Bilateral Artificial Iris implantation in patients with bilateral iris defects





Abstract


Purpose


Binocular traumatic or atraumatic iris defects can lead to an increased sensitivity to glare and cosmetic disfigurement. Surgical iris reconstruction is one approach to alleviate these problems. We report the clinical outcomes after medically indicated bilateral implantation of an Artificial Iris prosthesis in three patients with binocular iris defects with different etiologies.


Observations


All three patients underwent binocular CUSTOMFLEX ArtificialIris (AI) (HumanOptics AG, Erlangen, Germany) implantation with simultaneous cataract surgery. Corrected distance visual acuity (CDVA), manifest refraction, Contrast sensitivity, endothelial cell density and subjective visual impairment as well as subjective cosmetic disfigurement were measured pre- and postoperatively. CDVA remained stable or improved in all three patients. We observed an increase in contrast sensitivity and reduction of glare sensitivity in two patients. All patients reported satisfaction with the cosmetical result after the implantation.


Conclusions and importance


The bilateral Artificial Iris implantation is an effective therapeutic option to reduce glare sensitivity and to achieve an aesthetically pleasing result also in selected patients with binocular traumatic or atraumatic iris defects.



Introduction


Patients with monocular iris defects often report photophobia and glare sensitivity and suffer from severe visual impairment and cosmetic disfigurement. Such complaints can be even more pronounced in patients with rare bilateral iris defects.


Conservative therapeutic options include wearing sunglasses for temporary relief or iris print contact lenses. These tinted contact lenses can effectively reduce the visual symptoms and provide an aesthetically pleasing solution, but some patients are intolerant to contact lens wear or are unable to handle them. Furthermore, contact lenses require regular cleaning or need to be exchanged and this generates ongoing costs. Corneal tattooing can also be performed in patients with iris defects, but there are several risks associated with this procedure, such as micro-perforation or recurring corneal erosions. Inhomogeneous or fading pigmentation have also been reported. A study examining corneal tattooing in 147 disfigured eyes found a complication rate of 12%, with most complications leading to repeat surgery. The goal of corneal tattooing is to achieve a good aesthetic outcome, but the problem of glare usually remains, because such tattoos are not completely lightproof.


Surgical iris reconstruction with an Artificial Iris implant is another therapeutic option that may be advantageous in the long term. The silicone prosthesis is handcrafted to match the color of the patient’s remaining iris tissue and it can be implanted using various techniques depending on the comorbidities present. The implantation of an Artificial Iris prosthesis has shown good functional and aesthetic results in patients with monocular iris defects. In this case series, we report about our experience in patients who underwent binocular implantation of the CUSTOMFLEX ArtificialIris (AI, Fig. 1 ) (HumanOptics AG, Erlangen, Germany).




Fig. 1


Artificial Iris Customflex (HumanOptics, Erlangen, Germany) after trephination. A) Anterior View. B) Posterior view of a partially folded device.



Materials and methods



Surgical technique


The surgical techniques to implant an AI are varied and have been described in detail elsewhere. , , The three patients in this present case series had surgery in both eyes with a delay of 2–8 weeks under general anesthesia, performed by one surgeon (CM): phacoemulsification with subsequent IOL implantation into the capsular bag as well as an AI implantation. The same model of intraocular lens (MC6125AS-Y, HumanOptics, Erlangen, Germany) was implanted in all patients. The AI wastrimmed to a size slightly smaller than the white-to-white value or the expected capsular bag diameter. In both eyes of one patient (case 1), the AI was ultimately implanted into the ciliary sulcus after intraoperative problems with the centration of the device in the capsular bag. The AI implants were prepared with prophylactic iridectomies to reduce the risk of IOP elevation, as the AI was placed in the sulcus in this case. In two patients (case 2 and 3) the AI was implanted into the capsular bag. In these cases, a capsular tension ring was used to prevent capsular shrinking, as this might cause a position change or tilting of the AI. In all cases, an AI without embedded fiber was used. All surgeries were performed without significant complications.



Follow-up


The follow-up time ranged from 11 to 14 months post-surgery. Postoperative assessment was performed at 3 months post-surgery. Corrected distance visual acuity (CDVA) and manifest refraction, as well as contrast sensitivity and endothelial cell density, were determined pre- and postoperatively. Contrast sensitivity was measured using a Pelli Robson Chart. Furthermore, the patients were asked to rate their sensitivity to glare and the discontent with their eyes’ appearance on a numerical scale from 1 to 10, with 1 standing for low and 10 standing for high severity. This assessment was done preoperatively and postoperatively. At the postoperative follow-up, patients were asked to additionally rate their overall satisfaction with the result on a numerical scale from 1 to 10 with 1 standing for very low satisfaction and 10 standing for maximum satisfaction. Patients were also asked if they would undergo the same procedure again if they had the choice.



Findings



Case 1 ( Fig. 2 )


A woman in her fifties presented with intense glare and cosmetically disturbing anisocoria and decentration of the pupil ( Fig. 2 A–C). She reported a history of bilateral iritis. The patient had not been treated for her symptoms before. The patient rated both the visual impairment resulting from glare and the discontent with her eye’s appearance with the maximum value of 10 on the numerical scale. The slit lamp examination revealed an anisocoria of 1.2 mm (L > R) and iris transillumination defects on both eyes, as well as a beginning bilateral subcapsular cataract. The fundus examination was without pathological findings in both eyes. CDVA was 0.00 logMAR with a manifest refraction (MR) of −2.5 diopters sphere (DS)/-1.0 diopters cylinder (DC) x 93° on the right eye and 0.00 logMAR with a MR of -3.25 DS on the left eye. Preoperative contrast sensitivity was 1.35 log units on both eyes.




Fig. 2


Case number 1. A) Preoperative binocular photograph. B) Preoperative close-up photograph of the right eye. C) Preoperative close-up photograph of the left eye. D) Postoperative binocular photograph with ArtificialIris in both eyes. E) Postoperative close-up photograph with ArtificialIris in the right eye. F) Postoperative close-up photograph with ArtificialIris in the left eye.


A MC6125AS-Y IOL (HumanOptics) with a power of +22.0D was implanted in both eyes. The target refraction was −2.82 D for the right eye and −3.44 D for the left eye. The AI diameter was 12.0 mm for both eyes. On the left eye, the AI was first implanted into the capsular bag together with the IOL. The patient at first was not satisfied with the cosmetic result. A slight decentration of the new pupil was visible because the diameter chosen for the trephined implant had been too small. The AI was explanted in a second surgery a few days later, and the stand-by AI was implanted into the ciliary sulcus. One week later, the IOL was implanted in the capsular bag of the fellow eye, while the AI was implanted into the ciliary sulcus.


Fourteen months after surgery, the CDVA was 0.00 logMAR on both eyes, with an MR of −3.25 DS on the right eye and an MR of −3.75 DS on the left eye. Contrast sensitivity values were 1.5 log units for the right eye and 1.35 log units for the left eye. The endothelial cell density (CD) had slightly decreased from 3145 to 3049 on the right eye and from 3135 to 2924 on the left eye. The patient reported a considerable reduction in glare sensitivity and was very satisfied with the cosmetic result ( Fig. 2 D–F). Subjective visual impairment due to glare and subjective discontent with her eye’s appearance were now both 1 on the 10-point numerical scale. The online supplementary video shows the surgical procedure of this patient’s right eye.



Case 2 ( Fig. 3 )


A male patient in his seventies presented with unclear persistent mydriasis with severe photophobia and decreased visual acuity ( Fig. 3 A–C). The reason for the bilateral permanent mydriasis remained unclear as the patient could not remember any trauma. The patient had not been treated for his complaints so far. He rated the visual impairment resulting from glare with 10 and surprisingly the discontent with his eye’s appearance only with 2 on the 10-point numeric scale. In the slit lamp examination, both eyes showed a permanent mydriasis and cataract. Both eyes showed no retinal pathologies. CDVA was 1.00 logMAR on the right eye, with an MR of +5.0 DS/-2.75 DC x 3°, and 0.70 logMAR on the left eye, with an MR of +3.75DS/-2.0 DC x 175°. Preoperative contrast sensitivity was 1.35 log units on both eyes.




Fig. 3


Case number 2. A) Preoperative binocular photograph. B) Preoperative close-up photograph of the right eye. C) Preoperative close-up photograph of the left eye. D) Postoperative binocular photograph with ArtificialIris in both eyes. E) Postoperative close-up photograph with ArtificialIris in the right eye. F) Postoperative close-up photograph with ArtificialIris in the left eye.

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Jul 10, 2021 | Posted by in OPHTHALMOLOGY | Comments Off on Bilateral Artificial Iris implantation in patients with bilateral iris defects

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