Long term surgical results and safety profile of the novel CM T Flex scleral fixated intraocular lens.

PURPOSE: To report the long term visual outcomes and complications with use of the novel CM-T Flex scleral fixated intraocular lens (CMT-SFIOL). MATERIALS AND METHODS: 116 eyes that underwent CMT-SFIOL were reviewed and 57 eyes with CMT-SFIOL that completed a 2-year follow-up were included. Main outcome measures noted were best-corrected visual acuity (BCVA) and complications. Postoperatively, follow-ups were done at 1 week (1w), 1 month (1 m), 1 year (1y) and 2-year (2y) intervals. RESULTS: 40 (70.17%) of 57 eyes received CMT-SFIOL for surgical aphakia. Mean follow up was 39.77 ± 8.44 months. BCVA for distance & near improved from 1.26 ± 0.84 to 0.76 ± 0.77, 0.50 ± 0.72 and 0.51 ± 0.73 & 1.28 ± 0.58 to 0.98 ± 0.49, 0.92 ± 0.44 and 0.89 ± 0.40 at 1 m, 1y and 2y respectively (p < 0.001 for all). At 1w, 10 eyes (17.54%) had corneal edema (CE) and 8 eyes (14.03%) had anterior chamber (AC) reaction. Two eyes (3.50%) had IOP > 30 mm Hg and 1 eye (1.75%) had vitreous hemorrhage (VH). At 1 m, 3 eyes (5.26%) had CE and 5 eyes (8.77%) had AC reaction. Two eyes (3.50%) had IOP > 30 mm Hg and 1 eye (1.75%) had VH. Cystoid macular edema was noted in 3 eyes (5.26%). At 1y and 2y, 2 eyes (3.5%) and 1 eye (1.75%), had CE. No decentration, dislocation, haptic exposure or retinal detachment was noted. No eyes required resurgery. CONCLUSION: CM-T Flex SFIOL is an effective method to correct aphakia, with reliable and safe long-term results.

Aphakia treatment with sutureless scleral fixation or retropupillary iris-claw intraocular lens implantation: visual acuity, anterior segment and keratometry outcomes.

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.

Comparison of the effectiveness of different corneal curvature measurement methods for IOL implantation in traumatic aphakic eyes with corneal injury.

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.

Management of Contact Lenses and Visual Development in Pediatric Aphakia.

Congenital cataract is among the main causes of treatable vision loss in childhood. The first weeks and months of life are a critical time for the development of vision. Therefore, early cataract surgery and effective multifaceted treatment of the resulting aphakia in the early stages of life are of great value for the management of vision development. Among the treatment models, contact lenses (CL) have an important place in infancy and early childhood up to the age of 2 years. Although good visual gains were not considered very likely, especially in unilateral aphakia, important steps have been taken in the treatment of pediatric aphakia thanks to the surgical techniques developed over time and the increasing experience with optical correction systems, especially CLs. This review examines current developments in the types of CL used in pediatric aphakia, their application features, comparison with other optical systems, the features of amblyopia treatment in the presence of CL, and the results obtained with family compliance to CL wear and occlusion therapy in the light of existing studies.

Flange depth for scleral pocket vs no pocket techniques for intrascleral intraocular lens fixation.

PURPOSE: To compare flange depth for a modified scleral pocket (SP) vs no scleral pocket (NSP) technique (Yamane technique) for intrascleral intraocular lens (IOL) fixation. SETTING: Instituto de Oftalmología Santa Fe, Santa Fe, Argentina. DESIGN: Prospective, randomized, single-surgeon, observational study. METHODS: Eyes with aphakia and no capsular support were included. They were divided into 2 groups: one was programmed for a double-needle flanged intrascleral IOL fixation as originally described by Shin Yamane with NSP and the second group had a modified SP technique. Flange depth was measured with anterior-segment optical coherence tomography (AS-OCT) at 1 month, 3 months, 6 months, and 12 months postoperatively, and the results were compared. RESULTS: Each group comprised 18 eyes of 18 patients, giving a total of 36 flanges per group. The groups were comparable preoperatively. At 12 months, uncorrected distance visual acuity and corrected distance visual acuity (CDVA) were not statistically different for both groups (P = .333; P = .448). Spherical equivalent (SEQ) was not significantly different between groups at 12 months postoperatively (P = .078). AS-OCT revealed a significantly deeper flange position for the SP group at 1 month, 3 months, 6 months, and 12 months postoperatively (P < .05). CONCLUSIONS: When performing a double-needle intrascleral IOL fixation in aphakic eyes with no capsular support, a modified scleral pocket technique provides a significantly deeper flange position with no difference in CDVA or SEQ 12 months postoperatively.

Contact lenses in paediatric aphakia in the Netherlands; A multicentre retrospective chart study.

PURPOSE: The main aim of this study was to evaluate the type, parameters, loss and complications of contact lenses (CLs) in the treatment of paediatric aphakia over a 10-year period. METHODS: This retrospective multicentre chart review included the files of aphakic CL wearers under the age of 9 years old that were treated between 2008 and 2018. Patients with traumatic aphakia and scarring of the cornea were excluded. The following data were collected; demographic data, cataract type (congenital or secondary), CL type, parameters and wearing time, reason for replacement and discontinuation of the CLs, visual acuity (VA), prophylactic use of antibiotics (ABs), and complications. RESULTS: Ninety-one aphakic children (132 eyes) were fitted with soft CLs. The median age of cataract extraction was 10.50 weeks (interquartile range (IQR) 7,15) in the congenital cataract group and 112 weeks (IQR 41,285) in the secondary cataract group. At the initial fitting a silicone elastomer CL was fitted in 86 % and a silicone hydrogel CL in 12 %, the remaining 2 % were mixed CL types. The median CL power at baseline was + 29 D (IQR 25,32) and after 3 years of wear the median power had shifted significantly to + 20 D (IQR 17,26), P < 0.001. A total of 1083 extra CL replacements were needed of which 414 in the first year of wear. Of these 414 replacements almost half (46 %;n = 191) were due to loss of the CL. Complications developed in 8 (9 %) cases and 7 (8 %) patients discontinued CL wear. CONCLUSION: This paper confirms that paediatric aphakia can be successfully treated with soft CLs with low rates of complications and discontinuation encountered. Unscheduled CL replacements due to loss are a concern, especially in the first year, and are straining for both the care giver and medical system. Attentive care and clear information is advised during the first year of CL wear.

Patching in Children With Unilateral Congenital Cataract and Child Functioning and Parenting Stress.

Importance: Parents may be concerned about the adverse outcomes of occlusion therapy in children treated for unilateral congenital cataract (UCC). Objective: To determine whether occlusion therapy in children treated for UCC with poor visual outcomes is negatively associated with poorer child and/or family functioning. Design, Setting, and Participants: This cohort study was conducted in 2023 using data collected between 2006 and 2016 in the Infant Aphakia Treatment Study (IATS). IATS participants with a visual acuity (VA) of 20/200 or worse were included. Statistical analysis was performed from July 2022 to October 2023. Exposure: Caregivers reported the mean daily minutes of patching during the 12 months prior to the VA assessment at 4.5 years of age. Patching was categorized as minimal (<15 minutes per day), moderate (15 to <120 minutes per day), or extensive (≥120 minutes per day). Main Outcome Measures: At 4.25 and 10.5 years of age, caregivers reported stress associated with the parenting role using the Parenting Stress Index and the Ocular Treatment Index and child behavior problems using the Achenbach Child Behavior Checklist. Motor skills were assessed at age 54 months using the Movement Assessment Battery for Children-Second Edition. Children completed the Harter Self-Perception Profile for Children at age 10.5 years. One-way analysis of variance and χ2 tests were used to compare outcomes by amount of patching. Results: Patching data were available for 47 of 53 children (88.7%) with a VA of 20/200 or worse. Among these 47 children with patching data included in the study, 20 (42.5%) were female, 27 (57.5%) were male, 12 (25.5%) were reported to have been patched fewer than 15 minutes per day, 11 (23.4%) were patched 16 to 119 minutes per day, and 24 (51.1%) were patched at least 120 minutes per day. Parenting stress, child behavior problems, motor functioning, and child self-perception were similar in all groups. For example, after adjusting for gender and insurance status, there was a nonsignificant difference between mean stress scores of 11.0 (95% CI, -4.5 to 26.5) points for parents who reported minimal patching vs parents who reported patching at least 120 minutes per day, and there was no significant difference in children's report of their global self-worth (0.0 [95% CI, -0.4 to 0.3] points). Conclusions and Relevance: Occlusion therapy was not negatively associated with family or child functioning. Although the sample size was limited, these results do not support changes to the current practice guidelines.

Fusion-Flanged Intrascleral Intraocular Lens Fixation Technique: Simple, Safe, Efficient.

PURPOSE: To develop a new, sutureless intrascleral intraocular lens (IOL) fixation technique based on the Yamane double-needle and Canabrava 4-flanged techniques. METHODS: The Fusion-Flanged technique involves using a 7-0 polypropylene suture loop threaded through the eyelets of the IOL. Afterward, both ends of the suture are passed outside the eye through a 27-gauge needle. This technique creates a single flange by joining the 2 suture ends through handheld cautery, and this flange is then embedded into the scleral tunnel to securely fix the IOL in place. RESULTS: This technique was performed on a total of 7 aphakic patients. Four of them had encountered complications following manual small incision cataract surgery, while the remaining 3 experienced complications after phacoemulsification. The results indicated a significant improvement in visual acuity, with mean preoperative and postoperative corrected distance visual acuities of 0.77 ± 0.11 and 0.27 ± 0.08 (logarithm of the minimum angle of resolution [logMAR] units), respectively. CONCLUSIONS: The Fusion-Flanged intrascleral IOL fixation technique offers improvements in simplicity, safety, and the overall efficiency when compared to existing sutureless intrascleral fixation techniques. Notably, this technique is versatile and can be applied to both non-foldable and foldable IOLs.

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.

The comparison of corneal densitometry in cases with glaucoma following childhood cataract surgery and juvenile glaucoma.

PURPOSE: To compare the corneal densitometry (CD) in pediatric cases with glaucoma following childhood cataract surgery and juvenile open-angle glaucoma (JOAG). METHODS: This prospective comparative study involved 13 eyes with JOAG, 12 eyes with pseudophakic glaucoma, 13 eyes with aphakic glaucoma, and 15 control subjects. Pentacam HR Scheimpflug corneal topography was employed to evaluate corneal thickness (CCT) and CD values. RESULTS: The mean intraocular pressure (IOP) and CCT were significantly higher in aphakic glaucoma cases than the other groups (p = 0.001). In aphakic eyes, the mean CD values were higher in most of the anterior, center, and posterior layers of 0-2 mm, 2-6 mm, 6-10 mm, and total zones (p < 0.001 for all). In pseudophakic eyes, the mean CD values were statistically similar with that of aphakic eyes and higher than that of JOAG and control eyes in all layers of 0-2 mm zone and in anterior layer of 10-12 mm and anterior and total layers of 2-6 mm zones (p < 0.05 for all). The CD values demonstrated significant correlations with CCT values in both aphakic and pseudophakic eyes. However, a significant correlation of CD values with IOP was only demonstrated in aphakic eyes (p = 0.01 for all). CONCLUSION: The probable effects of childhood cataract surgery especially aphakia might cause corneal backscatter of light and increased CD in all layers in all zones of the cornea. Increased CD values and its correlation with CCT and IOP in aphakic glaucoma eyes may be of importance in clinical management.

Intraocular lens tilt and decentration in secondary ciliary sulcus implantation in paediatric eyes: A 3-year prospective study.

PURPOSE: The purpose of this study was to compare the tilt and decentration of one-piece anti-vaulting haptic intraocular lenses (IOL) and three-piece C-loop haptic IOLs in paediatric eyes undergoing secondary IOL implantation into the ciliary sulcus. METHODS: Paediatric aphakic patients receiving either one-piece anti-vaulting haptic or three-piece C-loop haptic IOL implants into the ciliary sulcus were enrolled in this prospective non-randomized interventional study and followed up for 3 years. IOL decentration and tilt were measured using Scheimpflug images. Preoperative and postoperative information, including demographic data and ocular biometric parameters and complications, were collected and analysed. RESULTS: Among 123 eyes of 79 paediatric patients, there were 72 eyes (58.54%) in the anti-vaulting haptic IOL group and 51 eyes (41.46%) in the C-loop haptic group. The anti-vaulting haptic IOL group had a lower incidence of clinically significant vertical IOL decentration than the C-loop haptic IOL group (23.88% vs. 43.14%, p = 0.037). No intergroup differences were observed in vertical or horizontal tilt or in horizontal decentration (all p > 0.05). One-piece anti-vaulting haptic IOL implantation was associated with a lower risk of clinically significant vertical decentration than three-piece C-loop haptic IOL implantation (odds ratio: 0.42, p = 0.037). There was a higher incidence of IOL dislocation in the C-loop haptic IOL group (15.22% vs. 4.17%, p = 0.046). CONCLUSIONS: In paediatric aphakic eyes undergoing secondary IOL implantation into the ciliary sulcus, one-piece anti-vaulting haptic IOLs can reduce the risk of clinically significant vertical IOL decentration compared with three-piece C-loop haptic IOLs and may favour long-term IOL positional stability.

Reopening the capsular bag by removing the capsular proliferative membrane to enable secondary in-the-bag intraocular lens implantation in pediatric aphakic eyes.

PURPOSE: To present a surgical technique for reopening the capsular bag in pediatric aphakia. SETTING: Zhongshan Ophthalmic Center, Guangzhou, China. DESIGN: Case series study. METHODS: Consecutive pediatric patients with bilateral aphakia requiring secondary intraocular lens (IOL) implantation between July 2021 and June 2022 were included. The diameter of the capsular proliferative membranous ring (PMR) and position of IOL implantation were documented. Various parameters of capsular bag opening during primary cataract removal and secondary surgery were also analyzed. RESULTS: 48 eyes were included with a mean follow-up of 8.1 ± 4.4 months. Using the surgical technique developed in this study, the capsular bag was successfully reopened with in-the-bag (ITB) implantation in 43 eyes (89.6%). ITB implantation was accomplished in all eyes with an outer diameter of PMR ≤5.5 mm and in 3 of 8 eyes (37.5%) with an outer diameter of PMR >5.5 mm. A positive correlation was observed between the primary and secondary anterior capsular opening diameters (ACODs) ( r = 0.422, P = .007) and the primary and secondary posterior capsular opening diameters (PCODs) ( r = 0.619, P < .001). The inner diameter of PMR was found to be positively correlated with secondary PCOD ( r = 0.728, P < .001) and the outer diameter with secondary ACOD ( r = 0.669, P < .001). CONCLUSIONS: This was a safe and effective surgical technique for pediatric secondary IOL implantation with maximum preservation of the peripheral capsule. Aphakic eyes with an outer diameter of PMR ≤5.5 mm are preferred for secondary ITB implantation.

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.

Managing Pediatric Cataract Patients - The Whole Story: Aphakic Contact Lenses in Children - Techniques and Challenges.

Infantile cataract is one of the major causes of visual impairment in children. This article will discuss some of the techniques, challenges, complications, and compliance issues with aphakic contact lenses.

Role of Intraocular Lens Implantation in Children.

PURPOSE: To summarize recent literature and provide an update on the role of intraocular lens implantation in children. DESIGN: AOC/AACO/AAO 2022 Symposium Summary. INTERVENTION: None. RESULTS: Literature review surrounding the use of intraocular lenses in children. Attention was given to multicenter study efforts including the Infant Aphakia Treatment Study, the Toddler Aphakia and Pseudophakia Study, and the Pediatric Eye Disease Investigator Group Cataract Registry. CONCLUSIONS: Intraocular lenses are a valuable tool in the care of children with lens abnormalities. Recent studies and advancements in fixation techniques have complimented our care and highlighted age and ocular dependent risks. Thorough initial clinical assessment and long-term postoperative management are critical in maximizing outcomes.

What we have learned from the Infant Aphakia Treatment Study: The 49th Annual Frank D. Costenbader Lecture.

Unilateral congenital cataracts lead to deprivation amblyopia, which can be severe. Until the 1970s, they were believed to be always associated with poor visual outcomes. However, advances in our understanding of the plasticity of the infant brain and the development of better surgical techniques allowed good visual outcomes to be obtained in a few of these patients. The Infant Aphakia Treatment Study (IATS) was conducted to provide empirical evidence regarding the best type of optical correction to be used following surgical extraction of the cataract. Specifically, infants were randomly assigned to either be left aphakic and to wear contact lenses or an intraocular lens (IOL) was implanted and the residual refractive error was corrected with spectacles. The study found that good visual acuity and stereopsis could be achieved in some patients in both treatment groups. Early cataract surgery, consistent optical correction and part-time patching of the fellow eye are important elements needed to achieve good visual outcomes. However, excess patching of the fellow eye may interfere with the development of stereopsis. More adverse events occurred after IOL implantation, particularly visual axis opacification, compared with the infants who were left aphakic. Glaucoma-related adverse events occurred in 40% of eyes after a 10-year follow-up and were not associated with IOL implantation. Further research is needed to increase the percentage of children with unilateral congenital cataracts who achieve good visual outcomes.

Visual outcomes and safety profile of intraocular lens implantation versus aphakia in children with microspherophakia with no subluxation.

OBJECTIVE: To study the visual, refractive and surgical outcomes of intraocular lens (IOL) implantation versus aphakia in children with microspherophakia. DESIGN: Retrospective, comparative, non-randomised interventional study. METHODS: All consecutive children with microspherophakia who satisfied the inclusion criteria were included. The eyes that underwent in-the-bag IOL implantation and those that were left aphakic were included in groups A and B, respectively. The postoperative visual outcomes, IOL stability and complications during the follow-up period were studied. RESULTS: 22 eyes (13 patients, male 76%), of which 12 eyes were in group A and 10 eyes in group B. The mean±SE of age at surgery was 9.4±1.4 and 7.3±0.9 years in group A and group B, respectively (p value 0.18). The mean follow-up of group A was 0.9±0.4 years (median 0.5 years; Q1 0.04, Q3 2.16) and group B was 1.3±0.9 years (median 0.147 years; Q1 0.08, Q3 0.39) (p value 0.76). All the baseline biometric variables including best-corrected visual acuity (BCVA) were comparable in each group. The final BCVA in logMAR adjusted for follow-up was comparable in both group A (0.29±0.06) and group B (0.52±0.09) (p value 0.06). Mean predictive error of IOL power in microspherophakia was 0.17±0.43.The most common complication in group A was visual axis opacification of two eyes (16.7%, 95% CI 2.9% to 49.1%), of which one eye (8.3%, 95% CI 0.4% to 40.2%) needed membranectomy. Vitreous in anterior chamber was the most common complication in group B, seen in two eyes (20%, 95% CI 3.5% to 55.8%), of which one eye (10%, 95% CI 0.5% to 45.9%) underwent YAG laser vitreolysis. The survival analysis (p value 0.18) was comparable in each group. CONCLUSION: In-the-bag IOL is an option, which can be considered in selected cases of microspherophakia in developing nations where regular follow-up and economic constraints are a major concern.

Soft contact lens options in the management of pediatric aphakia - A quantitative and qualitative assessment.

BACKGROUND: The main contact lens for pediatric aphakia has historically been a silicone elastomer lens (Silsoft SuperPlus). Due to supply chain disruption, many aphakic children required an alternative lens. We performed quantitative and qualitative comparisons between Silsoft SuperPlus and alternative aphakic soft contacts. METHOD: Sixty-nine aphakic eyes of 49 patients wearing Silsoft SuperPlus lenses underwent the refitting process into an alternative soft contact. Data collected included lens parameters, visual acuity, keratometry, horizontal visible iris diameter, and over-refraction. A 6-question survey assessing the patients'/guardians' experience with Silsoft SuperPlus versus the alternative lens was conducted at initial fit and 1-3 months post-fit. RESULTS: Twenty-four patients (49 %), 4(8 %), and 1(2 %) were refit into Flexlens Definitive 74, Biofinity XR, and Intelliwave Pro Toric lenses, respectively. Sixteen patients (34 %) remained in Silsoft SuperPlus due to personal lens surplus or inability to handle the new lens while 2(4 %) opted for glasses. Silsoft SuperPlus was typically successful in eyes with average keratometry (AveK) 7.4-7.6 mm. Flexlens Definitive 74 required a base curve 0.4 mm steeper than the AveK. Patients'/guardias' reported a trend toward greater comfort with handling Silsoft SuperPlus, however, patients experienced less adverse side effects with the alternative soft contact lenses. CONCLUSIONS: Flexlens Definitive 74 was an adequate alternative to Silsoft SuperPlus in aphakic children, however lens parameters must be steepened. Keratometry streamlined the contact lens fitting process. Alternative soft lenses are a cost-effective alternative to Silsoft contact lenses.

Safety and efficacy in pediatric secondary intraocular lens implantation, in-the-bag versus sulcus implantation: a multicenter, single-blinded randomized controlled trial.

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 χ2 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.

Incidence of Glaucoma-Related Adverse Events in the First 5 Years After Pediatric Lensectomy.

Importance: Glaucoma can develop following cataract removal in children. Objective: To assess the cumulative incidence of glaucoma-related adverse events (defined as glaucoma or glaucoma suspect) and factors associated with risk of these adverse events in the first 5 years after lensectomy prior to 13 years of age. Design, Setting, and Participants: This cohort study used longitudinal registry data collected at enrollment and annually for 5 years from 45 institutional and 16 community sites. Participants were children aged 12 years or younger with at least 1 office visit after lensectomy from June 2012 to July 2015. Data were analyzed from February through December 2022. Exposures: Usual clinical care after lensectomy. Main Outcomes and Measures: The main outcomes were cumulative incidence of glaucoma-related adverse events and baseline factors associated with risk of these adverse events. Results: The study included 810 children (1049 eyes); 443 eyes of 321 children (55% female; mean [SD] age, 0.89 [1.97] years) were aphakic after lensectomy, and 606 eyes of 489 children (53% male; mean [SD] age, 5.65 [3.32] years) were pseudophakic. The 5-year cumulative incidence of glaucoma-related adverse events was 29% (95% CI, 25%-34%) in 443 eyes with aphakia and 7% (95% CI, 5%-9%) in 606 eyes with pseudophakia; 7% (95% CI, 5%-10%) of aphakic eyes and 3% (95% CI, 2%-5%) of pseudophakic eyes were diagnosed as glaucoma suspect. Among aphakic eyes, a higher risk for glaucoma-related adverse events was associated with 4 of 8 factors, including age less than 3 months (vs ≥3 months: adjusted hazard ratio [aHR], 2.88; 99% CI, 1.57-5.23), abnormal anterior segment (vs normal: aHR, 2.88; 99% CI, 1.56-5.30), intraoperative complications at time of lensectomy (vs none; aHR, 2.25; 99% CI, 1.04-4.87), and bilaterality (vs unilaterality: aHR, 1.88; 99% CI, 1.02-3.48). Neither of the 2 factors evaluated for pseudophakic eyes, laterality and anterior vitrectomy, were associated with risk of glaucoma-related adverse events. Conclusions and Relevance: In this cohort study, glaucoma-related adverse events were common after cataract surgery in children; age less than 3 months at surgery was associated with elevated risk of the adverse events in aphakic eyes. Children with pseudophakia, who were older at surgery, less frequently developed a glaucoma-related adverse event within 5 years of lensectomy. The findings suggest that ongoing monitoring for the development of glaucoma is needed after lensectomy at any age.