such as endophthalmitis, cardiovascular events, or other systemic reactions. Moreover, there were no acute high IOP events caused by FCB scleral buckling, nor were there episodes of severe postoperative bleeding or extreme discomfort. However, it should be noted that Patient 3 developed diplopia after the operation, which did not resolve after fluid was released from the FCB, but continued until the FCB was removed. This may have occurred because the FCVB influenced the extraocular muscles, especially since it was located under the rectus in accordance with the patient’s retinal detachment and hole location. However, the complication was resolved by removing the FCVB, indicating that its influence on the extraocular muscles is reversible. Because the FCB balloon is not continuously implanted under the conjunctiva, diplopia may occur in some patients, but with the removal of the balloon, this issue will resolve. Therefore, with these few complications and using the 3/n rule, we are confident that the true complication rate of FCB scleral buckling is no more than 60% [21].

FCB scleral buckling is an improvement of traditional external scleral surgery, compared to which it might possess advantages and avoid some shortcomings. In external scleral surgery, the fundus image is inverted through an indirect ophthalmoscope and the magnification is small, making it difficult to perform and master. In addition, post-eyeball anesthesia is needed to increase the risk of puncturing the eyeball. Moreover, the sclera needs to be exposed by repeatedly pulling the muscle, thus inducing pain in the patient and introducing a high risk of the occurrence of the oculocardiac reflex. In contrast, in FCB scleral buckling, all these procedures are conducted under a microscope and involve fewer muscles, making it less invasive and easier to perform. Only Patient 2 in this study received local surface infiltration anesthesia, which may indicate that this surgery is especially suitable for the elderly, young children, nervous patients, patients in poor health, and even pregnant women.

This type of surgery also has a larger pressure range, usually covering the hole and surrounding the detached retina. Although the spherical pressure generated by the FCVB and its indwelling time can be controlled, we tentatively used FCB scleral buckling to treat some complex RRD patients, although these patients should have received PPV surgery but refused. As a type of external scleral surgery, FCB scleral buckling has the common advantages of external scleral surgery and could avoid some disadvantages of PPV surgery, such as increased risk of PVR and epiretinal membranes as well as low oxygen distribution in the vitreous, which could further accelerate cataracts in phakic eyes and damage trabecular meshwork cells [11–16]. FCB scleral buckling could also avoid optic nerve atrophy, disruption of ciliary body secretion induced by silicone oil injection, and other complications caused by PPV surgery [13, 22–29].

This study showed that FCB scleral buckling can be a feasible, effective, and safe alternative to retinal reattachment in some complex RRD cases when patients refuse PPV surgery. However, certain shortcomings of this surgery should not be neglected: it is relatively difficult to fix if the FCVB is located under the muscle, and patients with an FCVB are at risk of developing temporary diplopia, although this can be relieved by releasing some water from the balloon. Additionally, the current study design has some limitations, notably a small number of subjects, lack of a control group, and no comparison with conventional treatment strategies. Accordingly, a large-scale randomized study controlled with PPV should be conducted to further confirm the efficacy and safety of FCB scleral buckling.

In summary, this study showed that FCB scleral buckling is a simple, easy to learn, less invasive, and less complicated alternative for treating some complex RRD cases when patients refuse PPV surgery. These promising results grant us the confidence to conduct large-scale multicenter clinical trials to further verify the efficacy and safety of FCB sclera buckling.

Acknowledgements

The authors are grateful to the 988th Hospital of the People’s Liberation Army Joint Logistic Force for supporting this study. Funding: The authors declare that no funds, grants, or other support were received during the preparation of this manuscript.

Author Contributions: All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by [Cheng Li] and [Baike Zhang]. The first draft of the manuscript was written by [Cheng Li] and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Conflicts of interest

The authors have no relevant financial or non-financial interests to disclose.

Steel D (2014) Retinal detachment. BMJ Clin Evid 2014:0710
Mitry D, Fleck BW, Wright AF, Campbell H, Charteris DG (2010) Pathogenesis of rhegmatogenous retinal detachment: predisposing anatomy and cell biology. Retina 30(10):1561–1572. https://doi.org/10.1097/IAE.0b013e3181f669e6
Lumi X, Lužnik Z, Petrovski G, Petrovski B, Hawlina M (2016) Anatomical success rate of pars plana vitrectomy for treatment of complex rhegmatogenous retinal detachment. BMC Ophthalmol 16(1):216. https://doi.org/10.1186/s12886-016-0390-2
Heimann H, Hellmich M, Bornfeld N, Bartz-Schmidt KU, Hilgers RD, Foerster MH (2001) Scleral buckling versus primary vitrectomy in rhegmatogenous retinal detachment (SPR Study): design issues and implications. SPR Study report no. 1. Graefes Arch Clin Exp Ophthalmol 239(8):567–574. https://doi.org/10.1007/s004170100319
Azen SP, Scott IU, Flynn HW Jr, Lai MY, Topping TM, Benati L et al (1998) Silicone oil in the repair of complex retinal detachments. A prospective observational multicenter study. Ophthalmology 105(9):1587–1597. https://doi.org/10.1016/S0161-6420(98)99023-6
Tosi GM, Balestrazzi A, Baiocchi S, Tarantello A, Cevenini G, Marigliani D, Simi F (2017) COMPLEX RETINAL DETACHMENT IN PHAKIC PATIENTS: Previtrectomy phacoemulsification versus combined Phacovitrectomy. Retina 37(4):630–636. https://doi.org/10.1097/IAE.0000000000001221
Schneider EW, Geraets RL, Johnson MW (2012) Pars plana vitrectomy without adjuvant procedures for repair of primary rhegmatogenous retinal detachment. Retina 32(2):213–219. https://doi.org/10.1097/IAE.0b013e3182278b29
Tseng JJ, Schiff WM, Barile GR, Biscette O, Williams SL, Cekic O et al (2009) Influence of postoperative lens status on intraocular pressure in proliferative vitreoretinopathy. Am J Ophthalmol 147(5):875–885 885.e1. https://doi.org/10.1016/j.ajo.2008.10.021
Caiado RR, Magalhães O Jr, Badaró E, Maia A, Novais EA, Stefanini FR et al (2015) Effect of lens status in the surgical success of 23-gauge primary vitrectomy for the management of rhegmatogenous retinal detachment: the Pan American Collaborative Retina Study (PACORES) group results. Retina 35(2):326–333. https://doi.org/10.1097/IAE.0000000000000307
Wong CW, Wong WL, Yeo IY, Loh BK, Wong EY, Wong DW et al (2014) Trends and factors related to outcomes for primary rhegmatogenous retinal detachment surgery in a large Asian tertiary eye center. Retina 34(4):684–692. https://doi.org/10.1097/IAE.0b013e3182a48900
Ryan EH Jr, Mittra RA (2010) Scleral buckling vs vitrectomy: the continued role for scleral buckling in the vitrectomy era. Arch Ophthalmol 128(9):1202–1205. https://doi.org/10.1001/archophthalmol.2010.192
Park SW, Lee JJ, Lee JE (2018) Scleral buckling in the management of rhegmatogenous retinal detachment: patient selection and perspectives. Clin Ophthalmol 12:1605–1615. https://doi.org/10.2147/OPTH.S153717
Heimann H, Bartz-Schmidt KU, Bornfeld N, Weiss C, Hilgers RD, Foerster MH, Scleral Buckling versus Primary Vitrectomy in Rhegmatogenous Retinal Detachment Study Group (2007) Scleral buckling versus primary vitrectomy in rhegmatogenous retinal detachment: a prospective randomized multicenter clinical study. Ophthalmology 114(12):2142–2154. https://doi.org/10.1016/j.ophtha.2007.09.013
Sharma YR, Karunanithi S, Azad RV, Vohra R, Pal N, Singh DV, Chandra P (2005) Functional and anatomic outcome of scleral buckling versus primary vitrectomy in pseudophakic retinal detachment. Acta ophthalmol Scand 83(3):293–297. https://doi.org/10.1111/j.1600-0420.2005.00461.x
Brazitikos PD, Androudi S, Christen WG, Stangos NT (2005) Primary pars plana vitrectomy versus scleral buckle surgery for the treatment of pseudophakic retinal detachment: a randomized clinical trial. Retina 25(8):957–964. https://doi.org/10.1097/00006982-200512000-00001
Campo RV, Sipperley JO, Sneed SR, Park DW, Dugel PU, Jacobsen J, Flindall RJ (1999) Pars plana vitrectomy without scleral buckle for pseudophakic retinal detachments. Ophthalmology 106(9):1811–1815 discussion 6. https://doi.org/10.1016/S0161-6420(99)90353-6
Beebe DC, Shui YB, Siegfried CJ, Holekamp NM, Bai F (2014) Preserve the (intraocular) environment: the importance of maintaining normal oxygen gradients in the eye. Jpn J Ophthalmol 58(3):225–231. https://doi.org/10.1007/s10384-014-0318-4
Zhang B, Li C, Jia Y, Li X, Guo L, Wang C, Tian X (2020) A pilot clinical study of treating rhegmatogenous retinal detachment by silicone rubber balloon scleral buckling. Retina 40(10):1918–1928. https://doi.org/10.1097/IAE.0000000000002685
Yang W, Yuan Y, Zong Y, Huang Z, Mai S, Li Y et al (2015) Preliminary study on retinal vascular and oxygen-related changes after long-term silicone oil and foldable capsular vitreous body tamponade. Sci rep :2014 Sci Rep 4(1). https://doi.org/10.1038/srep05272
Gao Q, Mou S, Ge J, To CH, Hui Y, Liu A et al (2008) A new strategy to replace the natural vitreous by a novel capsular artificial vitreous body with pressure-control valve. Eye (Lond Engl) 22(3):461–468. https://doi.org/10.1038/sj.eye.6702875
Schachat AP, Chambers WA, Liesegang TJ, Albert DA (2003) Safe and effective. Ophthalmology 110(11):2073–2074. https://doi.org/10.1016/S0161-6420(03)01004-2
Baillif S, Gastaud P (2014) Complications of silicone oil tamponade. J Fr Ophtalmol 37(3):259–265. https://doi.org/10.1016/j.jfo.2013.11.004
Gao QY, Fu Y, Hui YN (2015) Vitreous substitutes: challenges and directions. Int J Ophthalmol 8(3):437–440. https://doi.org/10.3980/j.issn.2222-3959.2015.03.01
Tavares RLP, Nóbrega MJ, Nóbrega FAJ, De Novelli FJ, De Oliveira CAC (2015) Timing and outcomes after silicone oil removal in proliferative vitreoretinopathy: a retrospective clinical series. Int J Retina Vitreous 1:2. https://doi.org/10.1186/s40942-015-0002-y
Shui YB, Holekamp NM, Kramer BC, Crowley JR, Wilkins MA, Chu F et al (2009) The gel state of the vitreous and ascorbate-dependent oxygen consumption: relationship to the etiology of nuclear cataracts. Arch Ophthalmol 127(4):475–482. https://doi.org/10.1001/archophthalmol.2008.621
Feng X, Li C, Zheng Q, Qian XG, Shao W, Li Y et al (2017) RISK OF SILICONE OIL AS vitreous tamponade IN PARS PLANA vitrectomy: A systematic review and meta-analysis. Retina 37(11):1989–2000. https://doi.org/10.1097/IAE.0000000000001553
Gao Q (2017) Know the vitreous metabolic function and intervene it cautiously. Chin J Ocul Fundus Dis 33:336–340
Schmidt I, Plange N, Rößler G, Schellhase H, Koutsonas A, Walter P, Mazinani B (2019) Long-term clinical results of vitrectomy and scleral buckling in treatment of rhegmatogenous retinal detachment. ScientificWorldJournal 2019:5416806. https://doi.org/10.1155/2019/5416806
Cankurtaran V, Citirik M, Simsek M, Tekin K, Teke MY (2017) Anatomical and functional outcomes of scleral buckling versus primary vitrectomy in pseudophakic retinal detachment. Bosn J Basic Med Sci 17(1):74–80. https://doi.org/10.17305/bjbms.2017.1560

Download PDF

Version 1

posted

You are reading this older preprint version

Read the latest preprint version →

A Pilot Clinical Study of Complex Rhegmatogenous Retinal Detachment Treatment Via Foldable Capsular Buckle Scleral Buckling

Archived Versions:

Version 1

Abstract

Figures

Introduction

Methods

Ethics approval

Subjects

FCB scleral buckling and surgical procedure

Post-operative observation

Results

Evaluating the efficacy of FCB scleral buckling for complex RRD treatment

Safety evaluation of FCB scleral buckling

Discussion

Declarations

References

Archived Versions:

Version 1