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Parts of material previously presented at Annual Meetings of the Association for Research in Vision and Ophthalmology and the American Association of Pediatric Ophthalmology and Strabismus. Trial Registration: ClinicalTrials.gov Identifier: NCT00212134.

Purpose Evaluation of anterior segment parameters using the Scheimpflug corneal topography 1 year after surgery in patients who underwent sutureless scleral fixation intraocular lens (SFIOL) implantation using the modified Yamane technique and retropupillary iris-claw intraocular lens (RPIOL) implantation. Methods A total of 60 eyes from 57 patients who underwent sutureless SFIOL implantation and 57 eyes from 52 patients who underwent RPIOL implantation were included. Anterior chamber depth (ACD), anterior chamber angle (ACA), anterior chamber volume (ACV), anterior–posterior corneal astigmatism, and keratometric values were assessed using the Scheimpflug corneal topography (Pentacam HR, Germany). Results There was no statistically significant difference in postoperative UCVA and BCVA between the sutureless SFIOL and the RPIOL group ( p  = 0.236, p  = 0.293, respectively). While there was no statistically significant difference in postoperative IOP between the two groups ( p  = 0.223), a statistically significant decrease in IOP was observed in both groups ( p  < 0.001). While there was no statistical difference between the sutureless SFIOL group and the RPIOL group in terms of spherical value ( p  = 0.441) and spherical equivalence ( p  = 0.237), there was a statistically significant difference in cylindrical value ( p  < 0.001). While there was a statistical difference in anterior astigmatism ( p  < 0.001), there was no statistical difference in posterior astigmatism ( p  = 0.405). There was no statistical difference in terms of ACV, ACD, and ACA between the sutureless SFIOL and the RPIOL group ( p  = 0.812, p  = 0.770, p  = 0.401, respectively). Conclusion In this study, although there was a statistical difference in cylindrical value and anterior corneal astigmatism between the sutureless SFIOL and RPIOL groups, vision was not affected. According to this study, sutureless SFIOL and RPIOL are two successful methods in terms of visual acuity, anterior segment, and keratometry outcomes in aphakic patients after phacoemulsification.

Background Treatment of pediatric cataract remains challenging because of the extremely high incidence of postoperative adverse events (AEs), especially the AEs related to the locations of secondary implanted intraocular lens (IOL). There are two common locations for secondary IOL implantation in pediatric aphakic eyes: ciliary sulcus or in-the-bag implantation. However, there are currently no large, prospective studies comparing complication rates and visual prognosis of in-the-bag versus ciliarysulcus secondary IOL implantation in pediatric patients. Whether or how much secondary in-the-bag IOL implantation benefits the pediatric patients more than sulcus implantation and deserves to be performed routinely by surgeons remains to be elucidated. Here, we describe the protocol of a randomized controlled trial (RCT) designed to evaluate the safety and efficacy of two approaches of IOL implantation in pediatric aphakia. Methods The study is a multicenter, single-blinded RCT with 10 years of follow-up. Overall, a minimum of 286 eyes (approximately 228 participants assuming 75% have two study eyes) will be recruited. This study will be carried out in four eye clinics across China. Consecutive eligible patients are randomized to undergo either secondary in-the-bag IOL implantation or secondary sulcus IOL implantation. Participants with two eyes eligible will receive the same treatment. The primary outcomes are IOL decentration and the incidence of glaucoma-related AEs. The secondary outcomes include the incidence of other AEs, IOL tilt, visual acuity, and ocular refractive power. Analysis of the primary and secondary outcomes is to be based on the intention-to-treat and per-protocol analysis. Statistical analyses will include the χ 2 test or Fisher’s exact test for the primary outcome, mixed model and generalized estimated equation (GEE) model for the secondary outcome, Kaplan–Meier survival curves for the cumulative probability of glaucoma-related AEs over time in each group. Discussion To the best of our knowledge, this study is the first RCT to evaluate the safety and efficacy of secondary IOL implantation in pediatric aphakia. The results will provide high-quality evidence for the clinical guidelines for the treatment of pediatric aphakia. Trial registration ClinicalTrials.gov NCT05136950. Registered on 1 November 2021.

Purpose: To compare the outcomes of anterior chamber and retropupillary implantation of iris-claw Artisan intraocular lenses (IOL). Design: Prospective, randomized, single-blinded study. Patients and Methods: Forty eyes of forty aphakic patients were enrolled. Patients were randomized into two groups. Each group includes twenty patients. Group 1 received anterior chamber Artisan IOL implantation. Group 2 received retropupillary Artisan IOL implantation. Preoperative and postoperative corrected distance visual acuity (CDVA), intraocular pressure (IOP), and all complications were noted and compared at 6 months follow-up. Results: Each two groups obtained a significant improvement in CDVA (P < 0.05). Four patients in Group 1 and five patients in Group 2 had significant but nonpermanent increase at IOP values. There were one and two pupillary irregularity in Group 1 and Group 2, respectively. In one patient, a shallow and inferior located retinal detachment were encountered in anterior chamber group. Conclusions: The results were not significantly different between the two fixation techniques for iris-claw lens. The surgery procedure is dependent to surgeon experience and eye's conditions.

Background/Aim To assess the refractive outcomes of secondary intraocular lenses (IOL) in patients with traumatic aphakic eyes with corneal penetrating injury and compare different corneal curvature measurement methods. Methods Patients with unilateral penetrating eye injuries underwent corneal wound repair and cataract extraction, followed by secondary IOL implantation. Corneal curvature measurements were taken on the contralateral healthy eye (Group A), from the affected eye before removing corneal sutures (Group B), or after suture removal (Group C). The refractive outcomes were compared among the three groups. Results The study included 261 eyes. The Mean Absolute Error (MAE) in Group C (0.99 ± 0.85 D) was significantly smaller than that in Group A (1.87 ± 1.71 D) and Group B (1.37 ± 1.20 D) (both P  < 0.001). Moreover, the percentage of eyes with IOL prediction errors within ± 0.50 D in Group C (40%) was higher than that in group A (21.7%) (OR = 2.364, 95%CI: 1.272–4.392, P  = 0.006) and group B (28.0%) (OR = 1.714, 95%CI: 0.948–3.099, P  = 0.073), and the percentage of eyes with IOL prediction errors within ± 1.0 D in Group C (90.9%) was higher than that in group A (67.9%) (OR = 4.758, 95%CI: 2.131–10.626, P  < 0.001) and group B (75.0%) (OR = 3.370, 95%CI: 1.483–7.660, P  = 0.003) as well. Conclusions In traumatic aphakic eyes with corneal sutures, IOL power calculation based on the corneal curvature of the injured eye after removing the corneal sutures yields the best refractive outcomes.

Though several procedures of IOL implantation have been described (sutured scleral fixation, intra-scleral fixation, angle-supported anterior chamber, and anterior chamber or retropupillary iris-claw IOLs), there are no randomized trials which are comparing different techniques. Hence, the surgical treatment of aphakia still remains controversial and challenging. The purpose of this study was to compare the long-term efficacy and the rate of complications of anterior versus posterior Iris-claw intraocular lenses (IOL) implantation to correct for the treatment of aphakia without sufficient capsule support. Consecutive eyes having secondary implantation of aphakic iris-fixated IOLs with a follow-up of at least 5 years were considered. Mean correct distance visual acuity (CDVA) changes, percentage of eyes with CDVA improvement, mean corneal endothelial cell density (CECD) loss and the rate of other complications were used for statistical analysis. The study evaluated a total of 180 eyes (Group A: 87 anterior chamber iris-claw fixation, Group B: 93 retropupillary iris-claw implantation) of 180 consecutive different patients, with aphakia of various reasons. CDVA improved significantly in both groups after surgery (P<0.001, ANOVA), and was remarkably higher than baseline in both groups from first week and during the entire follow-up (P<0.001, Tukey's Honest Significant Difference). There was no statistically significant difference in CDVA between the two groups during each follow-up visits (P = NS, unpaired t-test) and in the CDVA improvement percentage between the two groups (P = 0.882, Chi-square test). No significant changes in CECD were noted after surgery in both groups (ANOVA Group A: P = 0.067, Group B: P = 0.330P). No intra-operative complications occurred in both groups. There was no statistically significant difference in the rate of complications between the two groups (P = NS, Chi-square test), except for pigment precipitates which were higher in Group A (P<0.05, Chi-square test). Five-year follow-up shows that secondary implantation of aphakic IOLs is effective and safe for the correction treatment of aphakia in eyes without capsule support.

Purpose: To evaluate outcomes of anterior chamber intraocular lens (ACIOL) implantation with vitrectomy in eyes with surgical or traumatic aphakia, and subluxated or dislocated lens. Methods: In this retrospective study, we evaluated patients who underwent pars plans vitrectomy with ACIOL implantation from April 2016 to March 2019. Patients with minimum follow-up period of 1 year and operated by single surgeon were included. Ophthalmic history, indication for surgery, BCVA, IOP, slit-lamp examination, and fundus assessment findings were noted. Postoperatively best-corrected visual acuity (BCVA), intraocular pressure (IOP) and complications if any were noted. Results: Ninety eyes of 88 patients were included in the study. The mean age of the patients was 60.2 ± 10.2 yrs. Majority (75.6%) were males and 24.4% were females. Indications for pars-plana vitrectomy (PPV) with ACIOL implantation were nucleus drop in 16.6%, IOL drop in 25.5%, large posterior capsular rupture (PCR) with vitreous disturbance or zonular dehiscence (ZD) during cataract surgery in 33.3%, more than 180° subluxation of lens in 10% and traumatic lens or intraocular lens (IOL) drop in 14.4% cases. Preoperative and postoperative mean Log MAR visual acuity was 1.59 ± 0.44 and 0.36 ± 0.33 respectively, with few complications like cystoid macular edema (CME) in 8.8%, persistently raised IOP in 4.4%, persistent uveitis in 2.2%, retinal detachment (RD) in 2.2%, and tilted IOL in 1.1% cases. Conclusion: Out of different options available for secondary IOL implantation in patients with poor capsular support ACIOL has the advantages of cost-effectiveness, small learning curve, faster surgical time with a lesser rate of complications like IOL tilt, vitreous hemorrhage, and suture erosion as compared to scleral-fixated IOL (SF-IOL). Comparable visual outcome can be obtained by proper patient selection in these cases.

Purpose: To describe the clinical spectrum and management of glaucoma in congenital aphakia. Methods: The demographics and clinical spectrum of eyes with congenital aphakia with and without glaucoma were compared, and management outcomes of congenital aphakia cases with glaucoma were studied retrospectively between April 2000 and June 2020. Results: There were a total of 168 eyes (84 subjects) with a diagnosis of congenital aphakia, of which 29 eyes of 18 subjects were diagnosed with glaucoma. Corneal opacity was the presenting complaint in 26/29 eyes with glaucoma and 139/139 eyes without glaucoma. The (interquartile range (IQR)) horizontal corneal diameter was 10.5mm (IQR, 9.0-12.5) and 8mm (IQR, 5-10) in eyes with and without glaucoma (P = 0.01), respectively. The median (IQR) axial length was 17.5mm (IQR, 13.5-19.5) and 15mm (IQR, 14-16) mm in eyes with and without glaucoma (P = 0.03), respectively. Nineteen eyes with glaucoma had adequate intraocular pressure (IOP) control with one medication. Three eyes underwent transscleral diode cyclophotocoagulation and maintained IOP without medications. Three eyes underwent trabeculectomy and trabeculotomy, trabeculectomy followed by penetrating keratoplasty, and trabeculectomy, respectively, of which two eyes became phthisical. At the last follow-up, the median (IQR) IOP was 14 mm Hg (IQR, 14-17) Hg. The median (IQR) follow-up duration was 4.53 months (IQR, 2.03- 48.06). Conclusion: One-fifth of the eyes with congenital aphakia had secondary developmental glaucoma. The corneal diameter and axial lengths were higher in the eyes with glaucoma compared to eyes without glaucoma. Medical management is the preferred short-term mode of IOP control. Transscleral cyclophotocoagulation may be preferred over surgical intervention.

Purpose To identify factors associated with stereopsis in children with good visual acuity after unilateral congenital cataract surgery in the Infant Aphakia Treatment Study. Patients and methods Infants with a unilateral congenital cataract ( n =114) were randomized to IOL implantation or contact lens correction after cataract surgery. At age 4.5 years, a masked examiner assessed HOTV acuity and stereopsis. Adherence to patching was assessed using 48-h recall telephone interviews and 7-day diaries throughout the first 5 years of life. Ocular motility was evaluated at age 5 years. Baseline, postoperative, and adherence findings were compared between patients with 20/40 or better acuity in their treated eyes with or without stereopsis. Results Thirty (27%) of 112 patients who were evaluated at age 4.5 years had 20/40 or better acuity in their treated eye. Stereopsis was present on one or more tests in 15 of these 30 (50%) children. Baseline characteristics and postoperative findings did not differ between patients with or without stereopsis. Children with stereopsis were more likely to be orthotropic at distance ( P =0.003) and were patched for fewer hours per day throughout the first 5 years of life and the difference increased over time ( P <0.001). On average children with stereopsis were patched for 3.4 h/day during the first year of life and patching steadily decreased to 1.8 h/day by age 4 years. Conclusion Among children with good vision following unilateral congenital cataract surgery, orthophoria and fewer hours of patching, particularly during years 2, 3, and 4, are associated with some evidence of stereopsis.

Purpose To evaluate safety and efficacy of difluprednate 0.05% ophthalmic emulsion for treatment of postoperative inflammation after cataract surgery in pediatric patients. Methods This was a phase 3B, multicentre, randomized, double-masked, active-controlled study of patients aged 0–3 years who underwent uncomplicated cataract surgery in one eye, with/without intraocular lens implantation. Patients were randomized to receive difluprednate 0.05% four times daily or prednisolone acetate 1% for 14 days post surgery, followed by tapering for 14 days. Safety included evaluation of adverse events. Primary efficacy was the proportion of patients with an anterior cell grade of 0 (no cells) at day 14; secondary efficacy was a global inflammation score. Results Forty patients were randomized to each treatment group. Adverse drug reactions included corneal oedema (difluprednate 0.5%, n =1; prednisolone acetate 1%, n =0) and increased intraocular pressure or ocular hypertension ( n =2/group). Mean intraocular pressure values during treatment were 2–3 mm Hg higher with difluprednate 0.05% compared with prednisolone acetate 1%; mean values were similar between groups by the first week after treatment cessation. At 2 weeks post surgery, the incidence of complete clearing of anterior chamber cells was similar between groups (difluprednate 0.05%, n =30 (78.9%); prednisolone acetate 1%, n =31 (77.5%). Compared with prednisolone acetate 1%, approximately twice as many difluprednate 0.05%-treated patients had a global inflammation assessment score indicating no inflammation on day 1 ( n =12 (30.8%) vs n =7 (17.5%) and day 8 ( n =18 (48.7%) vs n =10 (25.0%). Conclusions Difluprednate 0.05% four times daily showed safety and efficacy profiles similar to prednisolone acetate 1% four times daily in children 0–3 years undergoing cataract surgery.