Comparison of Long-Term Rotational Stability of Three Commonly Implanted Intraocular Lenses.

PURPOSE: To compare rotational stability and its influencing factors in 3 different widely used hydrophobic acrylic intraocular lenses (IOLs) from the end of surgery (EoS) to 4-7 months (6 months) in over 380 eyes. DESIGN: Prospective interventional comparative clinical study. METHODS: Setting: Department of Ophthalmology, Medical University of Vienna. PATIENT POPULATION: A total of 381 eyes of 199 patients with age-related cataract received an IOL Acrysof SN60WF, Tecnis ZCB00, or Envista MX60 in a consecutive order. INTERVENTION: Implantation of an Acrysof, Tecnis, or Envista IOL randomized to the 0 ± 10, 45 ± 10, 90 ± 10, or 135 ± 10° axis in 1 or both eyes. Baseline measurement was performed with patients supine still on the operating table. Postoperative follow-ups were conducted after 1 hour, 1 week, 1 month, and 6 months. MAIN OUTCOME MEASURES: Difference of absolute rotation from the EoS to 6 months. RESULTS: Absolute rotations from the EoS to 6 months were 1.65 ± 2.1, 2.65 ± 4.1, and 3.18 ± 5.8° for the Acrysof, Tecnis, and Envista group, respectively. Rotational stability was statistically significantly superior in the Acrysof compared with the Envista group (P = .014), but not compared with the Tecnis group (P = .10). No significant difference was found between the Tecnis and Envista groups (P = .761). Maximum values of 15.8, 38.6, and 44.9° were observed for the Acrysof, Tecnis, and Envista group, respectively. CONCLUSION: The Acrysof IOL showed the least amount of absolute rotation compared with the Tecnis and Envista IOLs. Outliers possibly requiring secondary intervention were observed in all groups. The amount of rotation was greatest during the first postoperative hour.

Posterior Capsule Opacification With Two Hydrophobic Acrylic Intraocular Lenses: 3-Year Results of a Randomized Trial.

PURPOSE: To compare the incidence and intensity of posterior capsule opacification (PCO) and neodymium-yttrium-aluminum-garnet (Nd:YAG) capsulotomy rates between 2 similar open-loop single-piece hydrophobic acrylic intraocular lenses (IOLs) that differ in the proprietary material characteristics and design features, over a period of 3 years. DESIGN: Randomized, prospective, patient- and examiner-masked clinical trial with intraindividual comparison. METHODS: Setting: Department of Ophthalmology, Medical University of Vienna, Vienna, Austria. PATIENT POPULATION: Eighty patients (160 eyes) had bilateral cataract surgery and received a Vivinex XY1 IOL in 1 eye and an AcrySof SN60WF IOL in the other eye. OBSERVATION PROCEDURES: Follow-up examinations were performed 3 years after surgery. Digital retroillumination images were taken of each eye. The amount of PCO (score: 0-10) was assessed subjectively at the slit lamp and objectively using automated image analysis software (AQUA). MAIN OUTCOME MEASURE: PCO score (scale, 0-10). RESULTS: The mean objective PCO score of the Vivinex XY1 IOLs was 0.9 ± 0.8 compared to the PCO score of 1.4 ± 1.1 for the AcrySof SN60WF IOLs (P < .001). Three years postoperatively, 11.4% of patients had an Nd:YAG capsulotomy in the Vivinex XY1 eye and 18.6% had a capsulotomy in the AcrySof SN60WF eye (P = .23). CONCLUSION: The new hydrophobic acrylic Vivinex XY1 IOL showed significantly lower PCO rates and lower YAG rates compared to the AcrySof SN60WF IOL. The interaction of various factors such as hydrophobic material, smooth optic surface, and sharp posterior optic edge plays a key role in PCO development.

Posterior capsule opacification and Nd:YAG laser rates with two hydrophobic acrylic single-piece IOLs.

OBJECTIVES: To evaluate the development of posterior capsule opacification (PCO) and Nd:YAG capsulotomy rates following implantation of two hydrophobic acrylic IOLs. METHODS: In a randomized, controlled trial, 80 patients with bilateral senile cataract were implanted with the hydrophobic acrylic single-piece intraocular Lenses (IOLs) EyeCee One in one eye and iMics1 in the other. Outcomes of 39 patients (78 eyes) were evaluated after 3 years. Automated Quantification of After-Cataract (AQUA; for PCO occurrence), visual acuity, anterior fibrosis, capsule-optic edge interaction and distance between anterior and posterior capsule IOL surface were analysed. RESULTS: After a mean follow-up of 38 ± 1.95 months, Nd:YAG capsulotomy occurred at a rate of 15.4% and 46.2% in the EyeCee One and iMics1 groups, respectively (p < 0.01). Respective mean PCO scores measured by AQUA were 1.57 ± 1.63 and 2.45 ± 1.44 (p = 0.019). A distinct gap between the anterior capsule and the IOL optic was present in 89% of eyes implanted with EyeCee One and 13% of iMics1 eyes. A gap between the posterior capsule and the posterior surface of the lens was observed in 76% of EyeCee One eyes and 35% of iMics1 eyes. CONCLUSIONS: Study findings suggest that PCO and Nd:YAG capsulotomy rates are significantly lower in eyes implanted with the EyeCee One IOL compared to the iMics1 IOL. Optic sharpness and lens material seem to be the decisive factors, while the stepped edge beneath the haptic junction appeared to be ineffective.

Impact of primary posterior capsulorhexis on regeneratory after-cataract and YAG laser rates with an acrylic micro-incision intraocular lens with plate haptics: 1-year and 3-year results.

PURPOSE: To evaluate the posterior capsule opacification (PCO) and YAG laser capsulotomy (YAG-LCT) rates with a plate-haptic acrylic micro-incision intraocular lens (IOL) and the impact of primary posterior capsulorhexis. METHODS: A total of 97 patients scheduled for immediate sequential bilateral cataract surgery underwent a randomized, prospective intraindividual comparison with the ZEISS Asphina 409MV plate-haptic acrylic IOL with the eyes receiving an additional primary posterior capsulorhexis (PPCR) or not. YAG-LCT and PCO rates were evaluated at 1 and 3 years. Three-year PCO rates were calculated with a 3-scenario method for eyes that underwent YAG-LCT between 1 and 3 years. RESULTS: A total of 56 patients were seen at 1 year, and 57 at 3 years. For the eyes without and with PPCR, YAG-LCT rates were 14.3% and 0% at 1 year, and 59.7% and 3.5% at 3 years, respectively. Opacification rates at 1 year were 0.55 ± 0.99 and 0.05 ± 0.21 for the central 2-mm optic zone. A total of 42 patients completed both the 1- and 3-year follow-up. Three-year opacification rates for the group without PPCR were 1.99 ± 2.20, 2.26 ± 2.66 and 3.66 ± 3.61 for the central 2-mm zone and 2.57 ± 2.07, 3.13 ± 3.03 and 4.09 ± 3.34 for the 4.5-mm zone for the best, extrapolated and worst-case scenarios, respectively. CONCLUSION: The ZEISS Asphina 409MV plate-haptic acrylic IOL exhibited unusually high YAG-LCT and PCO rates with standard in-the-bag implantation. PPCR was safe and effective in preventing central opacification and the need for YAG laser treatment.

Efficacy and safety of capsular bending ring implantation to prevent posterior capsule opacification: three-year results of a randomized clinical trial.

PURPOSE: To determine whether a capsular bending ring (CBR) with a rectangular cross-section and sharp edges moves the barrier to the very equator and avoids contact between the capsulorhexis and optic to prevent posterior capsule opacification (PCO) and anterior capsule fibrosis. SETTING: Department of Ophthalmology, Medical University of Vienna, Vienna, Austria. METHODS: A 0.7 mm high, open poly(methyl methacrylate) CBR was implanted in 60 eyes (patients) in a prospective randomized intraindividual trial. The impact of additional CBR implantation on PCO and anterior capsule fibrosis was compared to that of intraocular lens (IOL) implantation alone using objective scoring. RESULTS: No CBR-related surgical complications occurred. The objective PCO score and area were statistically significantly reduced in the CBR group. In patients with complete follow-up, the mean PCO score (scale 1 to 10) at 1, 2, and 3 years was 0.8, 1.7, and 2.1, respectively, in the CBR group and 2.6, 3.9, and 4.6, respectively, in the no-CBR group. The number of quadrants affected by PCO was 0.9, 1.5, and 1.8 versus 3.2, 3.8, and 3.8. Barrier failures with the CBR were caused by the inherent slight edge blunting and occasional eyelet gaping. Laser capsulotomies were performed in the no-CBR group only. Capsule stress folds and fibrotic anterior capsule opacification were also greatly reduced. The best corrected visual acuity was better in the CBR group. CONCLUSIONS: Capsular bending ring implantation was an effective and safe adjunct to in-the-bag IOL fixation. With improvements in technology and design securing exquisitely sharp edges and circumferential capsular bending independent of the capsular bag diameter, this concept has the potential to prevent PCO and anterior capsule fibrosis.

Natural course of intraocular pressure after cataract surgery with sodium hyaluronate 1% versus hydroxypropylmethylcellulose 2%.

PURPOSE: To investigate the natural course of intraocular pressure (IOP) after small-incision cataract surgery with sodium hyaluronate 1% versus hydroxypropylmethylcellulose 2%. DESIGN: Randomized clinical trial. PARTICIPANTS: Eighty eyes of 40 consecutive patients with bilateral age-related cataract. METHODS: The patients were assigned randomly to receive sodium hyaluronate 1% or hydroxypropylmethylcellulose 2% during cataract surgery in the first eye. The second eye received the other ophthalmic viscosurgical device. The IOP was measured preoperatively and 30 minutes; 1, 2, 3, 4, 6, 8, and 20 to 24 hours; and 1 week postoperatively. MAIN OUTCOME MEASURE: Postoperative IOP increase. RESULTS: The highest mean IOP increase occurred at 8 hours postoperatively (5.3+/-6.4 mmHg) in the sodium hyaluronate 1% group and at 2 hours postoperatively (7.8+/-6.1 mmHg) in the hydroxypropylmethylcellulose 2% group. Overall, the IOP increase was higher with hydroxypropylmethylcellulose 2% (P = 0.005). Intraocular pressure spikes to > or =30 mmHg occurred in 5 eyes (13%) in the sodium hyaluronate 1% group and 13 eyes (33%) in the hydroxypropylmethylcellulose 2% group. CONCLUSIONS: Sodium hyaluronate 1% and hydroxypropylmethylcellulose 2% caused significant IOP increases during the first 8 hours after cataract surgery. A single measurement at 6 hours postoperatively could detect all IOP spikes in the sodium hyaluronate 1% group. In the hydroxypropylmethylcellulose 2% group, a single measurement at 2 hours postoperatively could detect two thirds of IOP spikes.

Long-term effect of 1-piece and 3-piece hydrophobic acrylic intraocular lens on posterior capsule opacification: a randomized trial.

PURPOSE: To compare the intensity of posterior capsule opacification (PCO) between the 1-piece and 3-piece haptic designs of the foldable hydrophobic acrylic AcrySof intraocular lens (IOL) over a 5-year period. DESIGN: Randomized, prospective, patient- and examiner-masked clinical trial with intraindividual comparison. PARTICIPANTS: Fifty-two patients with bilateral age-related cataract (104 eyes). METHODS: Each study patient had cataract surgery in both eyes and received a 1-piece AcrySof IOL in 1 eye and a 3-piece AcrySof IOL in the other eye. Follow-up examinations were performed at 1 week, 1 month, 6 months, and 1, 2, and 5 years. Digital retroillumination images were obtained of each eye. The amount of posterior capsule opacification (score range, 0-10) was assessed subjectively at the slit lamp and objectively using automated image analysis software 1, 2, and 5 years after surgery. MAIN OUTCOME MEASURE: Posterior capsule opacification score (scale, 0-10). RESULTS: There was no significant difference between the 1-piece and 3-piece AcrySof IOL in best-corrected visual acuity, overlap of rhexis and IOL, capsular folds, anterior capsule opacification, and posterior capsule opacification (1-piece AcrySof PCO score, 1.7+/-1.7; 3-piece AcrySof PCO score, 1.3+/-1.4; P = 0.30). CONCLUSIONS: Modification of the IOL haptic design of the sharp optic edged AcrySof IOL from a 3-piece to a 1-piece haptic design caused no significant change in PCO intensity and neodymium:yttrium-aluminium-garnet laser treatment rate 5 years after surgery.

Long-term effect of optic edge design in a silicone intraocular lens on posterior capsule opacification.

PURPOSE: To compare the posterior capsule opacification (PCO) inhibiting effect of the round anterior and sharp posterior optic edge profile of the Clariflex silicone intraocular lens (IOL) [AMO Inc, Santa Ana, California, USA] with that of the double-round edge profile of the SI40 (Phacoflex; AMO Inc, Santa Ana, California, USA) silicone IOL over a period of three years. DESIGN: Prospective, randomized, double-masked, bilateral clinical trial. METHODS: The study took place at the Department of Ophthalmology, Medical University of Vienna, Austria. Fifty-two patients with age-related cataracts (104 eyes) were included in the study. Each patient received an SI40 IOL (round edges) in one eye and a Clariflex IOL with OptiEdge (sharp posterior optic edge) in the other eye. Follow-up examinations were at one week, one month, six months, and one, two, and three years. Digital retroillumination images were taken of each eye. The amount of PCO was subjectively assessed with the slit-lamp and objectively assessed by automated image analysis software (the computer program Automated Quantification of After-Cataract [AQUA]; Vienna, Austria) one, two, and three years after surgery. RESULTS: The Clariflex lens showed markedly less PCO at one, two, and three years after surgery. The mean AQUA PCO score was 1.39 for the SI40 and 0.56 for the Clariflex lens after one year, estimated at 1.64 and 0.57 after two years, and at 2.04 and 0.64, respectively, after three years (scale zero to 10; P < .001). The Nd:YAG laser capsulotomy rate was far higher in the SI40 group (Five cases vs one case at three years). CONCLUSIONS: The sharp posterior optic edge profile of the Clariflex silicone IOL led to marked and consistently less PCO than the round-edged SI40 IOL one, two, and three years after surgery.

Effect of primary posterior continuous curvilinear capsulorhexis on clinical performance of ACR6D SE single-piece hydrophilic acrylic intraocular lenses.

PURPOSE: To evaluate the effects of a primary posterior continuous curvilinear capsulorhexis (PCCC) on the clinical performance of a single-piece hydrophilic acrylic intraocular lens (IOL) with haptic angulation. SETTING: Department of Ophthalmology, Medical University of Vienna, Vienna, Austria. METHODS: A prospective study of 52 patients with bilateral age-related cataract was conducted. Patients had standard cataract surgery with implantation of the same IOL in both eyes. Randomly, a PCCC was created in 1 eye and the posterior capsule was left intact in the fellow eye. Assessed parameters were visual axis opacification (VAO) in eyes with a PCCC or regeneratory posterior capsule opacification (PCO) in eyes without PCCC (scale 0 to 10) in the central (3.0 mm eccentricity), intermediate (3.0 to 4.5 mm eccentricity), and peripheral (>4.5 mm eccentricity [capsulorhexis edge]) areas; neodymium:YAG (Nd:YAG) laser capsulotomy or laser polishing of ongrowing lens epithelium; anterior capsule opacification (ACO); best corrected visual acuity (BCVA); and contrast sensitivity. RESULTS: Thirty patients completed the 2(1/2)-year follow-up. Visual axis opacification was significantly lower in the central region in the PCCC group (mean 0.5 +/- 0.7 [SD]) than PCO in the central region of the non-PCCC group (mean 1.1 +/- 1.1) (P = .02). Forty percent in the non-PCCC group had an Nd:YAG laser capsulotomy during the follow-up period; none in the PCCC group had laser polishing. There were no significant differences in ACO, SE, BCVA, or contrast sensitivity. There was no additional gain in BCVA or contrast sensitivity in eyes with a PCCC compared with eyes without a PCCC when VAO and PCO were low. CONCLUSION: A PCCC significantly reduced PCO formation within the central 3.0 mm eccentricity as well as the need for Nd:YAG laser capsulotomy in eyes with a single-piece hydrophilic acrylic IOL with angulated haptics.

Clinical effects of primary posterior continuous curvilinear capsulorhexis in eyes with single-piece hydrophilic acrylic intraocular lenses with and without haptic angulation.

PURPOSE: To evaluate the clinical effects of a primary posterior continuous curvilinear capsulorhexis (PCCC) on the intraocular performance of hydrophilic acrylic single-piece intraocular lenses (IOLs) with and without haptic angulation. SETTING: Department of Ophthalmology, Medical University of Vienna, Vienna, Austria. METHODS: A prospective study comprised 52 patients with bilateral age-related cataract who had standard cataract surgery including a PCCC. One eye of each patient was randomized to receive a hydrophilic acrylic IOL with haptic angulation (ACR6D SE, Laboratoires Cornéal) and the contralateral eye, a hydrophilic acrylic IOL without haptic angulation (C-flex 570C, Rayner). The following parameters were assessed: regeneratory posterior opacification (RPO) in the central, intermediate, and peripheral areas (scale 0 to 10); anterior capsule opacification (ACO); best corrected visual acuity (BCVA); and contrast sensitivity (CSF). RESULTS: Thirty-one patients completed the 1(1/2)-year follow-up. In both IOL groups, RPO within the PCCC was slight in the central area, with a mean score of 0.33 +/- 0.84 (SD) in the angulated IOL group and 0.16 +/- 0.57 in the nonangulated IOL group (P = .29). The mean RPO score in the peripheral area was 2.07 +/- 1.37 and 2.35 +/- 1.45, respectively (P = .12). The difference between the central and peripheral areas was 1.74 in the angulated IOL group (P<.00001) and 2.19 in the nonangulated IOL group (P<.00001). Haptic deformation occurred in 9 eyes (29%) with an angulated IOL and no eye with a nonangulated IOL. There was significantly more ACO in the nonangulated IOL group (P = .012). There were no significant differences in BCVA or CSF between the 2 groups. CONCLUSIONS: Creating a PCCC led to significantly lower RPO intensity within the PCCC area than in the peripheral area in eyes with hydrophilic acrylic IOLs with and without haptic angulation. Haptic angulation had no apparent significant influence on the intensity of RPO or on BCVA and CSF. Haptic deformation may occur in hydrophilic IOLs with angulated haptics.

Comparison of posterior capsule opacification development with 2 single-piece intraocular lens types.

PURPOSE: To evaluate the differences in the incidence of posterior capsule opacification (PCO) and visual and optical performance between 2 hydrophobic acrylic single-piece sharp-edged intraocular lenses (IOLs) over 3 years. SETTING: Department of Ophthalmology, Medical University of Vienna, Vienna, Austria. DESIGN: Prospective randomized case series. METHODS: Patients with bilateral cataract were prospectively randomized to receive an Eyecee One IOL (IOL A) or an Acrysof SN60WF IOL (IOL B) and were followed for 36 months. The corrected distance visual acuity (CDVA) and IOL decentration and tilt were measured. The PCO was quantified by analysis of standardized retroillumination images. RESULTS: The study comprised 160 eyes of 80 patients. The PCO incidence was low for both IOLs at all follow-up visits. Three years postoperatively, the median objective PCO score was 1.4 (range 0 to 5.6) for IOL A and 1.5 (range 0 to 5.0) for IOL B (P = .67). The neodymium:YAG (Nd:YAG) capsulotomy rate 3 years after surgery was 16.4% and 6.0% (P = .06), respectively. Visual acuity and contrast sensitivity outcomes were also comparable at all follow-up visits. CONCLUSIONS: Both IOLs showed good capsular bag performance and low PCO rates 3 years after surgery. Both IOLs also showed comparable results for visual acuity, contrast sensitivity, decentration and tilt, PCO score, slitlamp examination, and Nd:YAG capsulotomy rates.

Effect of optic material and haptic design on anterior capsule opacification and capsulorrhexis contraction.

PURPOSE: To examine the influence of optic material (silicone and hydrophobic acrylic) and haptic design (one-piece and three-piece open loop) of sharp optic edge intraocular lenses (IOL) on anterior capsule opacification (ACO) and capsulorrhexis contraction. DESIGN: Randomized, controlled, double-blind clinical trial with intraindividual comparison. METHODS: This study was performed at the Department of Ophthalmology, Medical University of Vienna, Austria, and comprised 210 eyes of 105 patients with bilateral age-related cataract. In group 1 (n = 53 patients), a three-piece acrylic IOL was compared with a three-piece silicone IOL. In group 2 (n = 52 patients), the three-piece acrylic IOL was compared with the one-piece acrylic IOL. One year after the operation, standardized digital slit-lamp images of ACO were taken; 1 week and 1 year after the operation, digital retroillumination images were taken to assess capsulorrhexis size. The intensity of ACO was graded objectively (score, 0% to 100%), and the capsulorrhexis area (square millimeters) was determined objectively. RESULTS: One year after surgery, the mean ACO score was 21% for the acrylic and 20% for the silicone IOL (P = .4) in group 1 and 18% for both the three-piece and one-piece acrylic IOLs (P = .87) in group 2. Concerning the amount of capsulorrhexis contraction, there was no significant difference between the IOL types that were evaluated in this study (after Bonferroni-Holm correction, P > .05). CONCLUSION: In the hydrophobic sharp optic edge IOLs that were examined, neither the optic material nor the haptic design had an influence on the amount of ACO or capsulorrhexis contraction.

Effect of anterior capsule polishing on the posterior capsule opacification-inhibiting properties of a sharp-edged, 3-piece, silicone intraocular lens: three- and 5-year results of a randomized trial.

PURPOSE: To evaluate the long-term effects of anterior capsule polishing on regeneratory posterior capsule opacification (PCO), anterior capsule opacification (ACO), and fibrotic PCO with a silicone intraocular lens (IOL) with sharp optic edges. SETTING: Department of Ophthalmology, Medical University of Vienna, Vienna, Austria. METHODS: This prospective bilateral randomized patient- and examiner-masked clinical trial comprised 130 eyes of 65 patients with bilateral age-related cataract. All eyes had implantation of a 3-piece silicone IOL with a truncated, sharp-edged optic (CeeOn Edge 911A, Advanced Medical Optics). In 1 eye, the anterior capsule was extensively polished using an aspiration curette after phacoemulsification and cortex aspiration. Regenerative PCO was quantified objectively, while ACO and fibrotic PCO were graded subjectively 1, 2, 3, and 5 years postoperatively. RESULTS: The mean ACO score was significantly lower in the eyes in which the anterior capsule had been polished (1 year, P<.02; 2 years, P<.03; 3 years, P<.01; 5 years, P<.01). The mean difference in regeneratory PCO and fibrotic PCO scores between the 2 groups was not statistically significant. CONCLUSIONS: Three years after cataract surgery, eyes in which the anterior capsule had been polished had significantly less ACO. However, polishing did not lower PCO intensity when a sharp-edged CeeOn 911A IOL was implanted in the bag. Although results indicate that anterior capsule polishing may enhance the development of regeneratory PCO, this trend did not reach statistical significance.

Effect of optic material on posterior capsule opacification in intraocular lenses with sharp-edge optics: randomized clinical trial.

PURPOSE: Comparison of the intensity of posterior capsule opacification (PCO) between a silicone intraocular lens (IOL) and a hydrophobic acrylic IOL, both of them 3-piece and open-loop and having truncated optics with sharp edges. DESIGN: Randomized, controlled, patient- and examiner-masked trial with intrapatient comparison. PARTICIPANTS AND CONTROLS: One hundred six eyes of 53 patients with age-related bilateral cataract. METHODS: Each patient had cataract surgery in both eyes and received a silicone IOL in one eye and a hydrophobic acrylic IOL in the fellow eye. Follow-up examinations were at 1 and 3 years after surgery. The patients were examined at the slit lamp, visual acuity (VA) was assessed, and standardized high-resolution digital retroillumination images of the posterior capsule were taken. The amount of PCO was assessed subjectively at the slit lamp and objectively using automated image analysis software. Data of 56 eyes of 28 patients, who were examined at each follow-up, were analyzed. MAIN OUTCOME MEASURE: Posterior capsule opacification intensity at 3 years as measured with automated image analysis. RESULTS: At 1 and 3 years after surgery, PCO did not differ between the silicone (1.6 and 1.9 [image analysis scores, 0-10 scale], respectively) and acrylic IOLs (1.7 and 2.2) (P > 0.24). Furthermore, there was no significant difference in best-corrected VA, rhexis/IOL overlap, capsular folds, and amount of anterior capsule opacification during the follow-up period. In each group, one neodymium:yttrium-aluminum-garnet (YAG) laser capsulotomy was performed during the entire study duration. CONCLUSION: Silicone and hydrophobic acrylic are similarly effective in inducing the PCO-inhibiting effect of a rectangular, sharp optic edge. Three years after surgery, the PCO intensity and the YAG rate were low with both IOL models.

Long-term effect of sharp optic edges of a polymethyl methacrylate intraocular lens on posterior capsule opacification: a randomized trial.

PURPOSE: To compare the posterior capsule opacification (PCO) inhibiting effect of a 3-piece polymethyl methacrylate (PMMA) intraocular lens (IOL) with a sharp optic edge design with that of the round-edged version of the same IOL during a 5-year period. DESIGN: Randomized patient- and examiner-masked clinical trial with intraindividual comparison. PARTICIPANTS: Thirty-two patients with bilateral age-related cataract (64 eyes). METHODS: Each study patient had phacoemulsification cataract surgery in both eyes and received a sharp optic edge PMMA IOL in one eye and a round optic edge PMMA IOL in the fellow eye (both by Dr Schmidt in Germany). Follow-up examinations were at 1 week, 1 month, 1 year, 3 years, and 5 years. Digital retroillumination images were taken from each eye. The amount of posterior capsule opacification was assessed objectively by means of automated image analysis software (Automated Quantification of After-Cataract) at 1 year, 3 years, and 5 years after surgery. MAIN OUTCOME MEASURE: Posterior capsule opacification score: 0-10. RESULTS: The sharp optic edge IOL showed significantly less regeneratory and fibrotic PCO at 1 year, 3 years, and 5 years after surgery. The mean AQUA PCO score was 5.12 for the round-edge and 2.49 for the sharp-edge IOL (scale, 0-10; P<0.001) at 5 years. The mean difference among patients for the PCO score in the eye implanted with the sharp optic edge versus the score in the eye with the round optic edge was 2.83 at 5 years (95% confidence interval, 1.66-4.00). Due to the large number of neodymium:yttrium-aluminum-garnet laser capsulotomies that were performed (12 in the round-edge group and 4 in the sharp-edge group), there was no significant difference in visual acuity between both groups at any time point. CONCLUSIONS: Compared with the round-edge version, the sharp optic edge design of a 3-piece PMMA IOL led to significantly less PCO at 1 year, 3 years, and 5 years after surgery. However, the sharp optic edge did not lead to complete PCO prevention during this follow-up period. This finding has implications for the design of PMMA IOLs used for cataract surgery, especially in the developing world.

Long-term efficacy of adding a sharp posterior optic edge to a three-piece silicone intraocular lens on capsule opacification: five-year results of a randomized study.

PURPOSE: To compare the intensity of capsule opacification with the sharp and the round optic edge variant of an open-loop hydrophobic silicone intraocular lens (IOL). DESIGN: Randomized, controlled, double-blind clinical trial with intraindividual comparison. METHODS: Fifty-one patients with bilateral age-related cataract were included (102 eyes). Each patient had had cataract surgery in both eyes and received a Microsil IOL with a sharp optic edge design (model S) in one eye and a Microsil IOL with a round optic edge design (model R) in the fellow eye. Both IOLs had an identical haptic design (nonangulated polymethylmethacrylate) and silicone optic material. The patients were examined at the slit lamp, best-corrected visual acuity was assessed, and standardized high-resolution digital retroillumination images of the posterior capsule were taken 5 years after surgery. The intensity of regeneratory posterior capsule opacification (rPCO), fibrotic PCO (fPCO), and anterior capsule opacification (ACO) was assessed subjectively at the slit lamp, and of rPCO, objectively using automated image analysis software (AQUA). The need for an Nd:YAG laser capsulotomy (Nd:YAG-LCT) was noted. RESULTS: The mean AQUA PCO score was 1.2 for the model S and 2.4 for the model R lens (P = .001). The model S lens also led to less peripheral fPCO (P = .003). Concerning ACO, there was no significant difference between both IOL groups (P = .72). Whereas no capsulotomy was required with the model S, four cases (16%) had been performed in the model R group. CONCLUSION: Five years postoperatively, the sharp-edged silicone IOL showed less rPCO and fPCO than the round-edged IOL. However, regarding ACO, there was no significant difference between both IOL styles.

Influence of optic edge design, optic material, and haptic design on capsular bend configuration.

PURPOSE: To assess and classify capsular bend configuration at the optic rim and its association with posterior capsule (PCO) and anterior capsule opacification (ACO) and capsulorhexis contraction with various intraocular lenses (IOLs). SETTING: Department of Ophthalmology, Medical University of Vienna, Vienna, Austria. METHODS: A total of 659 post-cataract surgery eyes of 370 patients from different prospective randomized studies were evaluated. All eyes had standardized phacoemulsification surgery with implantation of an IOL in the capsular bag. The IOLs had a sharp or round optic edge design and were made of silicone, acrylic, or poly(methyl methacrylate) optic materials. One year postoperatively, the configuration of the capsular bend at the optic rim was assessed at the slitlamp, and standardized slitlamp images of ACO and fibrotic PCO were taken. One week, 1 year, and 3 years postoperatively, digital retroillumination images were taken for objective quantification of regeneratory PCO and the capsulorhexis area. The outcome measures were the type of capsular bend configuration, ACO score (0% to 100%), regeneratory PCO score (0 to 10), fibrotic PCO score (0 to 3), and amount of capsulorhexis contraction (mm(2)). RESULTS: Four main types of capsular bend configuration were classified: parallel, "Y," right angle, and wrapping. The right-angle type was observed in the most cases (52%). Eyes with a wrapping capsular bend configuration had significantly less PCO, more capsulorhexis contraction, and more ACO than eyes with the other configurations. Wrapping capsule configuration was seen most often (55%) in round-edged silicone IOLs that had a thin optic rim. CONCLUSION: The design and material of IOLs influenced the long-term capsular bend configuration at the optic rim. The right-angle type was the most common capsular bend configuration. Intraocular lenses with silicone optic material and a thin optic rim caused a wrapping capsule configuration and resulted in more capsulorhexis contraction and ACO, but less PCO.

Effect of anterior capsule polishing on posterior capsule opacification and neodymium:YAG capsulotomy rates: three-year randomized trial.

PURPOSE: To compare the long-term effect of extensive polishing and nonpolishing of the anterior lens capsule on posterior capsule opacification (PCO) and neodymium:YAG (Nd:YAG) capsulotomy rates. SETTING: Department of Ophthalmology, Medical University of Vienna, Vienna, Austria. METHODS: This prospective randomized bilateral double-masked study included 108 eyes of 54 consecutive patients with age-related cataract. Following phacoemulsification, 3-piece intraocular lenses (IOLs) with round-edged silicone optics were implanted. Patients received an Allergan SI-40 IOL with a truncated, round optic edge or a Domilens Silens6 IOL with a fully round optic edge. Patients were randomly assigned to have extensive anterior capsule polishing with the Menapace aspiration curette or no treatment in the first eye; the second eye received the opposite treatment. Digital retroillumination images were taken at 1 week, 1 year, and 3 years, and Nd:YAG capsulotomy rates were evaluated. Posterior capsule opacification was objectively scored using automated image analysis software (AQUA) or estimated based on clearly defined assumptions if a capsulotomy had been performed. RESULTS: Thirty-nine patients (78 eyes) concluded the study. Three-year PCO scores after polishing did not differ significantly (P>.05). However, 21 polished eyes (53.8%) required Nd:YAG laser capsulotomy compared with 14 nonpolished eyes (35.9%). The mismatch between PCO scores and Nd:YAG rates resulted from a change in PCO morphology that is not detected by scoring methods based on retroillumination photography but is visually disturbing to patients. CONCLUSIONS: Polishing the anterior capsule was effective in reducing fibrotic opacification but ineffective in reducing regeneratory opacification. Changes in regeneratory PCO morphology not picked up by retroillumination photography increased the need for Nd:YAG laser capsulotomy.

Long-term effect of optic edge design in an acrylic intraocular lens on posterior capsule opacification.

PURPOSE: To compare the posterior capsule opacification (PCO) inhibiting effect of the sharp posterior optic edge design of the Sensar OptiEdge AR40e intraocular lens (IOL) with that of the double-round edge design of the Sensar AR40 IOL over a period of 3 years. SETTING: Department of Ophthalmology, Medical University of Vienna, Vienna, Austria. METHODS: Fifty-three patients with bilateral age-related cataract (106 eyes) were included in this randomized prospective bilateral patient- and examiner-masked clinical trial with intraindividual comparison. Each study patient had cataract surgery in both eyes and received a Sensar AR40 IOL (anterior and posterior round optic edges) in 1 eye and a Sensar OptiEdge AR40e IOL (round anterior and sharp posterior optic edge) in the other eye. Follow-up examinations were at 1 week, 1 and 6 months, and 1, 2, and 3 years. Digital retroillumination images were taken of each eye. The amount of PCO was assessed subjectively at the slitlamp and objectively using automated image-analysis software (AQUA) 1, 2, and 3 years after surgery. RESULTS: The sharp-edged AR40e lens showed significantly less regeneratory and fibrotic PCO 1, 2, and 3 years after surgery. The mean AQUA PCO score was 2.18 for the AR40 and 1.00 for the AR40e lens after 1 year; 2.94 and 1.56 after 2 years, and estimated at 3.13 and 1.77, respectively, after 3 years (scale 0 to 10; P<.001). The neodymium:YAG laser capsulotomy rate was significantly higher in the AR40 group. The AR40e lens also led to less peripheral fibrotic PCO. There was no significant difference in complaints concerning edge glare between the groups. CONCLUSION: Compared with the AR40 IOL, the sharp posterior optic edge design of the Sensar OptiEdge AR40e IOL led to significantly less PCO 1, 2, and 3 years postoperatively. In contrast with most past studies on PCO-preventative factors, this study varied only 1 parameter, namely the optic edge design, and the main outcome measure (PCO) was assessed with an objective image-analysis system.

Comparison of posterior capsule opacification between the 1-piece and 3-piece Acrysof intraocular lenses: two-year results of a randomized trial.

PURPOSE: To compare intensity of posterior capsule opacification (PCO) between the 1-piece and 3-piece haptic designs of an open-loop hydrophobic acrylic intraocular lens (IOL). DESIGN: A randomized, patient- and examiner-masked clinical trial with intraindividual comparison. PARTICIPANTS: Fifty-two patients with bilateral age-related cataract (104 eyes). METHODS: Each patient had cataract surgery in both eyes and received a 1-piece Acrysof IOL in one eye and a 3-piece Acrysof IOL in the fellow eye. Follow-up examinations were at 1 week, 1 month, 6 months, 1 year, and 2 years. Patients were examined at the slit lamp, visual acuity (VA) was determined, and standardized high-resolution digital retroillumination images of the posterior capsule were taken. The intensity of PCO was assessed subjectively at the slit lamp and objectively using automated image analysis software. MAIN OUTCOME MEASURE: Posterior capsule opacification score (scale, 0-10). RESULTS: There was no significant difference between IOL styles in best-corrected VA, rhexis/IOL overlap, capsular folds, and amount of anterior capsule opacification during the follow-up period. One year postoperatively, the amount of regeneratory PCO was higher for the 1-piece Acrysof eyes (image analysis software score: 1.3) than for the 3-piece Acrysof eyes (score: 0.9; P = 0.002). However, 2 years postoperatively, there was no significant difference between the 2 IOL styles (1-piece: 1.5; 3-piece: 1.3; P = 0.3). Neodymium:yttrium-aluminum-garnet capsulotomy was not performed in the study. CONCLUSION: One year postoperatively, the 1-piece Acrysof showed slightly more regeneratory PCO than the 3-piece Acrysof. However, 2 years postoperatively, the barrier effect of the 1-piece design was comparable to that of the 3-piece haptic design, with low PCO intensity.