Ten-year outcomes of congenital cataract surgery performed within the first six months of life.

PURPOSE: To investigate the long-term outcomes of congenital cataract surgery performed within the first 6 months of life. SETTING: 11 ophthalmic surgical sites in Japan. DESIGN: Retrospective chart review. METHODS: Medical charts were retrospectively reviewed for 216 eyes of 121 patients. The age at surgery was 2.9 ± 1.7 months, with follow-up duration 13.0 ± 2.3 years. The cohort consisted of 83 cases with bilateral aphakia, 12 with bilateral pseudophakia, 20 with unilateral aphakia, and 6 with unilateral pseudophakia. RESULTS: Surgical intervention within the critical period of visual system development (10 weeks for bilateral and 6 weeks for unilateral cases) led to significantly better final visual acuity than surgery conducted after this time frame. The incidence of secondary glaucoma was similar between groups while the occurrence of visual axis opacification was more frequent with earlier surgery. A forward stepwise multiple regression analysis revealed that the final visual acuity was significantly associated with laterality of cataract (better outcomes in bilateral cases), phakic status (with pseudophakia outperforming aphakia), presence of systemic and ocular comorbidities, and development of secondary glaucoma. Secondary glaucoma was significantly more prevalent in aphakic eyes than pseudophakic eyes. CONCLUSIONS: In patients with genuine congenital cataract, surgery within the critical period of visual development results in better final visual acuity, albeit with an increased risk of visual axis opacification. The use of IOL with sophisticated surgical techniques shows promise even in congenital cataract surgery.

Long-term surgical outcomes of pediatric cataract-multivariate analysis of prognostic factors.

We assessed the 10-year postoperative outcomes of pediatric cataract patients who underwent surgery at the age of 6 years or younger. A retrospective review of medical charts was conducted for 457 eyes of 277 patients, with the age at surgery averaging 1.3 ± 1.5 years (mean ± SD) and the follow-up duration averaging 12.8 ± 2.4 years (ranging from 10 to 17 years). The cohort included 250 eyes of 125 cases with bilateral aphakia (age at surgery 0.5 ± 0.8 years), 110 eyes of 55 cases with bilateral pseudophakia (1.9 ± 1.6 years), 42 cases with unilateral aphakia (1.1 ± 1.3 years), and 55 cases with unilateral pseudophakia (2.6 ± 1.7). A forward stepwise multiple regression analysis revealed that the best-corrected visual acuity at the final visit was significantly associated with laterality of cataract (with bilateral cases showing better results compared to unilateral cases), presence of systemic comorbidities, presence of ocular comorbidities, development of glaucoma, and phakic status (with better results in the pseudophakia group than the aphakia group). The age at surgery did not significantly affect visual acuity outcomes. A multiple logistic regression analysis demonstrated that the incidence of secondary glaucoma was significantly linked to younger age at surgery, phakic status (higher in aphakic than pseudophakic eyes), and presence of systemic comorbidities. In conclusion, after pediatric cataract surgery, final visual acuity was better in patients with bilateral cataracts, those treated with an intraocular lens, and cases without systemic or ocular comorbidities and secondary glaucoma. The development of secondary glaucoma was linked to younger age at surgery, aphakic status, and presence of systemic comorbidities.

Open-capsule intraocular lens to prevent posterior capsule opacification.

PURPOSE: To develop a single-piece open-capsule intraocular lens (IOL) that can be inserted through a small incision and that prevents posterior capsule opacification (PCO) by expanding the capsule and circulating aqueous humor into the capsular bag. SETTING: Department of Ophthalmology, Dokkyo Medical University, Tochigi, Japan. DESIGN: Experimental study. METHOD: Using the same hydrophobic acrylic material as the NY-60 IOL, a prototype open-capsule IOL was constructed. The IOL has a single optic and 2 haptics, with a 2.8 mm high spacer and holes through which aqueous humor circulates into the capsular bag by separating the anterior capsule from the posterior capsule and expanding the capsule. The open-capsule IOL or NY-60 (as a control group) was inserted in rabbit eyes. Posterior capsule opacification development was evaluated by measuring the thickness of the cell layer at the center of the posterior capsule on histopathologic specimens and statistically comparing the thickness between the open-capsule IOL group and control group. RESULTS: The open-capsule IOL could be inserted through a 3.2 mm corneal incision using a D cartridge. The mean thickness of the cell layer at the center of the posterior capsule was 4.78 µm ± 2.61 (SD) in the open-capsule IOL group and 101.14 ± 25.19 µm in the control group and was significantly smaller in the open-capsule IOL group. CONCLUSION: The prototype single-piece IOL could be implanted through a small incision and prevented PCO by expanding the lens capsule and circulating aqueous humor into the capsular bag.

Effects of optical diameter of intraocular lenses with intrascleral fixation on higher-order aberrations.

BACKGROUND: Intrascleral fixation of an intraocular lens (IOL) is used in eyes that lack capsular support. The aim of the study is to determine whether a larger optical diameter IOL will decrease the higher-order aberrations (HOAs) when the haptics are extended for intrascleral fixation than a smaller diameter IOL. METHODS: Three-piece acrylic IOLs with 6.0 mm optics (X-60, VA-60BBR) and 7.0 mm optics (X-70, VA-70 AD) were fixed at lengths of 13, 14, 15, 16, or 17 mm. A wavefront analyzer was used to measure the HOAs within the central 3.0 and 5.2 mm optic diameter. RESULTS: The astigmatic aberration within the central 5.2 mm was greater than that within the central 3.0 mm for all IOLs. The HOAs increased significantly with an extension of the IOLs with both optical diameters (P < 0.001). The coma aberration within the central 5.2 mm was greater than that within the central 3.0 mm but it did not increase with an extension of the haptics. The astigmatic aberration of the X-60 IOL was significantly greater than that of the X-70 only at an extension of 17 mm. The astigmatic aberration of the VA-70 AD was not significantly different from that of the VA-60BBR. The cylindrical power changed from 0.047 D in the X-60 to 0.118 D in the VA-70 AD when the IOLs were extended from 13 to 17 mm. CONCLUSION: When three-piece IOLs are highly extended for intrascleral fixation, the astigmatic aberration increases significantly. However, IOLs with 7 mm optics do not have less astigmatic and coma aberrations than IOLs with 6 mm optics.

Surgical outcomes of congenital and developmental cataracts in Japan.

PURPOSE: To retrospectively analyze the surgical outcomes of congenital/developmental cataracts in Japan. METHODS: A mail questionnaire was sent to facilities engaged in surgical treatment of congenital cataracts. RESULTS: Twenty-nine facilities reported on 809 eyes of 508 patients with congenital/developmental cataracts. Three hundred fifty-nine eyes underwent intraocular lens implantation (pseudophakia group), while 450 eyes were left aphakic (aphakia group). The average age at surgery was significantly higher in the pseudophakia group (70 ± 53 months) than in the aphakia group (14 ± 24 months) (P < 0.0001). A significantly larger proportion of patients with unilateral cataract (52.0 %) received IOL implantation than did those with bilateral cataracts (42.6 %) (P = 0.0224). The prevalence of associated ocular disorders, such as nystagmus, microcornea, nanophthalmos, and persistent fetal vasculature, was significantly higher in the aphakia group than in the pseudophakia group. Postoperatively, glaucoma developed more frequently in the aphakia group (5.8 %) than in the pseudophakia group (0.7 %) (P = 0.0003). Posterior capsule opacification developed more frequently in the pseudophakic eyes even when both posterior capsulotomy and anterior vitrectomy were performed, especially in patients aged 1 year or younger. Postoperative visual acuity was significantly better in the pseudophakia group than in the aphakia group, both in the unilateral and in the bilateral cases. CONCLUSIONS: Surgeons tended to select IOL implantation, rather than to leave the eye aphakic, in patients who were older at the time of surgery, had fewer coexisting ocular disorders, and suffered from unilateral cataract. Under such circumstances, pseudophakic eyes obtained significantly better postoperative visual acuity than did aphakic eyes.

Changes in higher-order aberrations of intraocular lenses with intrascleral fixation.

AIM: To determine the higher-order aberrations of intraocular lenses (IOLs) that are extended and fixed intrasclerally. METHODS: A computer-aided design system was used to calculate the length of an IOL when it was fixed to the sclera 2 mm posterior to the limbus in a Gullstrand eye model. An acrylic single-piece (SA60AT) or 2 three-piece IOLs (VA-60BBR; X-60) were fixed at lengths of 13, 14, 15 and 16 mm. A wavefront analyser was used to measure the higher-order aberrations within the central 3.0 and 5.2 mm optic diameters. RESULTS: The length of the IOL with the intrascleral fixation was calculated to be 13.9-14.9 mm in the eye model. The astigmatic aberration of the three-piece VA-60BBR and X-60 IOLs increased significantly with an extension of the IOLs within the central 5.2 mm (both p<0.001) but not that of the single-piece SA60AT IOL. The coma aberration of the VA-60BBR IOL increased significantly within the central 5.2 mm with an increase in the extension (p=0.001) but not that of the SA60AT and X-60 IOLs. The astigmatic and coma aberrations were significantly greater within the central 5.2 mm than within the central 3.0 mm for all IOLs (p<0.05). The cylindrical power increased from 0.034 D to 0.082 D with extensions from 13 to 16 mm. CONCLUSIONS: When three-piece IOLs are extended widely for intrascleral fixation, the astigmatic and coma aberrations increase but the degree of change should not alter the postoperative vision appreciably.

A survey of the surgical treatment of congenital and developmental cataracts in Japan.

PURPOSE: To understand the current practice pattern for the surgical treatment of congenital/developmental cataracts in Japan. METHODS: A mail questionnaire was sent to facilities engaged in the surgical treatment of congenital cataracts in Japan. RESULTS: Thirty-four facilities reported their preferred methods for the surgical treatment of congenital cataracts, including data from 809 eyes of 508 patients who had undergone surgery. More than 85% of the respondents answered that they would consider surgery even if the visual prognosis was not promising because of possible form-deprivation amblyopia. The most commonly performed surgical maneuvers were scleral tunnel incision (88.4%), 3.0-mm or smaller incision (78.8%), manual anterior continuous curvilinear capsulorhexis (90.2% success rate), posterior capsulotomy (92.5% for patients aged ≤6 years), anterior vitrectomy by the limbal approach (85.9% for patients aged ≤6 years), and wound closure with sutures (93.2%). Posterior capsulotomy and vitrectomy were not usually performed in patients aged >6 years. Implantation of an intraocular lens (IOL) was mostly indicated in patients aged 2 years or older. Implantation of an acrylic foldable IOL (76.6%) into the capsular bag (89.7%) was the most common practice among the surgeons. CONCLUSIONS: Small incision surgery with implantation of an acrylic foldable IOL into the capsular bag combined with posterior capsulotomy was the preferred surgical treatment of choice for congenital/developmental cataracts.

Clinical characteristics of congenital and developmental cataract undergoing surgical treatment.

PURPOSE: To analyze the clinical characteristics of congenital/developmental cataract undergoing surgery. METHODS: A mail questionnaire was sent to 49 facilities engaged in surgical treatment of congenital cataracts, and data on preoperative clinical features were collected. RESULTS: Twenty nine facilities reported on 864 eyes of 521 patients with congenital/infantile cataract, ranging in age at initial visit from 0 to 18.8 years (2.6 ± 3.3 years, mean ± standard deviation). Among the patients, 65.8 % had bilateral cataracts and 34.2 % were unilaterally affected. Family history was found for 22.4 % of cases, of which 98.1 % were bilateral. Family history was positive for 33.1 % of bilateral and 1.3 % of unilateral cases. The most common main complaint was white pupil for 35.7 % of bilateral cases and 32.7 % for unilateral cases. Concomitant systemic abnormalities were more frequently associated with bilateral cases (31.6 %) than with unilateral cases (16.7 %). Associated ocular diseases, such as strabismus, persistent fetal vasculature, and posterior lenticonus, were more frequently seen among unilateral cases whereas nystagmus was more common among bilateral cases. CONCLUSIONS: Among congenital/developmental cataracts, the ratio of bilateral and unilateral cases was approximately 2:1. Almost all patients with a family history of congenital cataract were bilateral. Initial visits to a physician were rather late, 2.6 years from birth; this should be improved.

[Corneal astigmatism in children with congenital cataract].

PURPOSE: To investigate corneal astigmatism in children with congenital cataract before surgery. MATERIALS AND METHODS: We retrospectively reviewed the charts of 99 eyes of 62 patients (74 paired eyes and 25 single eyes) who had undergone congenital cataract surgery from March, 2000 to April, 2012. The mean age at surgery was 32.1 +/- 26.9 months. All eyes were examined using an autorefract-keratometer. Cases were divided into 3 groups according to the axis of astigmatism (with-the-rule, against-the-rule and oblique astigmatism). RESULT: The mean corneal astigmatism was 2.45 +/- 1.28 diopters (D) (range 0.25-6.87D). The prevalence of corneal astigmatism of 2.0 D or more was 65.7%. The most frequent was astigmatism with-the-rule (83.8%) (mean 2.64 +/- 1.25 D), oblique astigmatism was 11.1% (mean 1.43 +/- 0.98 D), and 5.1% of the cases had astigmatism against-the-rule (mean 1.55 +/- 1.07 D). The mean corneal astigmatism of the eye with cataract (2.46 D) was significantly higher than that of the normal eye (1.66 D) in unilateral cases. CONCLUSIONS: Children with congenital cataract had a high prevalence of large corneal astigmatism > or = 2.00D, that was generally with-the-rule. In the unilateral cataract patients, cataract eyes had higher corneal astigmatism than normal eyes.

Miyake-Apple view of inner side of sclerotomy during microincision vitrectomy surgery.

PURPOSE: To examine the inner surface of the sclerotomy during microincision vitrectomy surgery by Miyake-Apple view. METHODS: The anterior half of porcine eyes was attached to a transparent acrylic plate with cyanoacrylate glue. Then, either a 23-gauge or a 25-gauge trocar-cannula was inserted through the sclera obliquely. The inner surface of the entrance site was observed posteriorly by Miyake-Apple view. These images were compared with the endoscopic view of two patients who underwent vitreous surgery for an epiretinal membrane. RESULTS: When the trocar-cannula was inserted obliquely, the Miyake-Apple view showed that the ciliary epithelium at the sclerotomy site was stretched. When the trocar-cannula was inserted vertically, the ciliary epithelium was folded, and the folds remained even after the trocar was removed. Vitreous strands were seen incarcerated into the sclerotomy site. In human eyes, a folding of the ciliary epithelium was not clearly seen with the endoscopic view but the incarcerated vitreous was seen. CONCLUSION: The Miyake-Apple view provided a precise, in vivo, observation of the inner surface of the entry site. It disclosed the morphological stress on the ciliary epithelium by the sclerotomy.

Perforating eyelid injury extending to the brain stem in a 17-year-old woman: a case report.

INTRODUCTION: This case report describes a patient who had a perforating eyelid injury that extended to the brain stem. CASE PRESENTATION: A 17-year-old Japanese woman complained of decreased vision in her right eye, with severe ocular pain and headaches, after the metal tip of an umbrella struck her upper right eyelid accidentally. Her vision in the right eye decreased to light perception with commotio retinae, intraretinal hemorrhage, and severe lid swelling. Magnetic resonance imaging (MRI) demonstrated edema of the head of the caudate nucleus and putamen, and the edema extended to the hypothalamus. The MRI findings indicated that the umbrella tip had penetrated through the eyelid and the posterior orbital wall. Vision improved to 20/50 in the right eye, with subretinal fibrosis caused by the choroidal rupture. CONCLUSIONS: We recommend that MRI be performed on the orbit and brain in patients who appear to have symptoms that are inconsistent with the observed injury and when a severe orbitocranial injury is suspected.

Inhibition of posterior capsule opacification by a capsular adhesion-preventing ring.

OBJECTIVE: To assess the inhibitory effect of a capsular adhesion-preventing ring (CAPR) that facilitates aqueous humor circulation into the capsular bag on posterior capsule opacification (PCO) formation after cataract surgery. METHODS: After phacoemulsification, a polymethyl methacrylate intraocular lens with (n=5) or without (n=5) a CAPR was implanted in rabbit eyes. The inhibitory effect of the CAPR on PCO formation was assessed by stereoscopic microscopy and histologic examination 8 weeks after surgery. RESULTS: All eyes in which a CAPR was implanted demonstrated remarkably less PCO than the control eyes. Neither anteroposterior capsular adhesion nor regeneration of lens fiber occurred in 2 eyes in the CAPR group. The remaining 3 eyes with a CAPR showed partial capsular adhesion and limited lens fiber regeneration in the resultant closed capsular space. CONCLUSIONS: The CAPR appears to prevent PCO formation by separating the anterior and posterior capsules and allowing circulation of aqueous humor, including growth inhibitory factors, into the equatorial space of the capsule through the holes and grooves in the ring. CLINICAL RELEVANCE: A CAPR may be useful for preventing PCO in the clinical setting.

[Opacification of Hydroview intraocular lenses necessitating lens replacement].

PURPOSE: We report the opacification of Hydroview intraocular lenes necessitating lens replacement. SUBJECTS AND METHODS: This study includes 9 eyes of 7 patients (4 eyes of 3 men and 5 eyes of 4 womens, 52-92 years old) who underwent lens replacement at our hospital. A clinicopathological study and speculation on the incidence of Hydroview opacification were carried over. RESULTS: All patients had hypertension and 3 had diabetes mellitus. Four eyes of 3 cases and 2 eyes of 2 cases demonstrated diabetic retinopathy and pseudoexfoliaton syndrome, respectively. Four of 6 cases, who underwent bilateral lens implantation, showed unilateral opacification. The duration from lens implantation to exchange ranged from 17 to 38 months. Slit-lamp examination revealed generalized opacification with white granular deposits on the lens optic surface, but transparency inside the optic. Three explanted lenses were stained with 1% alizarin red, and were positive for calcium in all cases. The remaining 6 lenses were analyzed with scanning electron microscopy, and showed electrondense granular deposits of 1 to 4 microm diameter. It is theorized that the incidence of Hydroview opacification and necessity of replacement were more than 3.8% and 3.6%, respectively, from the data at one hospital. CONCLUSION: Calcium deposition on Hydroview might occur in more than 3.8% of cases.

Membranous proliferation on the posterior surface of an intraocular lens after Nd:YAG laser capsulotomy.

BACKGROUND: We report on three patients who showed a rare complication, centripetal membranous proliferation from the posterior capsulotomy edge onto the posterior surface of an intraocular lens (IOL), 3 to 6 months after neodymium:YAG (Nd:YAG) capsulotomy. CASES: These three patients had juvenile rheumatoid arthritis, retinitis pigmentosa, and sarcoidosis, respectively, prior to cataract surgery. OBSERVATIONS: Elschnig's pearls developed in the eyes of all three patients after cataract surgery, and were treated by Nd:YAG laser. However, membranous proliferation continued, and Nd:YAG laser treatment was required a second time to disrupt the proliferating fibrous membrane and achieve resolution of the patients' symptoms. CONCLUSIONS: Common factors in our cases and cases in the literature were that the IOLs were biconvex and made of polymethyl methacrylate. Ophthalmologists should be aware that after cataract surgery, lens epithelial cells can proliferate onto any surface that provides adequate protein nourishment.

[Results of surgery on white cataract using trypan blue capsule staining to visualize capsulorrhexis].

PURPOSE: To evaluate surgery on white cataracts using trypan blue capsule staining. METHODS: A retrospective study comprised 64 eyes of 60 patients with white cataract that had surgery with trypan blue capsule staining. The average age was 62.4 years and progress observation periods were 5.6 months. The rate of successful continuous curvilinear capsulorrhexis(CCC), complications, visual acuity, intraocular pressure(IOP), flare value, and corneal endothelial cell loss were studied. RESULTS: The CCC was completed uneventfully in 93.8% eyes. Posterior capsule rupture occurred in 2 eyes, and early perforation in 1 eye. Accidental vitreous staining and endothelial staining with trypan blue were observed in 1 eye each. There were no postoperative complications associated with trypan blue. Forty-five eyes had a best corrected visual acuity of 0.8 or better at the last visit. Twelve eyes had some ocular pathology resulting in visual loss, and a reliable visual acuity test could not be performed in 6 eyes. The mean postoperative IOP was within the normal range. The mean postoperative flare returned to within normal range 1 month after surgery. The mean corneal endothelial loss was 13.7%, and that of eyes with nucleus of grade 2 or softer was only 2.9%. CONCLUSIONS: Cataract surgery using trypan blue was safe and effective in managing white cataracts.

[Vitrectomy for endophthalmitis after cataract surgery].

PURPOSE: To identify risk factors of poor visual outcome with vitrectomy for early-onset endophthalmitis after cataract surgery. PATIENTS AND METHODS: Clinical records of 29 consecutive eyes with endophthalmitis developing within 6 weeks after cataract surgery and that underwent therapeutic vitrectomy between June 1996 and April 2001 were retrospectively reviewed. Twenty-two of the eyes received intravitreal injections of vancomycin and ceftazidime at the time of vitrectomy, and all patients received intravenous antibiotics. Eyes were divided into two groups; group A consisted of 22 eyes with a final visual acuity of 0.2 or greater, and group B consisted of 7 eyes with a final visual acuity of less than 0.2. RESULTS: Fifteen eyes (52%) in group A achieved a visual acuity of 0.5 or better and 8(28%) achieved a visual acuity of 1.0, while 4 eyes in group B developed phthisis bulbi. For eyes with a preoperative visual acuity of hand motions or worse, there was no correlation between final visual acuity and preoperative visual acuity. The overall culture-positive rate was 57%. In group A, methicillin-resistant Staphylococcus epidermidis was identified in 6 eyes, methicillin-resistant Staphylococcus aureus (MRSA) in 3 eyes and enterococcus in 2 eyes. In group B, alpha-hemolytic streptococcus (AHS) was identified in 4 eyes, aspergillus in 1 eye, and MRSA in 1 eye. All isolates were sensitive to vancomycin with the exception of the aspergillus. AHS infection appeared to be associated with wound failure from the initial cataract surgery and a poor visual outcome. Among 3 of the eyes that developed phthisis bulbi, intravitreal injection of antibiotics was not performed. CONCLUSION: Early vitrectomy and intravitreal injection of vancomycin may improve visual outcomes, but infection with AHS may be associated with cataract surgery wound failure and poor visual outcomes.

Inhibition of lens epithelial cell migration at the intraocular lens optic edge: role of capsule bending and contact pressure.

PURPOSE: To evaluate the inhibitory effect of a sharp intraocular lens (IOL) optic edge, a sharp capsule bend, and contact pressure between the optic edge and posterior capsule on lens epithelial cell (LEC) migration. SETTING: Department of Ophthalmology, Kyorin University, Tokyo, Japan. METHODS: This in vitro laboratory study evaluated a tumble-polished convex-plano IOL (CP group), an AcrySof IOL (Alcon) with a sharp edge (AS group), a new IOL with a round ridge (RR group), and a new IOL with a sharp ridge (SR group). The 2 new IOLs have high ridges and high angled loops that create firm contact between the ridge and posterior capsule. After sham cataract surgery, an IOL and a capsular tension ring (CTR) were implanted in the capsular bag of rabbit eyes. The extracted capsular bags containing the CTR and IOL were cultured. The inhibitory effect of each IOL on cell migration was analyzed. Furthermore, LEC migration on the posterior capsule was compared in culture between capsules having a sharp right angle and those with gradually curving bends. RESULTS: The inhibitory effect on cell migration was statistically greatest in the SR group followed by the RR, AS, and CP groups. A sharp capsule bend did not inhibit cell migration. CONCLUSIONS: The results suggest that inhibition of cell migration at the optic edge is regulated by the degree of contact pressure between the optic edge and posterior capsule. A sharp capsule bend might indicate strong contact but does not in itself inhibit cell migration.

Efficacy and safety of the soft-shell technique in cases with a hard lens nucleus.

PURPOSE: To evaluate the efficacy and safety of the soft-shell technique in reducing corneal endothelial cell damage during cataract surgery in patients with a hard lens nucleus. SETTING: Miyata Eye Hospital, Miyakonojo, Miyazaki, Japan. METHODS: Sixty eyes of 57 cataract patients with a hard lens nucleus (Emery-Little classification grade 3 or higher) had phacoemulsification using the soft-shell technique with Healon((R)) (sodium hyaluronate 1%) and Viscoat (sodium hyaluronate 3.0%-chondroitin sulfate 4.0%) (soft-shell group) or with Healon alone (control group). The visual acuity, intraocular pressure (IOP), flare intensity in the anterior chamber, central corneal thickness, and corneal endothelial cell density were evaluated postoperatively. RESULTS: There were no significant IOP elevations in either group. The mean central corneal thickness in the control group was 539 microm +/- 26.0 (SD) preoperatively and 578 +/- 52.0 microm 1 day after surgery; the increase was significant (P =.0154). There was no significant change in the central corneal thickness in the soft-shell group. There were no statistically significant differences between the 2 groups in uncorrected visual acuity, best corrected visual acuity, IOP, flare intensity in the anterior chamber, and central corneal thickness throughout the follow-up. The rate of endothelial cell loss 3 months after surgery was 6.4% +/- 9.6% in the soft-shell group and 16.3% +/- 9.8% in the control group (P =.0003). CONCLUSION: The results suggest that the soft-shell technique is safe and effective in protecting corneal endothelial cells during cataract surgery in patients with a hard lens nucleus.