Clinical outcomes of complex rhegmatogenous retinal detachment treated with a 25-G, 10,000-cpm beveled-tip cutter probe
Introduction
Rhegmatogenous retinal detachment (RRD) is one of the most common vision-threatening entities (1). Pars plana vitrectomy (PPV), scleral buckle (SB), and pneumatic retinopexy are the main surgical methods used to treat RRD, of which, PPV has become increasingly popular, especially for complex conditions (2).
In 2002, Fujii first described 25-gauge (25-G) microincision vitreous surgery (MIVS) (3), and showed that MIVS increased the selectiveness and precision of vitrectomy, and reduced the operative time, suture-related complications, postoperative inflammation, and patient discomfort. As a result, it has since been widely used in clinical practice (4-6). Much effort has been exerted to improve the instrumentation of MIVS, especially the vitreous cutter probe (7). The recently launched 25-G, 10,000-cuts-per-minute (cpm) Advanced UltraVit® Beveled High-Speed Probe (Constellation® Vision System, Alcon Surgical, Irvine, CA, USA) is a beveled-tip cutter probe (BTCP) that has a larger port than the earlier generation 25-G probes, and was designed to work at a higher cutting speed of 10,000-cpm (8). The beveled-tip design reduces its tip-to-port distance to 0.009 inches, which is much smaller than the 0.017 inches of the flat-tip 25-G probe.
Theoretically, the new 10,000-cpm BTCP should achieve more thorough vitreous clearance, reduce retinal traction, and increase the vitreous flow rate and aspiration rate at the same level of vacuum. To date, only Uy et al. have reported encouraging clinical results using this new probe (8). However, additional data are required to determine the efficiency and safety of the probe, especially in complicated cases. In this study, we investigated a rather large series of eyes with complicated RRD to examine the safety and efficacy of the 25-G, 10,000-cpm BTCP. We present this article in accordance with the STROBE reporting checklist (available at https://qims.amegroups.com/article/view/10.21037/qims-24-1460/rc).
Methods
Eligibility
A single-center prospective study was conducted of 60 patients (60 eyes) who underwent primary PPV at the Eye and Ear, Nose, and Throat (ENT) Hospital of Fudan University (Shanghai, China) between March 12 and October 22, 2021. The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013). Informed consent was obtained from all the individual patients included in the study. The study protocol was approved by the Institutional Review Board of the Eye and ENT Hospital of Fudan University (No. 2021021).
Criteria
Patients were considered eligible for inclusion in the study if they met the following inclusion criteria: (I) had primary complex RRD with a giant retinal tear or multiple retinal breaks involving more than one quadrant, or a macular hole (MH); (II) had primary complex RRD with choroidal detachment; or (III) had primary complex RRD with proliferative vitreoretinopathy (PVR) grade C (9,10). Patients were excluded from the study if they met any of the following criteria: (I) had a history of ocular trauma; (II) had any intraocular surgical history other than cataract surgery; and/or (III) had a history of intraocular disease other than cataract. The level of PVR was graded according to the updated Retina Society Classification of 1991 (11).
Clinical information collection
All the patients underwent preoperative and postoperative ophthalmological examinations, including the best-corrected visual acuity (BCVA) test, dilated indirect slit-lamp biomicroscopy examination, intraocular pressure (IOP) test using a non-contact tonometer (Nidek NT400, Nidek Co., Ltd., Aichi, Japan), corneal endothelial cell density count using a non-contact specular microscope (Topcon America Corporation, Paramus, NJ, USA), and axial length (AL) measurement using the IOLMaster 700 (version 3.01; Carl Zeiss Meditec, Jena, Germany). The age, sex, ophthalmic history, macular status, extent of retinal detachment, number of breaks, and days between the visual loss and surgery of each patient were also recorded.
Surgery
All the surgeries were performed by a single surgeon (C.J.). The patients received a local retrobulbar anesthetic or general anesthesia, and the eye was prepared and draped in the standard ophthalmic procedure. If necessary, phacoemulsification was performed first. PPV was performed using the 25-G, 10,000-cpm BTCP (25-G Advanced UltraVit®, Constellation® Vision System, Alcon Surgical). A wide-angle viewing system (Resight 700, Zeiss Meditec) and high-magnification contact lens provided surgical visualization. PPV began with core vitrectomy. The central vitreous was removed using the core vitrectomy setting (proportional cutting; infusion pressure: 25 mmHg, maximum vacuum: 600 mmHg; cut rate: 10,000-cpm). After core vitrectomy, triamcinolone acetonide was routinely injected to visualize the posterior vitreous cortex. Posterior vitreous detachment was induced (if not present). Perfluorocarbon liquid was injected to stabilize the posterior retina. The vitreous base was then meticulously shaved circumferentially with scleral depression. After fluid-air exchange, endolaser photocoagulation was performed to treat any detected retinal tears (except MHs) or suspicious lesions. Silicone oil or air was used for the tamponade.
Surgery information collection
The duration of retinal detachment was defined as the time between the initial presentation of symptoms and the operation. The efficiency of the probe was primarily evaluated by the following temporal indicators during the operation: the total surgical time (i.e., the time from the insertion of the first trocar to the removal of the last trocar); the core vitrectomy time (i.e., the time from vitrectomy to the injection of triamcinolone acetonide); and the peripheral vitreous shaving time (i.e., the scleral depression time from start to finish). Iatrogenic retinal breaks and other complications that occurred during the procedure and/or the follow-up period were recorded, and used to determine the safety of the probe. The number of surgical steps comprised the number of maneuvers executed, including phacoemulsification, intraocular lens (IOL) implantation or removal, vitrectomy, injection of perfluorocarbon liquid, membrane peeling, retinotomy, fluid-air exchange, laser, scleral cryotherapy, injection of silicone oil, and the placement of an encircling band.
Statistical analysis
BCVA was converted to the logarithm of the minimum angle of resolution (logMAR). The continuous data are described as the mean ± standard deviation. The categorical data are described as the absolute or relative frequency in each category. The Kolmogorov-Smirnov test was used for the normal distribution test. An unpaired t-test and non-parametric statistical tests (i.e., the Wilcoxon test, χ2 test, and Spearman’s test) were used to analyze the differences between groups. Univariate and multivariate analyses were conducted to identify the factors associated with the total duration of surgery and the final BCVA. P values of <0.05 were considered statistically significant. SPSS for Windows version 17.0 (SPSS Inc., Chicago, IL, USA) was used for all the statistical analyses.
Results
In total, 60 eyes (35 right eyes) of 60 patients (25 female) were included in the study. The mean age of the patients was 50.23±15.22 years, and the mean duration of retinal detachment was 2.50 (1.43, 8) weeks. The mean preoperative BCVA was 1.55±0.62 logMAR, the mean IOP was 13.01±4.50 mmHg, and the mean AL was 25.36±2.54 mm. All 60 eyes had complex RRD and underwent PPV for retinal reattachment. Of the 60 eyes, 6 (10.00%) had RRD with a giant retinal tear (Figure 1), 15 (25.00%) had RRD with multiple retinal breaks involving more than one quadrant, 12 (20.00%) had MHs, 14 (23.33%) had combined choroidal detachment, and 32 (53.33%) had PVR grade C. Seventeen eyes (28.33%) had two or more of these conditions. The mean area of retinal detachment was 8.01±3.54 clock hours, and the macula was attached in eight eyes and detached in 52 eyes (Table S1).
![Click on image to zoom](http://cdn.amegroups.cn/journals/amepc/files/journals/4/articles/133481/public/133481-PB5-4978-R1.jpg/w300)
PPV was performed under peribulbar anesthesia in 50 patients and under general anesthesia in 10 patients. The average number of surgical steps was 5.22±1.17 steps. Phacovitrectomy without IOL implantation was performed in 34 eyes, a combined encircling band was placed in four eyes, an IOL was removed from two eyes, and retinotomy was performed in five eyes. The mean total surgical time was 59.22±14.85 min, the mean core vitrectomy time was 0.99±0.25 min, and the mean peripheral vitreous shaving time was 22.02±9.69 min. Iatrogenic retinal breaks occurred in 15 eyes, of which, nine occurred during the shaving of the peripheral vitreous base, three occurred during the extension of the posterior vitreous detachment to the periphery, and three occurred when the PVR membrane was peeled with forceps. At the end of the procedure, silicone oil was injected in 55 eyes, while air was used in five eyes (Table S2).
During the follow-up period, retinal re-detachment occurred in five eyes treated with silicone oil, and in one eye treated with air tamponade. Retinal re-detachment was treated using repeated vitrectomy and silicone oil tamponade. IOP was elevated in 19 eyes, four of which were implanted with a pressure-relief valve, and the remaining 15 of which were successfully managed using topical medication. Forty-three patients underwent silicone oil removal. Of these 43 patients, six also underwent IOL implantation, four also underwent combined phacoemulsification and IOL implantation, and eight also underwent membrane peeling, laser supplementation, or gas-liquid exchange (Table S3).
There was no loss to follow-up during the study. All 60 subjects underwent surgery and completed more than 3 months of postoperative follow-up. After an average follow-up period of 6.31±2.24 months, the retina was attached in all 60 eyes (13 of which still contained silicone oil). Of the 60 eyes, 21 eyes were phakic, 10 were pseudophakic, and 29 were aphakic. The average final BCVA was 0.99±0.54 logMAR, which was significantly better than the preoperative value (P<0.001). The mean IOP was 17.48±6.06 mmHg (Table S3).
Eyes with iatrogenic breaks had a longer total surgical time (71.00±20.99 vs. 55.29±9.60 min in eyes without breaks, P=0.01), a longer peripheral shaving time (28.87±13.97 vs. 19.74±6.52 min, respectively, P=0.03), a longer core vitrectomy time (1.18±0.35 vs. 0.92±0.16 min, respectively, P=0.01), and worse initial BCVA (1.82±0.49 vs. 1.47±0.65 logMAR, respectively, P=0.07). However, all the other clinical factors were similar in the two groups (Table 1). The following learning curve was also observed: in the first 20 eyes, the incidence of iatrogenic breaks was 35%, decreasing to 25% in the next 20 eyes, and to 15% in the last 20 eyes. A multivariate analysis showed that the degree of PVR was the only parameter correlated with the total surgical time (P<0.05; Table 2). The final BCVA was associated with the duration of retinal detachment, the preoperative BCVA, macular involvement, and the presence of a MH (Table 3).
Table 1
Factors | Iatrogenic retinal break | P value | |
---|---|---|---|
No (n=45) | Yes (n=15) | ||
Age (years) | 51.33±12.55 | 45.93±21.59 | 0.46 |
Gender (male/female) | 25/20 | 10/5 | 0.45 |
Disease course (weeks) | 4 [1.43, 4] | 2 [1.43, 24] | 0.94 |
BCVA at initial visit (logMAR) | 1.47±0.65 | 1.82±0.49 | 0.07 |
IOP at initial visit (mmHg) | 13.17±4.89 | 12.55±3.17 | 0.65 |
AL (mm) | 25.12±2.04 | 26.08±3.60 | 0.34 |
Status of macular (on/off) | 8/37 | 0/15 | 0.08 |
MH (yes/no) | 10/35 | 1/14 | 0.18 |
PVR (grade B/C) | 24/21 | 4/11 | 0.08 |
RRD extent (clock hours) | 7.64±3.39 | 9.13±3.87 | 0.20 |
Chroidal detachment (yes/no) | 10/35 | 4/11 | 0.73 |
Total surgical time (min) | 55.29±9.60 | 71.00±20.99 | 0.01 |
Core vitrectomy time (min) | 0.92±0.16 | 1.18±0.35 | 0.01 |
Periphery shaving time (min) | 19.74±6.52 | 28.87±13.97 | 0.03 |
Surgery steps | 5.11±1.23 | 5.53±0.92 | 0.17 |
Retinal detachment post-primary vitrectomy (detach/attach) | 4/41 | 2/13 | 0.23 |
Data are presented as the mean ± standard deviation, number, median [P25, P75]. BCVA, best correct visual acuity; logMAR, logarithm of the minimum angle of resolution; IOP, intraocular pressure; AL, axial length; MH, macular hole; PVR, proliferative vitreoretinopathy; RRD, rhegmatogenous retinal detachment.
Table 2
Characteristics | P value | |
---|---|---|
Univariate analysis (age- and sex-adjusted) |
Multivariate analysis | |
Age (years) | 0.07 | – |
Gender | 0.22 | – |
Disease course (weeks) | 0.34 | – |
BCVA at initial visit (logMAR) | 0.14 | – |
IOP at initial visit (mmHg) | 0.90 | – |
AL (mm) | 0.43 | – |
Macular involvement | 0.21 | – |
MH | 0.71 | – |
PVR (grades) | 0.02 | 0.02 |
Surgery steps | 0.04 | 0.72 |
Choroidal detachment | 0.72 | – |
RRD extent (clock hours) | 0.21 | – |
BCVA, best correct visual acuity; logMAR, logarithm of the minimum angle of resolution; IOP, intraocular pressure; AL, axial length; MH, macular hole; PVR, proliferative vitreoretinopathy; RRD, rhegmatogenous retinal detachment.
Table 3
Characteristics | P value | |
---|---|---|
Univariate analysis (age- and sex-adjusted) |
Multivariate analysis | |
Age (years) | 0.27 | – |
Gender | 0.25 | – |
Disease course (weeks) | <0.01 | 0.03 |
BCVA at initial visit (logMAR) | <0.001 | 0.048 |
IOP at initial visit (mmHg) | 0.28 | – |
AL (mm) | 0.70 | – |
Macular involvement | <0.01 | 0.03 |
MH | <0.01 | <0.01 |
PVR grade | 0.14 | – |
Surgery steps | <0.001 | 0.54 |
Choroidal detachment | 0.53 | – |
Re-detachment | 0.10 | – |
IOP at last visit (mmHg) | 0.99 | – |
Iatrogenic retinal break | 0.04 | 0.17 |
Total surgical time (min) | 0.03 | 0.26 |
RRD extent (clock hours) | 0.02 | 0.97 |
BCVA, best correct visual acuity; logMAR, logarithm of the minimum angle of resolution; IOP, intraocular pressure; AL, axial length; MH, macular hole; PVR, proliferative vitreoretinopathy; RRD, rhegmatogenous retinal detachment.
Discussion
To our knowledge, this was the first study to examine the clinical usage and outcome of 25-G, 10,000-cpm BTCP in a relatively large group of patients with complex RRD. Of the 60 eyes with complex RRD, 10.00% had RRD with a giant retinal tear, 25.00% had RRD with multiple retinal breaks involving more than one quadrant, 20.00% had MHs, 23.33% had combined choroidal detachment, 53.33% had PVR grade C, and 28.33% had more than one of these complex factors. After an average follow-up period of at least 6 months, the retina had re-attached in all eyes, and the BCVA had also improved.
The new 10,000-cpm BTCP has many advantages, including a high cutting speed. Abulon et al. developed a porcine ocular model to calculate the traction force applied to the retina during vitrectomy, and showed that retinal traction decreases as the cutting rate increases (12). Research has also shown that a high cutting speed increases vitreous fragmentation, reduces viscosity, and lowers the resistance to flow, thus increasing the vitreous flow rate (4).
The new cutter also has a larger port than the standard 25-G probe. Previous research has shown that the port size also affects retinal traction, and a small port size requires larger elastic deformation if the tissue is to enter the port along the transport pressure gradient, while a higher pressure can lead to a temporary fluid surge and increased traction (13). Additionally, a larger probe allows for more accurate fluidic control, which is equally critical in reducing retinal traction during vitrectomy, and enabling more thorough vitreous clearance during surgery (13). Therefore, the larger port size not only increases the efficiency of the maneuver but also reduces the retinal traction, making vitrectomy safer (4).
Further, the beveled design reduces the tip-to-port distance, which facilitates the removal of the vitreous (12). It has also been shown that compared to flat-tip cutters, beveled-tip cutters aspirate the frontal and proximal flows at a greater velocity, generating higher and more constant aspiration rates at the same level of vacuum (8,14). Overall, the 10,000-cpm BTCP was designed to facilitate more thorough vitreous removal both efficiently and safely.
At the last follow-up, BCVA was improved in all patients, and the retina was anatomically attached in all eyes, which may be due to the thorough removal of the vitreous. Vitrectomy is used to treat RRD by relieving the traction and sealing the breaks (15-18). The complete removal of the vitreous not only relieves the vitreous traction, but also reduces the possibility of PVR, which can occur postoperatively. Further, extensive vitreous removal may allow any retinal breaks that were undetectable before surgery to be identified and managed, which can also affect surgical success. Several studies have shown that the thorough removal of the vitreous results in better anatomical and visual outcomes (15-18).
A reduced tip-to-port distance allows the port to get closer to the retina. Further, by beveling the tip on the port side facing the retina, the vitreous can be shaved even more closely (8,12). The thorough clearing of the vitreous, which relieves the traction and minimizes any further development of PVR on the substrate, could be one reason for the high anatomical success rate of this study. Teixeira et al. reported that small-gauge PPV achieved good outcomes without shaving the vitreous base under scleral depression (19). However, it should be noted that in their patients, adjunct SB was performed in 34% of the eyes. Conversely, in the present study, it was performed in only 4 eyes (6.67%). The rationale behind both shaving the peripheral vitreous and SB is to relieve the peripheral traction, and the favorable results of both Teixeira et al.’s study and our study suggest that both techniques can achieve satisfactory results (19).
Many of the features of the new probe were designed to reduce the retinal traction and the occurrence of iatrogenic retinal breaks. The incidence of iatrogenic breaks in the present study was 25%, which is similar to that reported in previous studies (20-22). The new probe does not appear to offer any advantage in this regard; however, this may be because all of our patients suffered from complicated RRD, requiring the complete shaving of the peripheral vitreous. It has been reported that the very thorough removal of the vitreous is accompanied by a high rate of iatrogenic holes (20-22). In the present study, 60% of the iatrogenic retinal breaks occurred during the shaving of the vitreous base. The peripheral vitreous shaving time was longer in eyes with iatrogenic breaks (28.87±13.97) than eyes without breaks (19.74±6.52 min, P=0.03). However, the incidence of iatrogenic breaks decreased over the course of the study; from 35% in the first 20 eyes to 25% in the middle 20 eyes, and to only 15% in the last 20 eyes. This may be partly attributable to a learning curve.
Moreover, all vitrectomies were performed using the proportional cutting mode, with the maximum vacuum set to 600 mmHg throughout the procedure in the early cases. In the later cases, peripheral vitreous shaving was performed under a maximum vacuum of only 300 mmHg. The rationale behind this was that shaving does not require a high vacuum. With the proportional cutting mode, the vacuum can be controlled using a foot pedal, allowing the vacuum range to be reduced from 0–600 to 0–300 mmHg, resulting in more precise vacuum control. The safe vacuum range (which was defined as the vacuum remaining within the optimal range) of the foot pedal was relatively large. A larger safe range may be important in difficult cases, for which operations are usually longer, or may become important if the surgeon begins to experience fatigue after performing several operations. Iatrogenic retinal breaks occurred during vitrectomy; however, the retina had re-attached in all eyes by the final follow-up, and our analysis showed that the final BCVA was not related to the occurrence of iatrogenic holes, which is consistent with other reports (20-22).
The total duration of surgery was 59.22±14.85 min in our study. One of the main concerns or perceived drawbacks of the 25-G probe is that the fluid flow rates are expected to decrease as the surgical time increases. In the present study, the total duration of surgery fell within the range (34.1–71.3 min) reported in previous studies that used larger-gauge probes (20- or 23-G) (21,22). The mean vitrectomy time (i.e., the core vitrectomy time + the periphery shaving time) was 23.01±9.90 min, and was similar to the vitrectomy times reported for 20- or 23-G probes (16.00–30.75 min) (23,24). Given the complexity of our cases, the equivalent surgical times suggest that the efficiency of this 10,000-cpm BTCP is good.
Further, the final BCVA was found to be correlated with the duration of retinal detachment, the preoperative BCVA, and macular involvement. This provides further evidence that RRD should be treated as an emergency. The average number of surgical steps was 5.22±1.17 steps. The beveled-tip design, as reported, allows for multi-purpose functions in one, including blunt dissection, pick action, adhesion cutting, and even membrane peeling, which can reduce the need for ancillary instrumentation and reduce surgery time especially in complex RRD surgery (25).
It has been noted that 25-G vitrectomy for complex RRD has several disadvantages, including the impossibility of performing a complete peripheral vitrectomy, the limited number of required surgical instruments, and the longer operative time (3,4,7,24). However, the 10,000-cpm BTCP has a high cutting speed, a large port, and a beveled-tip design, which allow the vitreous to be thoroughly cleared with great efficiency, and it also achieved good anatomical and visual results in a series of eyes with complicated RRD.
Conclusions
The primary results of our study showed that 10,000-cpm BTCP is safe and effective for complex RRD surgery. Given the single-center prospective design of the study and the surgeon’s relatively limited experience with the 25-G probe, we speculate that the application of the 10,000-cpm BTCP will lead to more promising clinical outcomes in the future vitrectomy surgery. Multicenter randomized comparative studies need to be conducted in the future to improve our knowledge in this field.
Acknowledgments
The abstract of this paper was presented at the APVRS 2022 as an e-poster presentation with interim findings.
Footnote
Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://qims.amegroups.com/article/view/10.21037/qims-24-1460/rc
Funding: This article was supported, in part, by research grants from
Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://qims.amegroups.com/article/view/10.21037/qims-24-1460/coif). The authors have no conflicts of interest to declare.
Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013). Informed consent was obtained from all the individual participants included in the study. The study protocol was approved by the Institutional Review Board of the Eye and ENT Hospital of Fudan University (No. 2021021).
Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.
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