Andreas J. Reuland

Influence of 360-degree enhanced optic edge design of a hydrophilic acrylic intraocular lens on posterior capsule opacification

PURPOSE: To compare the rate of posterior capsule opacification (PCO) with the single‐piece hydrophilic acrylic foldable Rayner Centerflex 570H intraocular lens (IOL), which has a sharp optic edge design excluding the optic–haptic junction, and the Rayner C‐flex 570C IOL, which has an improved 360‐degree sharp edge. SETTING: Department of Ophthalmology, University of Heidelberg, Heidelberg, Germany. METHODS: As part of a multicenter U.S. Food and Drug Administration (FDA) study, 42 patients who had implantation of a C‐flex IOL in 1 eye after uneventful phacoemulsification were enrolled. Six and 12 months postoperatively, PCO was evaluated by retroillumination photographs using Evaluation of Posterior Capsule Opacification (EPCO) 2000 image‐analysis software. The data were then compared with those in a matched group of patients with a Centerflex IOL who participated in a previous FDA study. RESULTS: The mean age of the patients with the C‐flex IOL was 71.5 years ± 8.2 (SD) There was a statistically significant difference in EPCO scores between the C‐flex group and Centerflex group. Six months after surgery, the mean EPCO value (total IOL optic) was 0.07 ± 0.17 in the C‐flex group (n = 37) and 0.20 ± 0.20 in the Centerflex group (n = 36) (P<.01, Wilcoxon test). By 12 months, the mean had increased to 0.16 ± 0.20 in the C‐flex group (n = 37) and 0.35 ± 0.22 in the Centerflex group (n = 31) (P<.01, Wilcoxon test). CONCLUSIONS: The C‐flex IOLs showed good functional results and significantly lower PCO formation than the earlier model Centerflex IOL. The enhanced edge of the C‐flex IOL seemed to improve PCO prevention clinically.

Long‐term results of sealed capsule irrigation using distilled water to prevent posterior capsule opacification: a prospective clinical randomised trial

Background: We investigated long-term safety and efficacy of sealed capsule irrigation (SCI) during cataract surgery to prevent posterior capsule opacification (PCO). Methods: One eye of each of 17 patients (mean age: 70.1±9.7 years) who presented with bilateral cataracts was randomly chosen for SCI treatment. After phacoemulsification, the capsular bag was vacuum sealed with the PerfectCapsule device (Milvella) followed by SCI using distilled water for two minutes. No vacuum loss occurred during irrigation. Each patient’s fellow eye served as a control. One hydrophilic acrylic intraocular lens model was implanted in all eyes. Five patients had to be excluded due to deep anterior chamber, small pupil or unilateral surgery. Follow-up examinations took place one day and one, three, six, 12 and 24 months after surgery. We evaluated safety parameters, anterior capsule (AC) overlapping and PCO. Results: Postoperatively, mean best corrected visual acuity, pachymetry, endothelial cell count, intraocular pressure, AC overlapping and PCO showed no statistically significant difference between SCI and the control group (p>0.05, Wilcoxon test). Conclusion: SCI is a safe procedure and enables the specific pharmacological targeting of lens epithelial cells inside the capsular bag. Using distilled water, however, it is not possible to reduce PCO development significantly. Thus, alternative substances should be evaluated.

Prospective, non‐randomised, long term clinical evaluation of a foldable hydrophilic single piece intraocular lens: results of the Centerflex FDA study

Background: Owing to the improvement of modern intraocular lenses (IOLs) in terms of design and material, posterior capsule opacification (PCO) usually takes 2–3 years to develop. Thus, long term clinical evaluation of new implants is important. Methods: As part of a prospective, non-randomised FDA trial, the Rayner Centerflex, a foldable hydrophilic acrylic, single piece IOL was implanted in one eye of 83 patients (mean age 73.5 (SD 7.0) years). Over 3 years postoperatively, a standardised FDA protocol concerning IOL safety and efficacy was followed including evaluation of spherical equivalent (SE), best corrected distance visual acuity (BCDVA), endothelial cell count (ECC), flare meter values, PCO development, and anterior capsule shrinkage. Results: Postoperatively, mean SE was stable ranging between −0.3D and 0.17D. After 1–2 months, all patients achieved a BCDVA of 20/40 or better. At 3–6 months postoperatively, mean ECC decreased from 2612 (SD 346) cells/mm2 to 2380 (316) cells/mm2. Mean PCO score for the entire optic increased from 0.20 (0.20) months (3–6 months postoperatively) to 0.87 (0.57) resulting in a Nd:YAG rate of 29.41% after 3 years. No anterior capsule shrinkage was found. Conclusion: The Centerflex showed excellent functional results, low values for endothelial cell loss and inflammatory signs, and no anterior capsule shrinkage. PCO formation was higher compared to other IOLs, which could be explained by the incomplete sharp edge at the optic-haptic junctions representing an “Achilles’ heel” for cell ingrowth.

Comparison of anterior chamber depth measurements using Orbscan II and IOLMaster.

Purpose. To To evaluate and compare anterior chamber depth (ACD) measurements using Orbscan II (Bausch & Lomb, Rochester, NY) and IOLMaster (Carl Zeiss Meditec AG, Jena, Germany). Methods. In this prospective clinical study, the authors measured ACD of 145 phakic eyes of 30 healthy volunteers and 115 patients using Orbscan II and IOLMaster. Average patient age was 52.9±19.4 (range 16 to 87) years. ACD was evaluated from corneal epithelium to anterior lens surface. Additionally, axial length (AL) was measured using the Zeiss IOLMaster to calculate the regression coefficient between AL and ACD. Results. Mean ACD was 3.35±0.43 mm (range 2.01 mm to 4.37 mm) using Orbscan II and 3.36±0.41 mm (range 2.09 mm to 4.24 mm) using IOLMaster. Mean total axial length was 24.04 mm ± 2.1 mm (range 20.7 mm to 31.41 mm). The linear regression coefficient of ACD between both methods was R=0.95. ACD and AL correlated only slightly (R=0.57). The Spearman coefficients of rank correlation were 0.94 and 0.61, respectively. A p value less than 0.01 (paired Wilcoxon test) was considered statistically significant. However, a significant difference was not calculated comparing ACD measurements using both systems and the Bland-Altman-Plot showed 95% of the differences ranging between 0.25 and −0.27 mm. Conclusions. Regarding clinical application, both systems seem to be equally good and interchangeable in clinical practice in terms of ACD evaluation.

Cataract surgery in eyes with iridoschisis using the Perfect Pupil iris extension system

PURPOSE: To evaluate the use of the Perfect Pupil system (Milvella Pty. Ltd.) in 3 eyes in cataract surgery with iridoschisis. SETTING: Department of Ophthalmology, University of Heidelberg, Heidelberg, Germany. METHODS: Patient 1 was an 83‐year‐old man with a nuclear cataract, pseudoexfoliation syndrome, and iridoschisis. He was also having systemic anticoagulation therapy. Preoperative best corrected visual acuity (BCVA) was 0.05 in the right eye and 0.08 in the left eye. Patient 2 was a 73‐year‐old mentally retarded man with a brunescent cataract in the right eye. Preoperative BCVA was 0.1. RESULTS: In the first patient, cataract surgery was performed under topical anesthesia in both eyes through a clear corneal incision. Intraoperative pupil size was 3.0 mm. The Perfect Pupil device was inserted manually and fixated at the iris rim, leading to pupil dilation of 6.0 mm. Uneventful cataract surgery was performed without damage to the iris. Hydrophobic acrylic foldable intraocular lenses (IOLs) were implanted with forceps. Postoperative BCVA was 0.5 in the right eye and 0.4 in the left eye. The second patient was operated on under general anesthesia. Pupil dilation was successfully achieved. The brunescent cataract was removed and a hydrophobic acrylic IOL was implanted with an injector, resulting in postoperative uncorrected visual acuity of 0.3. CONCLUSION: In iridoschisis patients, there is risk of aspiration of iris fibers during cataract surgery. In these 2 patients, this was prevented using the Perfect Pupil system.

Transscleral fixation of a toric intraocular lens to correct aphakic keratoplasty with high astigmatism

A 71-year-old man with penetrating keratoplasty (PKP) and aphakia in the right eye and a preoperative refraction of +20.0 -11.0 x 38 and logMAR visual acuity of 20/60 presented to our hospital. The capsular support was absent because of previous complicated intracapsular cataract extraction. The implanted IOL was a custom-made Rayner 570T with +20.5 diopters (D) sphere and +11.0 D cylinder. The IOLs special haptics allowed it to be safely fixated in the sagittal plane. The postoperative refraction was +1.0 -2.0 x 5 with logMAR acuity of 20/60. Follow-up of 2 years revealed no IOL decentration. Transscleral fixation of a toric IOL requires exact outlining. Our case shows that this is possible and can result in improved visual rehabilitation.

Quantitative evaluation of acrylic and silicone intraocular lenses with a sharp optic edge design

BACKGROUND At the Department of Ophthalmology, Heidelberg, Germany, posterior capsule opacification (PCO) of a silicone and an acrylic intraocular lens (IOL) with a sharp optic edge design was evaluated. PATIENTS AND METHODS In a prospective study either the AMO ClariFlex silicone IOL or the Sensar AR40e hydrophobic acrylic IOL were implanted in 47 patients following uneventful phacoemulsification. Mean patient age was 76.2+/-7.8 (ClariFlex) and 73.4+/-12.9 years (AR40e), respectively. The mean follow-up time was 19.7+/-5.34 in the ClariFlex and 21.9+/-1.89 months in the AR40e group. PCO development was evaluated postoperatively using the EPCO 2000 analysis software (scale 0-4). Areas of interest were the total IOL optic, the central 3-mm zone as well as the capsulorhexis. RESULTS In both groups, all patients achieved a BCVA of 20/32 (AR40e) and 20/25 (ClariFlex), respectively. There was a very low incidence of PCO development with a mean EPCO score of 0.07+/-0.2 (ClariFlex and 0.15+/-0.2 (AR40e). Within the 3-mm zone and the capsulorhexis, there was a tendency for even lower EPCO scores in both groups. We calculated a statistically significant difference for the two lens materials for all investigated IOL areas (Wilcoxons test, p<0.05). CONCLUSION Both IOLs with a sharp edge design showed good functional results, a stable position in the capsular bag as well as a low incidence of PCO development. However, the silicone IOL showed statistically significantly lower PCO scores.

Quantitative Nachstarevaluierung von Acrylat- und Silikonintraokularlinsen mit scharfem Kantendesign

BACKGROUND At the Department of Ophthalmology, Heidelberg, Germany, posterior capsule opacification (PCO) of a silicone and an acrylic intraocular lens (IOL) with a sharp optic edge design was evaluated. PATIENTS AND METHODS In a prospective study either the AMO ClariFlex silicone IOL or the Sensar AR40e hydrophobic acrylic IOL were implanted in 47 patients following uneventful phacoemulsification. Mean patient age was 76.2+/-7.8 (ClariFlex) and 73.4+/-12.9 years (AR40e), respectively. The mean follow-up time was 19.7+/-5.34 in the ClariFlex and 21.9+/-1.89 months in the AR40e group. PCO development was evaluated postoperatively using the EPCO 2000 analysis software (scale 0-4). Areas of interest were the total IOL optic, the central 3-mm zone as well as the capsulorhexis. RESULTS In both groups, all patients achieved a BCVA of 20/32 (AR40e) and 20/25 (ClariFlex), respectively. There was a very low incidence of PCO development with a mean EPCO score of 0.07+/-0.2 (ClariFlex and 0.15+/-0.2 (AR40e). Within the 3-mm zone and the capsulorhexis, there was a tendency for even lower EPCO scores in both groups. We calculated a statistically significant difference for the two lens materials for all investigated IOL areas (Wilcoxons test, p<0.05). CONCLUSION Both IOLs with a sharp edge design showed good functional results, a stable position in the capsular bag as well as a low incidence of PCO development. However, the silicone IOL showed statistically significantly lower PCO scores.