Results of the United States Food and Drug Administration Clinical Trial of the CustomFlex Artificial Iris.

PURPOSE: To evaluate safety and efficacy of a custom-manufactured artificial iris device (CustomFlex Artificial Iris; HumanOptics AG) for the treatment of congenital and acquired iris defects. DESIGN: Multicenter, prospective, unmasked, nonrandomized, interventional clinical trial. PARTICIPANTS: Patients with photophobia, sensitivity secondary to partial or complete congenital or acquired iris defects, or both. METHODS: Eyes were implanted from November 26, 2013, to December 1, 2017, with a custom, foldable artificial iris by 1 of 4 different surgical techniques. Patients were evaluated 1 day, 1 week, and 1, 3, 6, and 12 months after surgery. At each examination, slit-lamp findings, intraocular pressure, implant position, subjective visual symptoms, and complications were recorded. Corrected distance visual acuity (CDVA) and endothelial cell density (ECD) were measured at 3, 6, or 12 months as additional safety evaluations. The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) was used to assess health-related quality of life affected by vision. The Global Aesthetic Improvement Scale was used to assess cosmetic results. MAIN OUTCOME MEASURES: Photosensitivity, glare, visual symptoms, NEI VFQ-25 score, Global Aesthetic Improvement Scale rating, prosthesis-related adverse events, intraocular lens (IOL)-related adverse events, and surgery-related adverse events 12 months after surgery. RESULTS: At the 12-month postoperative examination, a 59.7% reduction in marked to severe daytime light sensitivity (P < 0.0001), a 41.5% reduction in marked to severe nighttime light sensitivity (P < 0.0001), a 53.1% reduction in marked to severe daytime glare (P < 0.0001), and a 48.5% reduction in severe nighttime glare (P < 0.0001) were found. A 15.4-point improvement (P < 0.0001) in the NEI VFQ-25 total score was found, and 93.8% of patients reported an improvement in cosmesis as measured by the Global Aesthetic Improvement Scale 12 months after surgery. No loss of CDVA of > 2 lines related to the device was found. Median ECD loss was 5.3% at 6 months after surgery and 7.2% at 12 months after surgery. CONCLUSIONS: The artificial iris surpassed all key safety end points for adverse events related to the device, IOL, or implant surgery and met all key efficacy end points, including decreased light and glare sensitivity, improved health-related quality of life, and satisfaction with cosmesis. The device is safe and effective for the treatment of symptoms and an unacceptable cosmetic appearance created by congenital or acquired iris defects.

Visual and Patient-Reported Outcomes of a Diffractive Trifocal Intraocular Lens Compared with Those of a Monofocal Intraocular Lens.

PURPOSE: To evaluate the effectiveness and safety of a trifocal intraocular lens (IOL), the TFNT00 (Alcon, Fort Worth, TX), versus a monofocal IOL, the SN60AT (Alcon). DESIGN: Food and Drug Administration-approved, prospective, multicenter, nonrandomized, parallel-group, assessor-masked, confirmatory trial. PARTICIPANTS: Patients enrolled were 22 years of age or older with a diagnosis of bilateral cataract with planned removal by phacoemulsification with a clear corneal incision. METHODS: Consented participants selected their preferred IOL, which was implanted sequentially into each eye of patients meeting eligibility criteria. MAIN OUTCOME MEASURES: The coprimary effectiveness outcomes were mean photopic monocular best-corrected distance visual acuity (BCDVA; 4 m) and distance-corrected near visual acuity (DCNVA; 40 cm) at 6 months after surgery. Secondary effectiveness outcomes included mean monocular distance-corrected intermediate visual acuity (DCIVA; 66 cm) and proportion of participants responding "never" to question 1 of the Intraocular Lens Satisfaction questionnaire (regarding frequency of spectacle use in the past 7 days). Safety outcomes included frequency of "severe" and "most bothersome" visual disturbances. RESULTS: Two hundred forty-three patients underwent cataract surgery with bilateral implantation of the TFNT00 (n = 129) or SN60AT (n = 114) and were followed up for 6 months. Noninferiority of TFNT00 to SN60AT in mean photopic monocular BCDVA (95% upper confidence limit of the difference was <0.1 logarithm of the minimum angle of resolution [logMAR] margin), and superiority in mean photopic monocular DCNVA (difference of 0.42 logMAR; P < 0.001) and DCIVA (difference of 0.26 logMAR; P < 0.001) were demonstrated. The proportion of patients never requiring glasses overall was superior for TFNT00 versus SN60AT (80.5% and 8.2%, respectively). Starbursts, halos, and glare were the most frequently rated severe symptoms with TFNT00; however, less than 5% of patients were very bothered at month 6. CONCLUSIONS: The TFNT00 exhibited superior monocular DCNVA and DCIVA to a spherical monofocal IOL, with comparable monocular BCDVA. Binocular visual acuity was 20/25 or better for distance to near (+0.5 D to -2.5 D), resulting in high levels of spectacle independence. Less than 5% of patients were very bothered by the photic visual disturbances associated with the TFNT00 at 6 months after surgery.

A large retrospective database analysis comparing outcomes of intraoperative aberrometry with conventional preoperative planning.

PURPOSE: To evaluate differences between the absolute prediction error using an intraoperative aberrometry (IA) device for intraocular lens (IOL) power determination versus the error that would have resulted if the surgeon's preoperative plan had been followed. SETTING: Multiple centers in the United States. DESIGN: Retrospective analysis of data collected using an IA device. METHODS: The database information was limited according to predetermined inclusion/exclusion criteria. Primary endpoints included the difference between mean and median absolute prediction error with IA use versus preoperative calculation, and the percentage of cases were compared when the prediction error was 0.5 diopters (D) or less. RESULTS: A total of 32 189 eyes were analyzed. The IA mean absolute prediction error was lower than the preoperative calculation, 0.30 D ± 0.26 (SD) versus 0.36 ± 0.32 D (P < .0001). The aberrometry absolute median prediction error was lower than the preoperative calculation, 0.24 D versus 0.29 D (P < .0001). There was a significantly greater percentage of eyes with an aberrometry absolute prediction error of 0.5 D or less than eyes with a preoperative absolute prediction error of 0.5 D or less (26 357 [81.9%] of 32 189 vs. 24 437 [75.9%] of 32 189, P < .0001). In addition, in those cases in which power of the IOL implanted was different than the preoperatively planned IOL power, significantly more eyes had an aberrometry absolute prediction error of 0.5 D or less (10 385 [81.3%] of 12 779 vs. 8794 [68.8%] of 12 779, P < .0001). CONCLUSIONS: In a database of more than 30 000 eyes, calculations incorporating IA outperformed preoperative calculations. The difference was more pronounced in those cases in which the preoperatively planned IOL power was different than the power of the IOL implanted.

Comparison of stability between a modular intraocular lens system and a single-piece hydrophobic acrylic intraocular lens.

PURPOSE: To compare the movement of a modular intraocular lens (IOL) with that of a standard single-piece hydrophobic acrylic IOL in a human cadaver eye perfusion model. SETTING: Department of Ophthalmology, University of Colorado, Aurora, Colorado, USA. DESIGN: Experimental study. METHODS: Eight phakic human donor eyes of 4 patients had standard phacoemulsification with lens removal. One of 2 IOLs was then implanted in the capsular bag: a modular IOL (Harmoni) or a standard single-piece IOL (Acrysof SN60). Each globe was connected to a programmable perfusion pump with an in-line pressure transducer. Ultrasound biomicroscopy (UBM) was used to evaluate the anterior chamber depth (ACD) in each eye, measuring from the posterior cornea to the anterior surface of the optic at an intraocular pressure (IOP) of 5 mm Hg, 10 mm Hg, 20 mm Hg, and 30 mm Hg. Five consecutive measurements were recorded for all eyes at each pressure, and the results were averaged. RESULTS: There was significantly less movement in eyes with the modular IOL than in eyes with the single-piece IOL. The mean position of the modular IOL varied from a minimum of 0.03 mm to a maximum of 0.07 mm, and the mean position of the single-piece IOL varied from a minimum of 0.26 mm to a maximum of 0.87 mm (P = .002). CONCLUSIONS: The modular IOL showed less movement with changes in IOP than a standard single-piece IOL. Improved IOL stability might allow more accuracy in determining the effective lens position and hence improve the predictability of the refractive target. FINANCIAL DISCLOSURE: Proprietary or commercial disclosures are listed after the references.

Continuous Curvilinear Capsulorhexis Performed With the VERUS Ophthalmic Caliper.

PURPOSE: To compare size, circularity, and centration outcomes of continuous curvilinear capsulorhexis (CCC) performed with or without assistance from the VERUS ophthalmic caliper (Mile High Ophthalmics, Denver, CO). METHODS: This was a multicenter retrospective consecutive case controlled series review. RESULTS: Data from 40 consecutive cases using the VERUS device for CCC were compared to 40 consecutive cases with standard manual CCC. VERUS-assisted CCC size, circularity, and centration were closer to target compared to that of manual only procedures (P < .05). The average time from initiation to completion of the capsulotomy was shorter with manual (40 ± 11 seconds) compared to VERUS-assisted (71 ± 13 seconds) cases (P < .0001). CONCLUSIONS: The VERUS ophthalmic caliper is effective at improving size, circularity, and centration of the CCC in a time-efficient manner when compared to manual procedures performed without VERUS guidance. [J Refract Surg. 2016;32(10):654-658.].

Intraoperative aberrometry versus standard preoperative biometry and a toric IOL calculator for bilateral toric IOL implantation with a femtosecond laser: One-month results.

PURPOSE: To compare astigmatic outcomes in patients with bilateral cataracts having toric intraocular lens (IOL) implantation with intraoperative aberrometry measurements in 1 eye and standard power calculation and a toric IOL calculator with inked axis marking in the contralateral eye. SETTING: Twelve sites in the United States. DESIGN: Prospective cohort study. METHODS: The eye with the more visually significant cataract was randomized to intraoperative aberrometry measurements (Ocular Response Analyzer with Verifeye) or standard preoperative biometry and use of a toric calculator with the contralateral eye automatically assigned to the other group. The primary effectiveness outcome was the proportion of eyes with a postoperative refractive astigmatism of 0.50 diopter (D) or less at 1 month. RESULTS: Of the 130 patients (260 eyes) enrolled, 124 (248 eyes) were randomized; 121 (242 eyes) completed the trial. The percentage of eyes with astigmatism of 0.50 D or less at 1 month was higher in the intraoperative aberrometry group than in the standard group (89.2% versus 76.6%) (P = .006). The mean postoperative refractive astigmatism was lower in the intraoperative aberrometry group (0.29 D ± 0.28 [SD] versus 0.36 ± 0.35 D) (P = .041). Secondary effectiveness endpoints, including manifest refraction spherical equivalent prediction error, uncorrected distance visual acuity, and corrected distance visual acuity, were similar. CONCLUSIONS: Compared with standard methods, the use of the intraoperative aberrometry system increased the proportion of eyes with postoperative refractive astigmatism of 0.50 D or less and reduced the mean postoperative refractive astigmatism at 1 month. Other efficacy outcomes were similar. FINANCIAL DISCLOSURES: Drs. Woodcock, Lehmann, and Cionni are consultants to Alcon Laboratories, Inc. Dr. Breen is an employee of Alcon Laboratories, Inc. Dr. Scott has no financial or proprietary interest in any material or method mentioned.

Subluxated cataract lens surgery using sutured segments or rings and implantation of toric intraocular lenses.

PURPOSE: To evaluate the intraoperative performance and postoperative outcomes of toric intraocular lens (IOL) with suture ring implantation in adult patients with subluxated lenses. SETTING: Department of Ophthalmology, Kaiser Permanente, Santa Clara, California, and the Eye Institute of Utah, Salt Lake City, Utah, USA. DESIGN: Retrospective case review. METHODS: Eyes with subluxated cataractous lenses and preoperative corneal astigmatism having toric IOL implantation with a sutured ring or segment were studied. Preoperative and postoperative analyses included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), and cylindrical power postoperatively and 3, 6, and 12 months postoperatively. RESULTS: Twenty-one eyes of 15 patients were studied. The median follow-up was 14.6 months. The mean CDVA at the final follow-up (0.10 logMAR ± 0.15 [SD]) was significantly improved from the mean preoperative CDVA (0.73 ± 0.40 logMAR). Postoperative cylindrical power was significantly improved in all patients (mean reduction in astigmatism 2.37 ± 1.46 diopters). Patients who required postoperative enhancement had anterior laser capsulotomy for bilateral capsule phimosis (2 eyes), photorefractive keratectomy (1 eye), pupilloplasty (1 eye), and posterior laser capsulotomy (2 eyes). CONCLUSION: Cataract removal and implantation of a toric IOL combined with a sutured ring or segment capsule stabilizing device was a safe and efficacious long-term solution for patients with subluxated cataract lenses and corneal astigmatism.

Clinical study using a new phacoemulsification system with surgical intraocular pressure control.

PURPOSE: To compare cumulative dissipated energy (CDE), aspiration fluid used, and aspiration time during phacoemulsification cataract extraction using 2 surgical configurations. SETTING: Two clinical sites in the United States and 1 in Spain. DESIGN: Prospective randomized clinical case series. METHODS: For each patient, the first eye having surgery was randomized to the active-fluidics configuration (Centurion Vision System with Active Fluidics, 0.9 mm 45-degree Intrepid Balanced tip, and 0.9 mm Intrepid Ultra infusion sleeve) or the gravity-fluidics configuration (Infiniti Vision System with gravity fluidics, 0.9 mm 45-degree Mini-Flared Kelman tip, and 0.9 mm Ultra infusion sleeve). Second-eye surgery was completed within 14 days after first-eye surgery using the alternate configuration. The CDE, aspiration fluid used, and aspiration time were compared between configurations, and adverse events were summarized. RESULTS: Patient demographics and cataract characteristics were similar between configurations (100 per group). The CDE was significantly lower with the active-fluidics configuration than with the gravity-fluidics configuration (mean ± standard error, 4.32 ± 0.28 percent-seconds) (P < .001). The active-fluidics configuration used significantly less aspiration fluid than the gravity-fluidics configuration (mean 46.56 ± 1.39 mL versus 52.68 ± 1.40 mL) (P < .001) and required significantly shorter aspiration time (mean 151.9 ± 4.1 seconds versus 167.6 ± 4.1 seconds) (P < .001). No serious ocular adverse events related to the study devices or device deficiencies were observed. CONCLUSION: Significantly less CDE, aspiration fluid used, and aspiration time were observed with the active-fluidics configuration than with the gravity-fluidics configuration, showing improved surgical efficiency. FINANCIAL DISCLOSURES: Drs. Solomon and Cionni are consultants to Alcon Research, Ltd., and received compensation for conduct of the study. Dr. Lorente received compensation for clinical work in the study. Mr. Fanney is an employee of Alcon Research, Ltd.

Evaluating Red Reflex and Surgeon Preference Between Nearly-Collimated and Focused Beam Microscope Illumination Systems.

PURPOSE: To evaluate the intensity and stability of the red reflex produced by ophthalmic surgical microscopes with nearly-collimated versus focused illumination systems and to assess surgeon preference in a simulated surgical setting. METHODS: This two-part evaluation consisted of postproduction surgical video analysis of red reflex intensity and a microscope use and preference survey completed by 13 experienced cataract surgeons. Survey responses were based on bench testing and experience in a simulated surgical setting. A microscope with nearly-collimated beam illumination and two focused beam microscopes were assessed. RESULTS: Red reflex intensity and stability were greater with the nearly-collimated microscope illumination system. In the bench testing survey, surgeons reported that the red reflex was maintained over significantly greater distances away from pupillary center, and depth of focus was numerically greater with nearly-collimated illumination relative to focused illumination. Most participating surgeons (≥64%) reported a preference for the microscope with nearly-collimated illumination with regard to red reflex stability, depth of focus, visualization, surgical working distance, and perceived patient comfort. CONCLUSIONS: The microscope with nearly-collimated illumination produced a more intense and significantly more stable red reflex and was preferred overall by more surgeons. TRANSLATIONAL RELEVANCE: This is the first report of an attempt to quantify red reflex intensity and stability and to evaluate surgically-relevant parameters between microscope systems. The data and methods presented here may provide a basis for future studies attempting to quantify differences between surgical microscopes that may affect surgeon preference and microscope use in ophthalmic surgery.

All about capsular tension rings.

PURPOSE OF REVIEW: To discuss capsular tension devices and recent evidence regarding their use. RECENT FINDINGS: The capsular tension ring, modified capsular tension ring, and capsular tension segment are well established tools for use during phacoemulsification when zonular instability is present. Recent research has provided additional evidence of their benefits in decreasing intraoperative and postoperative complications. SUMMARY: Endocapsular support devices allow for cataract surgery success in the setting of zonular instability.

A survey of potential and previous cataract-surgery patients: what the ophthalmologist should know.

OBJECTIVE: This study utilized a phone survey to characterize patient perceptions of cataract surgery and the manner in which the ophthalmologist contributes to the patient's understanding in electing cataract surgery. PATIENTS AND METHODS: Calls were made from a randomized membership list of the American Association of Retired Persons until 1,000 respondents 50 years of age or older had been recruited. Three groups were recruited: persons with no prior diagnosis of cataracts, persons diagnosed with cataracts but who had not had surgery, and persons who had had cataract surgery on both eyes within the past 5 years. A series of fixed-choice and open-ended questions was then presented to qualified participants. Questions related to vision, quality of life, and the understanding and perceptions of cataract surgery. RESULTS: Two-thirds of respondents reported having frequent eye examinations. More than half indicated that they had discussed cataract surgery with an eye doctor, most often with an ophthalmologist. They reported that the benefits of surgery were most often mentioned (68%), but lens options were infrequently mentioned (39%). Of those who had had surgery, 81% elected to do so on the advice of their health care professional. About 85% of respondents who had had surgery felt well educated about the procedure, though only 75% felt they understood their lens and vision options. Three-quarters of those who had had cataract surgery wished they had had the surgery sooner, and reported that they were enjoying life more after surgery. CONCLUSION: The ophthalmologist plays an important role in preparing patients for cataract surgery. Discussing both the timing of the surgery and the patient's lens options are critical for appropriate care; the survey results suggest room for improvement in this regard. Respondents reported they wished they had had surgery sooner, based primarily on their improved quality of life postoperatively.

Ab externo scleral fixation of intraocular lens.

UNLABELLED: We describe an ab externo technique that facilitates IOL scleral fixation and reduces the risk associated with previous ab externo scleral fixation techniques. This technique uses a microvitreoretinal blade and an internal limiting membrane forceps to create sclerotomies and retrieve the suture, respectively. FINANCIAL DISCLOSURE: Dr. Cionni is a consultant to Morcher GmbH, Stuttgart, Germany. Dr. Crandall is a consultant to Alcon Laboratories, Inc., Ft. Worth, Texas, USA. No other author has a financial or proprietary interest in any material or method mentioned.

Length and frequency of intraoperative occlusive events with new torsional phacoemulsification software.

PURPOSE: To evaluate the efficiency profile of new torsional phacoemulsification software. SETTING: Eye Institute of Utah, Salt Lake City, Utah, USA. DESIGN: Comparative case series. METHODS: Routine cataract surgeries were performed using standard torsional (Ozil) and new torsional (Ozil IP) software. The new software uses occasional pulses of longitudinal energy that are operator specified and system controlled to manage potential occlusion. The new software was compared with the previous standard software, which did not include this option. The video monitor system was recorded in high definition. Measurement of cumulative dissipated energy, balanced salt solution use, and amount of time spent in occlusion were measured in a frame-by-frame review of the recorded videos. Data were categorized for analysis by software group and cataract grade (1 to 4). RESULTS: The study comprised 59 eyes that had cataract removal using the new torsional software and 59 eyes using the standard torsional software. Cumulative dissipated energy was not statistically significantly different between the 2 groups. Balanced salt solution use, time spent in occlusion, and the mean longest continuous occlusion were significantly lower with the new torsional software; these differences were greater as the cataract grade increased. CONCLUSIONS: The new torsional software significantly decreased occlusion time and balanced salt solution use over standard torsional software, particularly with denser cataracts. The net result was a relatively better safety cataract surgery profile. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.

Multifocal iris sphincter ruptures: new sign of the lens-iris diaphragm retropulsion syndrome.

We describe the case of a 78-year-old highly myopic woman who had bilateral phacoemulsification with posterior chamber intraocular lens implantation. During surgery, the anterior chamber was extremely deep and the pupil was excessively dilated, consistent with lens-iris diaphragm retropulsion syndrome (LIDRS). Subsequent biomicroscopy revealed multifocal iris sphincter ruptures, a new finding associated with LIDRS.

Functional outcomes after bilateral implantation of apodized diffractive aspheric acrylic intraocular lenses with a +3.0 or +4.0 diopter addition power Randomized multicenter clinical study.

PURPOSE: To evaluate functional outcomes after bilateral implantation of apodized diffractive aspheric acrylic intraocular lenses (IOLs) with a +3.0 or +4.0 diopter (D) addition (add) power. SETTING: Twelve study centers in the United States. METHODS: This randomized patient-masked parallel-group 6-month follow-up study comprised patients having bilateral cataract extraction with implantation of an AcrySof IQ ReSTOR SN6AD3 IOL with a +4.0 D add power (+4.0 D group) or an AcrySof IQ ReSTOR SN6AD1 IOL with a +3.0 D add power (+3.0 D group) (both IOLs, Alcon, Inc.). Visual acuity, defocus testing, patient-reported outcomes, and safety measures were assessed. RESULTS: Of the 279 patients, 141 were in the +3.0 D group and 138 were in the +4.0 D group. Binocular distance-corrected intermediate visual acuity was statistically significantly better in the +3.0 D group than in the +4.0 D group (P<.0001); there was no difference in binocular near or distance visual acuity. There were no statistically significant differences in visual disturbances between the 2 groups. Patients in both groups reported excellent overall spectacle independence, near visual function, and satisfaction with the IOLs. CONCLUSIONS: Intermediate vision at a mean reading distance of approximately 40 cm was better with the aspheric IOL with a +3.0 D add than with the aspheric IOL with a +4.0 D add, as shown by the near peak in the mean binocular defocus curve; near and distance acuity were similar between the 2 IOLs. Patients reported excellent overall quality of vision, spectacle independence, and satisfaction.

Visual outcome comparison of unilateral versus bilateral implantation of apodized diffractive multifocal intraocular lenses after cataract extraction: prospective 6-month study.

PURPOSE: To evaluate the visual outcomes and patient satisfaction after unilateral implantation or stepwise bilateral implantation of an apodized diftractive multifocal intraocular lens (IOL). SETTING: Private practice, Cincinnati, Ohio, USA. METHODS: Patients requiring cataract surgery in 1 eye were recruited. AcrySof ReSTOR IOLs were implanted in 1 eye of patients with phakic contralateral eyes, patients with contralateral monofocal IOLs, and patients with a contralateral multifocal IOL of the same model. Six months postoperatively, patients were assessed for visual acuity (31.0 cm, 50.0 cm, 4.0 m), contrast sensitivity, and stereopsis. Patients were surveyed for visual disturbances and lifestyle visual quality. RESULTS: Of unilateral multifocal IOL patients, 75% were satisfied with their vision (score 7.3 out of 10) and a majority (56% multifocal-phakic, 65% multifocal-monofocal) achieved spectacle independence. These values were slightly lower than values for bilateral multifocal patients (92% satisfied, 77% spectacle independent), but not at a statistically significant level. Mean overall patient satisfaction was statistically significantly different: 8.9 for bilateral patients versus 7.3 for unilateral patients. Objectively, significant differences favored bilateral implantation over unilateral implantation for stereopsis, uncorrected near visual acuity, and best corrected near and intermediate visual acuities. Contrast sensitivity was similar between groups in most cases. The incidence of halos was lower in unilateral patients (57%) than in bilateral patients (77%), although the difference did not reach statistical significance. CONCLUSION: Although unilateral implantation of a multifocal IOL provided patients with high levels of spectacle freedom and good visual acuity without compromising contrast sensitivity, overall clinical results favored bilateral implantation.

[Evaluation of the modified capsular tension ring in cases of traumatic lens subluxation]. / Avaliação do uso do anel endocapsular modificado em casos de subluxação traumática do cristalino.

PURPOSE: To evaluate the behavior of the modified capsular tension ring (MCTR) in traumatic subluxated cataracts analyzing the visual acuity, centration of the capsular bag, pseudophacodonesis, postoperative follow-up and intra- and postoperative complications. SETTING: Cincinnati Eye Institute, Cincinnati, Ohio, USA. METHODS: Twenty-two eyes of 22 patients with traumatic loss of zonular support had phacoemulsification using PCIOL and MCTR implantation. The preoperative examination included best correct visual acuity (BCVA) and the presence or absence of phacodonesis, lens decentration and vitreous prolapse. The postoperative evaluation included BCVA, the presence of pseudophacodonesis, PCIOL centration, necessity of vitrectomy and other complications. RESULTS: 21 eyes (95.45%) had an improvement in BCVA. The preoperative examination disclosed phacodonesis in 11 eyes (50%) and no eye presented pseudophacodonesis in the postoperative period. Preoperatively, symptomatic decentration was presented by 10 eyes (45.45%) and 22 eyes (100%) had no decentration after surgery. The preoperative examination revealed vitreous prolapse in the anterior chamber in 9 eyes (40.90%). Vitrectomy was required in 11 eyes (50%). CONCLUSIONS: The use of the MCTR resulted in a good centration of the capsular bag and the PC IOL in 22 eyes with traumatic cataract and loss of zonular support.

Avaliação do uso do anel endocapsular modificado em casos de subluxação traumática do cristalino / Evaluation of the modified capsular tension ring in cases of traumatic lens subluxation

OBJETIVO: Avaliar o comportamento do anel modificado de tensão capsular em cataratas traumáticas com subluxação, analisando a acuidade visual, centração do saco capsular, pseudofacodonese, seguimento pós-operatório, e complicações intra e pós-operatórias. LOCAL: Cincinnati Eye Institute, Cincinnati, Ohio, USA. MÉTODOS: Vinte e dois olhos de 22 pacientes com perda traumática de suporte zonular foram submetidos à facoemulsificação utilizando lente intra-ocular de câmara posterior e o implante do anel capsular modificado. O exame pré-operatório incluiu melhor acuidade visual corrigida (MAVC), a presença ou ausência de facodonese, descentração do cristalino e prolapso vítreo. A avaliação pós-operatória incluiu MAVC, presença de pseudofacodonese, centração do implante, necessidade de vitrectomia e outras complicações. RESULTADOS: Vinte e um olhos (95,45 por cento) tiveram melhora da MAVC. O exame pré-operatório revelou facodonese em 11 olhos (50 por cento) e nenhum olho apresentou pseudofacodonese. No exame pré-operatório, a descentração sintomática estava presente em 10 olhos (45,45 por cento). Todos os olhos apresentaram centração do complexo saco capsular/LIO no pós-operatório. Prolapso vítreo foi diagnosticado antes da cirurgia em 9 olhos (40,90 por cento) e a vitrectomia foi necessária em 11 olhos (50 por cento). CONCLUSÃO: O uso do anel modificado de tensão capsular resultou em boa centração do complexo saco capsular/lente intra-ocular nos olhos estudados com catarata traumática e perda de suporte zonular.

PURPOSE: To evaluate the behavior of the modified capsular tension ring (MCTR) in traumatic subluxated cataracts analyzing the visual acuity, centration of the capsular bag, pseudophacodonesis, postoperative follow-up and intra- and postoperative complications. SETTING: Cincinnati Eye Institute, Cincinnati, Ohio, USA. METHODS: Twenty-two eyes of 22 patients with traumatic loss of zonular support had phacoemulsification using PCIOL and MCTR implantation. The preoperative examination included best correct visual acuity (BCVA) and the presence or absence of phacodonesis, lens decentration and vitreous prolapse. The postoperative evaluation included BCVA, the presence of pseudophacodonesis, PCIOL centration, necessity of vitrectomy and other complications. RESULTS: 21 eyes (95.45 percent) had an improvement in BCVA. The preoperative examination disclosed phacodonesis in 11 eyes (50 percent) and no eye presented pseudophacodonesis in the postoperative period. Preoperatively, symptomatic decentration was presented by 10 eyes (45.45 percent) and 22 eyes (100 percent) had no decentration after surgery. The preoperative examination revealed vitreous prolapse in the anterior chamber in 9 eyes (40.90 percent). Vitrectomy was required in 11 eyes (50 percent). CONCLUSIONS: The use of the MCTR resulted in a good centration of the capsular bag and the PC IOL in 22 eyes with traumatic cataract and loss of zonular support.