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Complications in the first 5 years following cataract surgery in infants with and without intraocular lens implantation in the Infant Aphakia Treatment Study.

ABSTRACT: To compare rates and severity of complications between infants undergoing cataract surgery with and without intraocular lens (IOL) implantation.Prospective randomized clinical trial.A total of 114 infants were enrolled in the Infant Aphakia Treatment Study, a randomized, multi-center (12) clinical trial comparing the treatment of unilateral aphakia in patients under 7 months of age with a primary IOL implant or contact lens. The rate, character, and severity of intraoperative complications, adverse events, and additional intraocular surgeries during the first 5 postoperative years in the 2 groups were examined.There were more patients with intraoperative complications (28% vs 11%, P = .031), adverse events (81% vs 56%, P = .008), and more additional intraocular surgeries (72% vs 16%, P < .0001) in the IOL group than in the contact lens group. However, the number of patients with adverse events in the contact lens group increased (15 to 24) in postoperative years 2-5 compared to the first postoperative year, while it decreased (44 to 14) in years 2-5 compared to the first postoperative year in the IOL group. If only one half of the patients in the contact lens (aphakic) group eventually undergo secondary IOL implantation, the number of additional intraocular surgeries in the 2 groups will be approximately equal.The increased rate of complications, adverse events, and additional intraocular surgeries associated with IOL implantation in infants <7 months of age militates toward leaving babies aphakic if it is considered likely that the family will be successful with contact lens correction.

SUBMITTER: Plager DA

PROVIDER: S-EPMC4547784 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature

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Myopic Shift 5 Years after Intraocular Lens Implantation in the Infant Aphakia Treatment Study.

Project description:PurposeTo report the myopic shift at 5 years of age after cataract surgery with intraocular lens (IOL) implantation for infants enrolled in the Infant Aphakia Treatment Study (IATS).MethodsRefractions were performed at 1 month and every 3 months postoperatively until age 4 years and then at ages 4.25, 4.5, and 5 years. The change in refraction over time was estimated by linear mixed model analysis.ResultsIntraocular lens implantation was completed in 56 eyes; 43 were analyzed (median age, 2.4 months; range, 1.0-6.8 months). Exclusions included 11 patients with glaucoma, 1 patient with Stickler syndrome, and 1 patient with an IOL exchange at 8 months postoperatively. The mean rate of change in a myopic direction from 1 month after cataract surgery to age 1.5 years was 0.35 diopters (D)/month (95% confidence interval [CI], 0.29-0.40 D/month); after age 1.5 years, the mean rate of change in a myopic direction was 0.97 D/year (95% CI, 0.66-1.28 D/year). The mean refractive change was 8.97 D (95% CI, 7.25-10.68 D) at age 5 years for children 1 month of age at surgery and 7.22 D (95% CI, 5.54-8.91 D) for children 6 months of age at surgery. The mean refractive error at age 5 years was -2.53 D (95% CI, -4.05 to -1.02).ConclusionsAfter IOL implantation during infancy, the rate of myopic shift occurs most rapidly during the first 1.5 years of life. Myopic shift varies substantially among patients. If the goal is emmetropia at age 5 years, then the immediate postoperative hypermetropic targets should be +10.5 D at 4 to 6 weeks and +8.50 D from 7 weeks to 6 months. However, even using these targets, it is likely that many children will require additional refractive correction given the high variability of refractive outcomes.

| S-EPMC5507620 | biostudies-literature

Outcomes of secondary intraocular lens implantation in the Infant Aphakia Treatment Study.

Project description:PurposeTo report outcomes of secondary intraocular lens (IOL) implantation in the Infant Aphakia Treatment Study (IATS).SettingMulticenter clinical practice.DesignSecondary analysis of patients enrolled in a randomized clinical trial.MethodsDetails regarding all secondary IOL surgeries conducted in children enrolled in the IATS were compiled. Visual outcomes, refractive outcomes, and adverse events at the age of 10½ years were evaluated. Comparisons were made with eyes that remained aphakic and with eyes randomized to primary IOL placement.ResultsThe study included 114 infants, 57 in the aphakic group and 57 in the primary IOL group; 55 of 57 patients randomized to aphakia with contact lens correction were seen for the 10½-year study visit; 24 (44%) of 55 eyes had secondary IOL surgery. Median age at IOL surgery was 5.4 years (range 1.7 to 10.3 years). Mean absolute prediction error was 1.00 ± 0.70 diopters (D). At age 10½ years, the median logarithm of the minimum angle of resolution visual acuity (VA) was 0.9 (range 0.2 to 1.7), similar to VA in the 31 eyes still aphakic (0.8, range 0.1 to 2.9); the number of eyes with stable or improved VA scores between the 4½-year and 10½-year study visits was also similar (78% secondary IOL eyes; 84% aphakic eyes). For eyes undergoing IOL implantation after the 4½-year study visit (n = 22), the mean refraction at age 10½ years was -3.20 ± 2.70 D (range -9.90 to 1.10 D), compared with -5.50 ± 6.60 D (n = 53, range -26.50 to 3.00 D) in eyes with primary IOL (P = .03).ConclusionsDelayed IOL implantation allows a more predictable refractive outcome at age 10½ years, although the range of refractive error is still large.

| S-EPMC7936988 | biostudies-literature

Anisometropia at Age 5 Years After Unilateral Intraocular Lens Implantation During Infancy in the Infant Aphakia Treatment Study.

Project description:To report the prevalence of anisometropia at age 5 years after unilateral intraocular lens (IOL) implantation in infants.Prospective randomized clinical trial.Fifty-seven infants in the Infant Aphakia Treatment Study (IATS) with a unilateral cataract were randomized to IOL implantation with an initial targeted postoperative refractive error of either +8 diopters (D) (infants 28 to <48 days of age) or +6 D (infants 48-210 days of age). Anisometropia was calculated at age 5 years. Six patients were excluded from the analyses.Median age at cataract surgery was 2.2 months (interquartile range [IQR], 1.2, 3.5 months). The mean age at the age 5 years follow-up visit was 5.0 ± 0.1 years (range, 4.9-5.4 years). The median refractive error at the age 5 years visit of the treated eyes was -2.25 D (IQR -5.13, +0.88 D) and of the fellow eyes +1.50 D (IQR +0.88, +2.25). Median anisometropia was -3.50 D (IQR -8.25, -0.88 D); range -19.63 to +2.75 D. Patients with glaucoma in the treated eye (n = 9) had greater anisometropia (glaucoma, median -8.25 D; IQR -11.38, -5.25 D vs no glaucoma median -2.75; IQR -6.38, -0.75 D; P = .005).The majority of pseudophakic eyes had significant anisometropia at age 5 years. Anisometropia was greater in patients that developed glaucoma. Variability in eye growth and myopic shift continue to make refractive outcomes challenging for IOL implantation during infancy.

| S-EPMC5534372 | biostudies-literature

Cost of intraocular lens versus contact lens treatment after unilateral congenital cataract surgery in the infant aphakia treatment study at age 5 years.

Project description:PurposeTo analyze differences in the cost of treatment for infants randomized to primary intraocular lens (IOL) implantation versus optical correction with a contact lens (CL) after unilateral cataract surgery in the Infant Aphakia Treatment Study (IATS).DesignRetrospective cost analysis of a prospective, randomized clinical trial based on Georgia Medicaid reimbursement data as well as actual costs of supplies used during the study, adjusted for inflation.ParticipantsThe IATS is a multicenter (n = 12), randomized clinical trial comparing the optical treatment of aphakia with either primary IOL implantation (n = 57) or CL correction (n = 57) in 114 infants with unilateral congenital cataract.InterventionOne hundred fourteen infants underwent unilateral cataract surgery and were either corrected optically by primary IOL implantation at the time of surgery or were corrected with a CL after surgery.Main outcome measuresThe mean cost of cataract surgery and all additional surgeries, examinations, and supplies used up to 5 years of age.ResultsThe 5-year treatment cost of an infant with a unilateral congenital cataract corrected optically with an IOL was $27 090 versus $25 331 for a patient treated with a CL after initial cataract surgery. The total cost of supplies was $3204 in the IOL group versus $7728 in the CL group.ConclusionsUnilateral cataract surgery in infancy coupled with primary IOL implantation is approximately 7% more expensive than aphakia and CL correction. Patient costs are more than double with CL versus IOL treatment.

| S-EPMC4306643 | biostudies-literature

Intraocular lens-sling technique: A safe approach for lens implantation in complicated cataract surgery and secondary intraocular lens implantation.

Project description:Among 20 million cataract surgeries being performed worldwide every year, approximately 5% are being complicated by posterior capsule rent or zonular dialysis. Intraocular lens (IOL) implantation in such cases with intraoperative complications is quite challenging. Our next course of action is to place the IOL in the ciliary sulcus, however, there is a risk of IOL drop into the vitreous in cases of inadequate support. We have described a novel idea of using a suture material through the dialling hole of a three-piece rigid IOL which can be used as a leash to reduce the risk of IOL drop during implantation in such cases. This technique could also be used during sutureless scleral fixated IOL and retro-pupillary iris claw lens implantation. We found that in 90 consecutive patients where this technique was used, there was no incidence of IOL drop or retinal detachment.

| S-EPMC7210857 | biostudies-literature

Complications, adverse events, and additional intraocular surgery 1 year after cataract surgery in the infant Aphakia Treatment Study.

Project description:PurposeTo compare rates and severity of complications between infants undergoing cataract surgery with and without intraocular lens (IOL) implantation.DesignProspective, randomized clinical trial.ParticipantsThe Infant Aphakia Treatment Study (IATS) is a randomized, multicenter (n = 12) clinical trial comparing treatment of aphakia with a primary IOL or contact lens in 114 infants with unilateral congenital cataract.InterventionInfants underwent cataract surgery with or without placement of an IOL.Main outcome measuresThe rate, character, and severity of intraoperative complications (ICs), adverse events (AEs), and additional intraocular surgeries (AISs) during the first postoperative year in the 2 groups were analyzed.ResultsThere were more patients with ICs (28% vs. 11%; P = 0.031), AEs (77% vs. 25%; P<0.0001), and AISs (63% vs. 12%; P<0.0001) in the IOL group than the contact lens group. Iris prolapse was the most common IC. The most common AE was visual axis opacification, and the most common additional intraocular reoperation was a clearing of visual axis opacification.ConclusionsThe rates of ICs, AEs, and AISs 1 year after surgery were numerically higher in the IOL group, but their functional impact does not clearly favor either treatment group.Financial disclosure(s)The author(s) have no proprietary or commercial interest in any materials discussed in this article.

| S-EPMC3230731 | biostudies-literature

Net technique for intraocular lens support in aphakia without capsular support.

Project description:BackgroundThis paper describes a modified surgical technique for intraocular lens implantation in aphakic eyes with no capsular support.MethodsRetrospective case series. Seventeen eyes of 17 aphakic patients with no capsule support underwent intraocular lens (IOL) implantation using a standardized technique in which a net was created at the ciliary sulcus plane with two threads forming a net pattern. The net was used as support for the IOL. Follow-up ranged from 6 to 38 months, with an average of 23 months.ResultsIn all cases, the IOL was safely implanted and remained stable during the follow-up. In 16 eyes, the IOL remained well centered; in one eye, slight decentration was observed. Distance-corrected visual acuity improved by a mean of 4 lines, from 1.13 (LogMAR) to 0.52 (P = 0.01).ConclusionThis technique might be especially useful in cases of insufficient capsular support associated with tissue loss or iris atrophy. In these cases, iris fixation is not feasible; thus, the only surgical alternative is IOL scleral fixation.

| S-EPMC5572154 | biostudies-literature

Predictability of intraocular lens power calculation formulae in infantile eyes with unilateral congenital cataract: results from the Infant Aphakia Treatment Study.

Project description:To compare accuracy of intraocular lens (IOL) power calculation formulae in infantile eyes with primary IOL implantation.Comparative case series.The Hoffer Q, Holladay 1, Holladay 2, Sanders-Retzlaff-Kraff (SRK) II, and Sanders-Retzlaff-Kraff theoretic (SRK/T) formulae were used to calculate predicted postoperative refraction for eyes that received primary IOL implantation in the Infant Aphakia Treatment Study. The protocol targeted postoperative hyperopia of +6.0 or +8.0 diopters (D). Eyes were excluded for invalid biometry, lack of refractive data at the specified postoperative visit, diagnosis of glaucoma or suspected glaucoma, or sulcus IOL placement. Actual refraction 1 month after surgery was converted to spherical equivalent and prediction error (predicted refraction - actual refraction) was calculated. Baseline characteristics were analyzed for effect on prediction error for each formula. The main outcome measure was absolute prediction error.Forty-three eyes were studied; mean axial length was 18.1 ± 1.1 mm (in 23 eyes, it was <18.0 mm). Average age at surgery was 2.5 ± 1.5 months. Holladay 1 showed the lowest median absolute prediction error (1.2 D); a paired comparison of medians showed clinically similar results using the Holladay 1 and SRK/T formulae (median difference, 0.3 D). Comparison of the mean absolute prediction error showed the lowest values using the SRK/T formula (1.4 ± 1.1 D), followed by the Holladay 1 formula (1.7 ± 1.3 D). Calculations with an optimized constant showed the lowest values and no significant difference between the Holladay 1 and SRK/T formulae (median difference, 0.3 D). Eyes with globe AL of less than 18 mm had the largest mean and median prediction error and absolute prediction error, regardless of the formula used.The Holladay 1 and SRK/T formulae gave equally good results and had the best predictive value for infant eyes.

| S-EPMC4140419 | biostudies-literature

Cataract Surgery with or without Intraocular Lens Implantation in Pediatric Uveitis: A Systematic Review with Meta-Analyses.

Project description:PurposeTo systematically review the results of comparative studies of modern cataract surgery in pediatric uveitis with or without intraocular lens (IOL) implantation and to perform comparative meta-analyses to compare visual acuity outcomes and complication rates.MethodsOn 12 November 2020, we systematically searched the Cochrane Central, PubMed/MEDLINE, EMBASE, ClinicalTrials.gov, and all affiliated databases of the Web of Science. Two authors independently reviewed studies and extracted data. Studies were reviewed qualitatively in text and quantitatively with meta-analyses. Outcome measures were preoperative and postoperative best-corrected visual acuity (BCVA), inflammation control, and rates of postoperative complications.ResultsTen studies of 288 eyes were eligible for review of which the majority were eyes with juvenile idiopathic arthritis-associated uveitis. Summary estimates revealed that the BCVA was better in pseudophakic eyes vs. aphakic eyes (1-year postoperative: -0.23 logMAR, 95% CI: -0.43 to -0.03 logMAR, P=0.027; 5-year postoperative: -0.35 logMAR, 95% CI: -0.51 to -0.18 logMAR, P=0.000036). Pseudophakic eyes had more visual axis opacification (OR 6.76, 95% CI: 2.73 to 16.8, P=0.000036) and less hypotony (OR 0.19, 95% CI: 0.04 to 0.95, P=0.044).ConclusionsIn modern era cataract surgery on eyes with pediatric uveitis with IOL implantation leads to satisfactory and superior visual outcomes and no differences in complication rates apart from an increased prevalence of visual axis opacification and a decreased prevalence of hypotony when compared to aphakia. However, limitations of the retrospective design and the presence of selection bias necessitate a careful interpretation.

| S-EPMC8213487 | biostudies-literature

Macular pigment changes after cataract surgery with yellow-tinted intraocular lens implantation.

Project description:PurposeWe previously reported that macular pigment optical density (MPOD) levels decreased during a long follow-up period after clear intraocular lens (IOL) implant surgery presumably due to excessive light exposure. We examined changes in MPOD levels in the eyes that received yellow-tinted IOL implant surgery.Subjects and methodsThis was a prospective, observational study. Fifty-five eyes of 35 patients were studied. MPOD levels were measured with a dual-wavelength autofluorescence technique on day 4; months 1, 3, and 6; and years 1 and 2 postoperatively. The average optical densities at 0°- 2° eccentricities (local MPODs) and total volumes of MPOD (MPOVs) in the area within 1.5° and 9° eccentricities were analyzed.ResultsThe mean local MPOD at baseline (on day 4) was 0.79 at 0°, 0.71 at 0.5°, 0.68 at 0.9°, and 0.32 at 2°. The mean MPOV within 1.5° and 9° at baseline was 2950 and 18,897, respectively. Local MPOD at 0.9° and 2° and MPOVs were slightly decreased at month 1 and increased after that. The increase reached statistical significance in local MPOD at 0.5° and 2° and MPOVs (Tukey-Kramer test). The changes in MPOV within 9° at year 2 [(MPOV on year 2 - MPOV on day 4) / MPOV on day 4] were from -0.21 to 1.18 (mean and standard deviation: 1.14 ± 0.28). The MPOV of 15 eyes increased more than 10% from the initial value, was maintained within 10% in 21 eyes, and deteriorated more than 10% in only 3 eyes.ConclusionsLocal MPOD and MPOV tended to slightly decrease month 1 postoperatively and gradually increased after that, but the rates of increases in MPOD levels were small. Yellow-tinted IOLs that have a lower transmittance of blue light might be preferable for preserving MPOD levels after surgery.

| S-EPMC7993776 | biostudies-literature

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