Extracapsular surgery with intraocular lens (IOL) implantation in the capsular bag is the most common technique in treatment of cataract.1 However, none of the available IOL designs can guarantee an optimal positioning in the bag.2–4 Furthermore, capsular bag shrinkage can lead to IOL movement after surgery.5–7 Image-guided femtosecond lasers can perform a repeatable anterior capsulotomy with programmed size and perfect circularity.8,9 New IOL designs, based on the idea of the bag-in-the-lens technology by Tassignon, use this laser capsulotomy for IOL fixation.10,11 The refractive outcome might be improved because of the fixation of the IOL, especially in premium cases such as toric or multifocal IOLs. So far, the experiences with these new capsule-fixated IOLs are limited. Complex eyes might profit most by this new technology and ideally can be treated. In this case series, the implantation in small pupils is described.
Patients and Methods
In this case series, an anterior capsule–fixated IOL (FEMTIS; Oculentis, Berlin, Germany) (Figure 1) was implanted in patients with small pupils. The included surgeries were part of a multicenter clinical trial and were high-definition videotaped. We selected those cases with the pupil coming down intraoperatively and used this technique consistently. For capsule fixation, the IOL has two large flaps (longitudinal) and two small flaps (latitudinal) at the side of the optic (Figure 1). The two large flaps have openings for IOL positioning. The IOL has an aspheric optic design and is made of hydrophilic acrylic with a hydrophobic surface. The optic has a diameter of 5.7 mm and a 360° posterior sharp edge. The overall length is 10.5 mm. Included were eyes with a pupil size smaller than the capsulotomy (5 mm) prior to IOL implantation.
Capsule-fixated intraocular lens (IOL). (A) Top view showing two large and two small flaps to be fixated in the anterior capsulotomy. (B) Side view showing flaps in another plane than the regular haptics.
All surgeries were performed by the same experienced surgeon (HBD). The image-guided femtosecond laser treatment was performed with the LensAR system (LensAR, Orlando, FL). All patients were part of the trial “Stability of Lens Position of the FEMTIS® FB-313 after Femtosecond-Assisted Capsulotomy. An International Multicenter Study” and signed an informed content. The tenets of the Declaration of Helsinki were observed. The trial was approved by the local ethics committee (protocol number: 15-5413).
The patient was positioned on the surgical bed in the operating room and then docked to the laser system with the fluid-filled patient interface. The anterior segment was visualized with the integrated Scheimpflug camera and the treatment zones were positioned automatically. A 5-mm capsulotomy (incision depth: 1,000 µm, pulse energy: 4 µJ, vertical spot spacing: 18 µm, horizontal spot spacing: 3 µm) and lens fragmentation were performed. After laser treatment, the patient was moved under the operation microscope (Lumera T; Zeiss, Oberkochen, Germany). Two 1.2-mm side port incisions were created and the anterior chamber was filled with ophthalmic viscosurgical device (OVD). The so-called dimple-down maneuver was used to ensure a free anterior capsule disc. A 2.75-mm main incision was created and the fragmented lens was aspirated with the phacoemulsification tip. Bimanual irrigation and aspiration was used to remove the cortex.
The capsular bag was filled with OVD (Healon; Abbot Medical Optics, Santa Ana, CA). The IOL was positioned in the cartridge with an anterior orientation of the capsule fixation flaps. Then the IOL was gently implanted through the small pupil into the capsular bag. Bimanual irrigation and aspiration was used to remove the OVD, also behind the IOL. Next, OVD was again injected homogenously into the anterior chamber on top of the IOL optic. An iris manipulator (Frankfurt model; Geuder, Heidelberg, Germany) was used to elevate the large and small flaps to the front of the iris starting with the large flap opposite to the main incision (Figure 2), whereas the IOL haptics remained in the capsular bag. Next, the iris was carefully flipped over the flaps with the OVD cannula or the manipulator, so the IOL flaps remained on top of the anterior capsule. Finally, the OVD was carefully removed with the irrigation and aspiration handpiece through the main incision and the corneal incisions were hydrated with balanced salt solution, if necessary (Video 1, available in the online version of this article).
Intraoperative view of the capsule-fixated intraocular lens (IOL) after positioning the flaps on the iris in a small pupil case. Next, the iris is flipped over the flaps to position the IOL correctly.
The IOL was implanted in 4 eyes of 2 patients with a small pupil. The patients' ages were 67 and 75 years. In all eyes, the pupil diameter before laser treatment was 7 mm or larger. No suction loss or other complications occurred during laser treatment. Prior to IOL implantation, the pupil size was smaller than 5 mm in all eyes. With the described technique, the implantation of the capsule-fixated IOL was possible in all cases. No case experienced an anterior capsule tear, damage to the iris, or other intraocular complications. Furthermore, no complications (eg, increased inflammation, fibrin reaction, tilt, optic or haptic degradation, pigment dispersion, iris capture, or macular edema) were seen within the first days after surgery or 2 months postoperatively. The follow-up examination after 2 months showed that both the large and small flaps were in the correct position. The intraocular pressure 1 day after surgery was 12 ± 3 mm Hg (range: 11 to 13 mm Hg). The mean uncorrected distance visual acuity was 0.05 logMAR (range: 0.1 to 0.0 logMAR) at 2 months postoperatively. The mean spherical equivalent was 0.09 diopters (range: −0.125 to 0.50 diopters).
Cataract surgery is changing into a refractive procedure with high patient expectations.12,13 An optimal IOL position is essential for optimal postoperative results, especially in premium IOL cases.7 Capsule-fixated IOLs are a new and promising option to achieve a stable IOL position intraoperatively.10 However, intraoperative floppy iris syndrome or cases with the pupil coming down intraoperatively cannot be excluded before surgery. Other circumstances such as femtosecond laser treatment or iris trauma during surgery can also lead to an intraoperative pupil constriction.14,15 With the described technique, the new capsule-fixated IOLs can be positioned easily and safely in cases with intraoperative small pupils. No eyes had complications or intraocular damage. However, larger trials are necessary to confirm these findings. In the near future, toric and multifocal versions of the capsule-fixated IOL will be available. Nevertheless, comparative trials are required to investigate the advantages and disadvantages in comparison to other IOL designs, including the incidence of posterior capsule opacification. More clinical trials with longterm follow-up data on refractive outcome and possible complications are warranted. Moreover, new surgical solutions have to be developed to solve unexpected intraoperative incidents such as anterior or posterior capsular tear and for challenging cases.
Capsule-fixated IOLs can also be implanted in eyes with a small pupil and have a great potential to improve the postoperative refractive outcome.
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