To evaluate the safety of a foldable acrylic single-piece intraocular lens (IOL) in cases of complicated cataract surgery and sulcus implantation. The setting was University and private anterior segment surgery practices.
In this observational case series study, 13 eyes of 13 patients were included after complicated phacoemulsification with extensive posterior capsule rupture with or without vitreous loss. A foldable acrylic single-piece IOL (Rayner Superflex 620H; Rayner Intraocular Lenses Limited, Hove, East Sussex, UK) was implanted in the ciliary sulcus in each eye. Postoperative follow-up included best-corrected visual acuity, anterior segment biomicroscopy, IOL centration and position, intraocular pressure, and fundus biomicroscopy. Optical coherence tomography was performed in 2 subjects. Median follow-up time was 12 months (range 1-21 months).
Visual acuity 12 months after surgery was 6/18 and below in 5 eyes (39%), between 6/12 and 6/7.5 in 6 eyes (46%), and 6/6 in 2 eyes (15%). All patients experienced vision improvement. Postoperative complications included corneal edema (2 eyes), Descemet folds (1 eye), intraocular pressure elevations (3 eyes), and pronounced anterior segment inflammation (1 eye). Two eyes had minor pupil contour abnormalities. No significant IOL decentration was observed.
Sulcus implantation of a foldable acrylic single-piece IOL in eyes with complicated cataract surgery maintains the advantages of easy insertion and small incision. Postoperatively, all IOLs were centered, visual results were good, and complications were manageable and not IOL-related.
Eur J Ophthalmol 2012; 22(6): 950 - 955
Article Type: ORIGINAL RESEARCH ARTICLE
AuthorsGiulia Renieri, Daniel Herzog, Stefan Niemann, Matthias Becker, Sabine Kurz, Hagen Thieme
- • Accepted on 04/04/2012
- • Available online on 14/05/2012
- • Published in print on 15/10/2012
This article is available as full text PDF.
Cataract surgery using small incisions to implant a foldable intraocular lens (IOL) has been shown to provide safe intraoperative conditions combined with fast visual recovery and low incidence of surgery-induced astigmatism for the patient (1, 2). Single-piece IOLs are widely used (3, 4). In cases of posterior capsular bag ruptures—which can occur at any stage of surgery—a safe in-the-bag procedure is often problematic. Intraocular lenses can then be implanted in the ciliary sulcus. Intraocular lens implantation by means of transscleral sutures or retropupillary iris fixation is mandatory in case of complete loss of capsular bag support.
There have been some reports documenting the implantation of foldable acrylic IOLs in the ciliary sulcus (5, 6). This preserves the advantages of small incision surgery and produces minor additional stress for the eye with no significant increase of surgical time. However, it is commonly believed that 3-piece IOLs are more suitable for sulcus implantation, as the wider diameter of the haptics permits the IOL to be more easily centered in the sulcus and confers stability to the lens, preventing its dislocation.
The Rayner Superflex 620H (Rayner Intraocular Lenses Limited, Hove, East Sussex, UK) is a one-piece foldable acrylic IOL with wide haptics and larger optic diameter which has been proposed for sulcus fixation (7). In this study we investigated the safety of implanting a single-piece foldable acrylic IOL (Rayner Superflex 620H) into the ciliary sulcus in complicated cataract surgery with posterior capsular bag ruptures.
This observational case series included 13 eyes of 13 patients (6 male, 7 female) with posterior capsule ruptures during standard cataract surgery for senile cataracts in 12 patients and traumatic cataract in 1 patient. Patients were recruited during March 2005 and January 2008. Foldable acrylic single-piece IOLs (6.25 mm optic, 12.50 mm overall length; Rayner Superflex 620H;
Rayner intraocular lens (IOL) (Superflex 620H) showing haptics design and broad configuration in the plane view (6.25 mm optic, 12.50 mm overall length). The large haptics might contribute to IOL stability in the ciliary sulcus.
Patients’ mean age was 68.3 years (range 61 to 90 years). Surgery was performed by 3 experienced cataract surgeons (S.N., M.B., and H.T.), who implanted the Rayner Superflex 620H in every case of capsular bag tears with sufficient capsular bag support. Thus, the cases reported represent all their cases of capsular rupture in the study period that could be managed with a sulcus implantation. In case of severe capsular bag damage, IOLs for retropupillary iris fixation were used. According to their preference either topical or peribulbar anesthesia was used. Sclerocorneal or clear corneal 3-step incisions were created (width 2.8 to 3.0 mm). Phacoemulsification was performed using either the Stellaris (Bausch & Lomb, Rochester, New York, USA) or Accurus device (Alcon Laboratories Inc., Fort Worth, Texas, USA) and the divide-and-conquer or stop-and-chop techniques were performed. The cortex was cleaned using the machine’s automatic irrigation/aspiration system. After the posterior capsule tear developed, a stepwise approach was used to prevent the emergence or increase of vitreous loss, to ensure no progression of the capsule rupture and maintaining a closed, stable pressure system. If capsule rupture occurred before completion of nucleus removal, the torn area was tamponaded with sodium hyaluronate (Healon, AMO, Santa Ana, California, USA), nuclear remnants were elevated, and iris plane phacoemulsification was performed with a low flow rate, low ultrasound, high vacuum, and low bottle height. In case of vitreous loss, anterior vitrectomy was performed before phacoemulsification. When posterior capsule ruptures developed during cortex aspiration, the cortex was cleaned and anterior vitrectomy was performed if vitreous prolapse was observed. Then, in all cases a space was created in the sulcus by injecting viscoelastics in the anterior chamber and between the anterior capsule and the posterior iris. Capsular bag sufficiency and suitability were closely monitored. If needed, incision was widened to 3.2 mm for better injector control. The foldable IOL was implanted using the injector and the leading haptic positioned in the sulcus. The trailing haptic was then guided into the preformed space by means of a second instrument such as a manipulator. The IOL was unfolded at the sulcus plane.
Subsequent stages of intraocular lens sulcus implantation.
Median follow-up time was 12 months (range 1 to 21 months). Postoperative examinations were performed on the first day postoperatively, in the first week, and after 1, 3, and 12 months after surgery. Objective evaluation included refraction, best-corrected visual acuity (BCVA), IOP, IOL centration, and anterior segment and fundus biomicroscopy. Optical coherence tomography (OCT; RTVue-100, Optovue Europe GmbH, Heidelberg, Germany) was performed in selected cases to confirm lens centration and exclude iris contact and friction with the IOL. The study was performed according to good clinical practice guidelines and followed the tenets of the Declaration of Helsinki as revised in Edinburgh in 2000. All patients gave their informed consent and Institutional Review Board approval was obtained for this publication.
Posterior capsule tear occurred in different stages during surgery (
STAGE IN WHICH POSTERIOR CAPSULE RUPTURE OCCURRED (13 EYES OF 13 PATIENTS)
|No. (%) of eyes|
|Intraocular lens placement||1 (7.7)|
Preoperative BCVA was 6/30 and below in 4 eyes (31%) and ranged from 6/24 to 6/12 in 9 eyes (69%). The BCVA on the first day postoperatively was 6/30 and lower in 6 eyes (46%) and 6/24 and above in 7 eyes (54%). After the third month, BCVA of 6/18 and below was observed in 4 eyes (31%) and 6/15 and above in 9 eyes (69%). Final visual acuity after 12 months was 6/18 and below in 5 eyes (39%), between 6/12 and 6/7.5 in 6 eyes (46%), and 6/6 in 2 eyes (15%). Postoperative BCVA was limited in 3 patients due to age-related macular degeneration, in 1 patient due to amblyopia in the operated eye, and in 1 patient because of postoperative retinal detachment involving the macula.
Mean best-corrected visual acuity (± standard error of the mean; d1 = 1 day after surgery, m3 = 3 months after surgery, m12 = 1 year after surgery).
Mean postoperative refractive error (spherical equivalent) at the final examination was –2.20±1.04 D (mean ± standard error of the mean). Reduced vision in the early period was mostly due to corneal edema (2 eyes) and Descemet folds (1 eye). Transient complications included IOP elevations (3 eyes) and pronounced anterior segment inflammation (1 eye). Two eyes had minor pupil contour abnormalities. One patient with secondary cataract after a history of ocular trauma developed retinal detachment 4 months after cataract surgery. Retinal surgery (pars plana vitrectomy with silicone oil tamponade) was then performed without IOL-related complications. All patients experienced vision improvement after cataract surgery. No IOL decentration was observed in any patients during the postoperative follow-up.
Optical coherence tomography showing centered intraocular lens (IOL) and position of the scan. There is no iris-IOL contact.
Posterior capsule ruptures during cataract surgery occur in about 2%-4% of cases (8, 9), mostly during middle and final stages, e.g. phacoemulsification, irrigation, and aspiration maneuvers, IOL implantation or polishing (10, 11). Completion of surgery is possible in most cases (10, 12) and the IOL may be inserted in the capsular bag only if the rupture is small and the zonules seem stable. Otherwise implantation in the ciliary sulcus is necessary. This can be accomplished using the existing small incisions and preventing the surgeon from the need of enlarging the incisions, which can preserve many advantages of small-incision surgery. Keeping the anterior chamber stable by preservation of a closed system might minimize vitreous loss and reduces the probability of complications such as peripheral retinal tears, hypotony, choroidal detachment, and cystoid macular edema (13-14-15). The use of a foldable IOL, which can be easily inserted in the ciliary sulcus, therefore may be a good option to ensure a better prognosis. Three-piece IOLs are generally accepted to be the best choice in these cases, but long-term data seem controversial (16). The use of single-piece IOLs in cases of capsular tears and sulcus implantation is currently controversially discussed and data are limited (6, 17, 18).
In our case series we implanted a foldable acrylic single-piece IOL in the sulcus in 13 eyes of 13 patients with large posterior capsule tears during cataract surgery. None of these IOLs showed signs of decentering during the follow-up. Taskapili et al reported decentered single-piece IOLs in 4.49% and 1 dislocated IOL (1.12%) in the first year of follow-up, so that repositioning had to be performed in 2 eyes (6). Brazitikos et al reported decentered IOLs in 17.85% of their patients but no adverse effects on vision with 3-piece IOLs (5). This discrepancy to our results could be explained by the difference in IOL design, as the flexible haptics of the single-piece IOL we used offer an implantation diameter ranging from 9.5 to 12.5 mm due to the material’s flexibility. Other IOLs might be more rigid and thus less adaptable to different eye sizes.
Brazitikos et al implanted a 3-piece foldable acrylic IOL into the sulcus in 28 eyes of 28 patients developing posterior capsule tear during phacoemulsification (5). This group did not report any problems with decentered or luxated IOLs in their study. However, there are reports in which spontaneous disinsertion of IOL haptics into the anterior chamber has been described in similar patients (19). Taskapili et al performed sulcus implantation of single-piece acrylic IOLs in 89 eyes of 88 patients after posterior capsule tears during phacoemulsification (6). However, the authors included eyes with sufficient capsule support, which differs from our study, as we included extensive capsular bag ruptures. We did not observe any problems with dislocated IOLs nor haptics.
A disadvantage of implanting single-piece IOLs into the ciliary sulcus might be the narrow contact of the haptics to the back of the iris, which could cause pigment dispersion, increased IOP, or pain. LeBoyer et al reported 3 cases, in which acrylic single-piece IOLs were explanted due to such complications (18). In our study no patient showed any signs of iris chaffing. This might be due to the special design of the Rayner Superflex 620 H: the lens has a flat angle between optic and haptics’ base, and the large haptics may prevent movement in the IOL plane thus providing stability. Furthermore, pigment dispersion with elevated IOP has also been observed in eyes with 3-piece IOLs (19, 20).
Chang et al describe significant complications after sulcus placement of single-piece acrylic IOLs and conclude that IOLs designed solely for capsular bag implantation should not be placed in the ciliary sulcus (17). In their retrospective survey on complications after sulcus implantation of single-piece acrylic IOLs, Chang and coauthors identified 30 patients with complications. Twenty-nine of them had single-piece AcrySof IOL (Alcon, Inc.), and the most common model was the SA60AT (17). They believe that this IOL is not indicated for sulcus implantation for its design and for its hydrophobic acrylic material: the tacky and textured finish can cause chaffing of the posterior iris surface, which possibly leads to secondary glaucoma and chronic uveal inflammation. Given these data, we did not use AcrySof IOLs for sulcus implantation and for this study we chose the Rayner Superflex 620H also for its hydrophilic surface. The Tecnis® 1-piece IOL (Abbott Medical Optics Inc. [AMO]) has a wide haptic diameter (13 mm) but is made of hydrophobic acrylic material, as is the AcrySof IOL, so we do not feel comfortable in implanting this type of IOL in the ciliary sulcus.
In our series, early postoperative complications such as corneal edema, Descemet folds, pronounced anterior chamber inflammation, and IOP elevation occurred in 4 patients, were all temporary, and were comparable in incidence with studies by other groups with different IOLs (5, 6). These complications seem to be linked to the prolonged and complicated surgery itself, rather than to the type of IOL. No other complications were observed in the long term, except for retinal detachment in one patient with traumatic cataract.
In our study, final BCVA reached 6/12 and above in 62% of the patients; this visual result rose to 89% if preexisting factors predisposing to poor vision (e.g., age-related macular degeneration and amblyopia) were excluded. This is comparable to previous studies. Brazitikos et al reported final BCVA of 20/30 and above in 71.4% (5) and Taskapili et al reported BCVA of 5/10 and above in 82.02% in the first year (6).
The most serious postoperative complications are retinal tears and hence retinal detachment. We did not notice any retinal tears in our patients during postoperative follow-up, but 1 patient with a history of traumatic cataract following nonpenetrating ocular trauma developed severe retinal detachment involving the macula 4 months after phacoemulsification. The BCVA was 6/75 at baseline, and 6/15 1 week after cataract surgery. Visual acuity decreased to 6/120 with retinal detachment. After surgery including circling band, pars plana vitrectomy, and silicone oil tamponade, visual acuity rose to 6/60 postoperatively. After removal of silicone oil BCVA increased to 6/30. Other groups reported retinal tears in 1.6% to 3.57% after cataract surgery complicated by posterior capsule ruptures (5, 21). Taskapili et al observed 1 case of retinal detachment (1.1 %) in their study (6).
We conclude that implantation of an acrylic single-piece IOL such as the Rayner Superflex 620 H into the ciliary sulcus is a safe option if significant posterior capsule rupture occurred during cataract surgery and in-the-bag implantation is not possible. In this way, many advantages of small-incision surgery can be maintained, making surgery safer. However, adequate capsular bag support should be available to support sulcus-implanted IOLs. In this study we present good final levels of visual acuity while no problems with IOL decentering or haptic dislocation were observed. Ciliary sulcus implantation of acrylic single-piece IOLs with a certain design therefore might be a good option in suitable patients.
- Renieri, Giulia [PubMed] [Google Scholar] 1
- Herzog, Daniel [PubMed] [Google Scholar] 1
- Niemann, Stefan [PubMed] [Google Scholar] 2
- Becker, Matthias [PubMed] [Google Scholar] 3
- Kurz, Sabine [PubMed] [Google Scholar] 1
- Thieme, Hagen [PubMed] [Google Scholar] 1, * Corresponding Author (firstname.lastname@example.org)
Department of Ophthalmology, University Medical Center of the Johannes-Gutenberg-University, Mainz - Germany
Private practice, Bochum - Germany
Private practice, Höxter - Germany