Clinical Outcomes After Bilateral Implantation of a Diffractive Trifocal Intraocular Lens: A Worldwide Pooled Analysis of Prospective Clinical Investigations.

Purpose: To investigate visual and safety outcomes of AcrySof® IQ PanOptix® (model TFNT00), a trifocal, presbyopia-correcting intraocular lens (IOL), in patients of different ethnicities across multiple countries, based on a pooled analysis of six prospective multicenter studies. Patients and Methods: This pooled analysis included adult patients from six prospective clinical studies performed across 56 centers worldwide. After cataract removal by phacoemulsification, all patients were implanted with TFNT00; follow-up duration varied from 3 to 12 months according to the studies' design. Binocular defocus curve; absolute manifest refraction spherical equivalent (MRSE); and binocular photopic uncorrected and corrected visual acuities at distance (UCDVA, BCDVA; 4-5 m), intermediate (UCIVA, DCIVA; 60-66 cm), and near (UCNVA, DCNVA; 40 cm) were measured. Results: The study included 557 patients, 547 of whom were implanted bilaterally with the TFNT00 IOL (n = 1094 eyes). Binocular visual data at 1 month and 3-6 months after implantation were available for up to 546 and 542 bilaterally implanted patients, respectively. A continuous range of 0.1 logarithm of the minimum angle of resolution (logMAR) or better vision from distance (0.00 diopter [D], 4-5 m) to near (-3.00 D; optically equivalent to 33 cm) was observed 3-6 months after TFNT00 implantation. At 3-6 months, 88.2% of first eyes achieved an MRSE ≤0.50 D and 88.7% of second eyes achieved an MRSE ≤0.50 D. Overall, 99.3%, 92.3%, and 94.6% of patients bilaterally implanted with TFNT00 achieved binocular photopic BCDVA, DCIVA, and DCNVA of 0.14 logMAR or better, respectively. Ocular adverse device effects and secondary surgical interventions (SSIs) were infrequent. Conclusion: This global pooled analysis showed that TFNT00 provided a continuous range of 0.1 logMAR (~20/25 Snellen) or better vision from distance to 33 cm, with a low incidence of ocular adverse device effects and SSIs.

Twelve-Months Follow-Up Postmarket Study of a Hydrophobic Intraocular Lens Using a Preloaded Automated Injector in an Indian Population.

Purpose: To assess real-world clinical outcomes and safety of the Clareon® intraocular lens (IOL) and AutonoMe® automated preloaded delivery system in an Indian population. Patients and methods: This was a prospective, single-arm, multicenter, 12-month clinical study in patients aged ≥20 years with unilateral or bilateral cataracts. Surgery was performed by phacoemulsification followed by implantation of the Clareon monofocal IOL (CNA0T0). Monocular best-corrected distance visual acuity (BCDVA) and uncorrected distance visual acuity (UCDVA) were assessed at 1 week and 1, 6, and 12 months after implantation. Posterior capsular opacification (PCO), surface haze, and glistenings were evaluated at all visits. Surgeons' satisfaction with automated injector system was also evaluated using a questionnaire. Safety was assessed by monitoring adverse events (AEs). Results: A total of 151 eyes received the CNA0T0 IOL. Mean ± SD monocular BCDVA improved from 0.53±0.44 logMAR preoperatively to 0.00±0.08 logMAR at week 1 and -0.03±0.08 logMAR at 12 months after implantation. At 12 months, 137/137 (100%) of eyes achieved BCDVA of 0.3 logMAR or better. Mean ± SD monocular UCDVA was 0.78±0.40 logMAR preoperatively, 0.11±0.15 logMAR at week 1, and 0.08±0.13 logMAR at 12 months after implantation. At 12 months, 132/137 (96%) eyes achieved UCDVA of 0.3 logMAR or better. Serious intraoperative AEs were posterior capsule rupture (n=1) and ciliary zonular dehiscence (n=1). Surgeons reported that the automated preloaded device was more intuitive compared with other push- or screw-style preloaded injector systems. None of the eyes in this study presented surface haze; all were graded as 0 glistenings at all visits. No clinically significant PCO or neodymium-doped yttrium aluminum garnet (Nd:YAG) capsulotomies were reported. Conclusion: The hydrophobic IOL preloaded in an automated injector system provided good visual and refractive outcomes, as well as no surface haze and grade 0 glistenings. None of the patients required Nd:YAG capsulotomy.

A Preliminary Study on the Outcome of Plication Augmentation of the Augmented Anderson Procedure for Patients with Infantile Nystagmus Syndrome and a Face Turn.

PURPOSE: To report the results of plication augmentation of the augmented Anderson procedure in patients with infantile nystagmus syndrome and face turn. METHODS: In this retrospective study, all patients who underwent plication augmentation of the augmented Anderson procedure between August 2015 and November 2018 were included. Our study included patients older than 6 years with a face turn >25°. We also included patients with residual face turns ≥15° after Anderson-type procedures. The face turn was measured by a goniometer and also quantified with prisms placed with apex in the direction of the face turn. We plicated the medial rectus of one eye by 5.0 mm and lateral rectus of the fellow eye by 7.0 mm based on the direction of the face turn in addition to the augmented Anderson procedure. Patients were reviewed on the 1st postoperative day, 1st month, and every 6 months thereafter. RESULTS: Eight patients with a mean face turn of 27.5° ± 6.5° underwent plication augmentation of the augmented Anderson procedure. Two patients had residual face turns after a previous Anderson-type procedure. We obtained a mean correction of 25° ± 6.5° with a median prismatic correction of 45 prism diopters (PD) for each eye. The median face turn at the last review was 2.5°, and all patients were corrected to within 10°. Excluding patients operated for residual face turns, we had a mean dose response of 2.7 PD/mm and 1.7°/mm of surgery on each eye. Five patients had an improvement in null zone visual acuity. Two patients had a restriction in ocular motility of -2 in the direction of the recessed extraocular muscle at the last review, and the remaining had a -1 restriction. CONCLUSIONS: Plication augmentation of the augmentation Anderson procedure appears to be a safe and effective procedure for patients with infantile nystagmus syndrome and a face turn more than 25°. It may also be used for residual face turns more than 15°.

Clinical Outcomes After Bilateral Implantation of a Trifocal Presbyopia-Correcting Intraocular Lens in an Indian Population.

PURPOSE: To evaluate the effectiveness and safety of a presbyopia-correcting trifocal intraocular lens (IOL), AcrySof® IQ PanOptix® (TFNT00), in an Indian population. PATIENTS AND METHODS: This prospective, multicenter, observational, single-arm, post-marketing study included 67 patients undergoing cataract surgery with bilateral implantation of TFNT00 across five Indian sites. Postoperative outcomes were assessed at 3 months after second eye surgery. Effectiveness outcomes included: mean binocular and monocular visual acuity (VA) at distance (4 m), intermediate (60 cm), and near (40 cm); binocular defocus curve; manifest refraction; and subjective symptom questionnaire evaluation. Safety outcomes included the rate of ocular adverse events and mesopic contrast sensitivity. RESULTS: Mean binocular and monocular distance-corrected and uncorrected VAs of 0.1 logMAR or better (approximately 20/25 Snellen) were achieved at distance, intermediate, and near. Overall, ≥70% of patients achieved binocular 0.1 logMAR vision or better across all distances. TFNT00 maintained a mean VA of 0.1 logMAR or better at the defocus range of +0.5 diopters (D) to -2.5 D (200 cm to 40 cm). The subjective symptom questionnaire-assessed frequency of halo visual disturbances was low at Month 3; halos were reported "none of the time" to "only some of the time" in 86.6% of patients. The large majority of patients (98.5%) were "satisfied" or "very satisfied" with their near, intermediate, and distance vision at Month 3, and ≥94.0% of patients reported spectacle independence for tasks at all distances. The adverse event rate was low; no patients discontinued due to an adverse event. CONCLUSION: TFNT00 provided a continuous range of vision of 20/25 or better for distance to near and performed effectively at an intermediate functional distance of 60 cm, resulting in high levels of spectacle independence and patient satisfaction. TFNT00 demonstrated a good safety profile and a low post-operative frequency of halo visual disturbances.

Profile of infectious and sterile keratitis after accelerated corneal collagen cross-linking for keratoconus.

PURPOSE: The aim of this study was to assess the potential risk factors and causes of infectious and sterile keratitis after accelerated collagen cross-linking. METHODS: Case records of 968 eyes that underwent accelerated corneal collagen cross-linking (ACXL) over the period of 4 years were reviewed retrospectively. ACXL was done using (Avedro KXL® system, Waltham, MA, USA) 9 mW/cm2 for 10 min protocol providing total energy of 5.4 J/cm2. RESULTS: Of 968 eyes, a total of three eyes developed infectious keratitis and seven eyes developed sterile infiltrates. Three of this infectious keratitis had two cases which were resistant to fourth-generation fluoroquinolones. Seven cases of sterile infiltrates had excellent resolution after treatment with topical steroids. Sterile infiltrates were common in corneas with thinnest pachymetry of <400 µm, except in one case of intra stromal corneal ring segments (INTACS) + ACXL. CONCLUSION: Judicious use of steroids in the initial postoperative period is recommended so as to prevent any form of microbial keratitis. Very steep corneas and too thin corneas should be looked with high index of suspicion in view of chances of developing sterile infiltrates.

Deep anterior lamellar keratoplasty outcomes in macular and granular corneal dystrophy - A comparative cross-sectional study.

Purpose: To compare the functional and anatomical outcomes (in terms of graft uptake and rejection/failure) of deep anterior lamellar keratoplasty (DALK) in stromal corneal dystrophy (macular and granular). Methods: Sixteen eyes with macular corneal dystrophy (MCD; group A) and 10 eyes with granular corneal dystrophy (GCD; group B) underwent successful DALK by big bubble technique or layer-by-layer dissection. Results: Both groups showed significant improvement in their best-corrected visual acuity postoperatively (postoperative P value in MCD and GCD was 0.00001 and 0.0008, respectively) with no statistically significant differences between the two groups (P = 0.77) at 1 year. Postoperative endothelial count did not drop significantly in group A (MCD, P= 0.1553). Only in seven eyes preoperative endothelial count could be obtained (due to dense stromal corneal opacity), but there was a significant endothelial count difference between preoperative and postoperative count in group B (GCD, P= 0.0405) at the end of 1 year postoperatively which could be because of age and stage of disease (advanced granular dystrophy) and also because of small sample size of GCD compared with MCD. Intergroup comparison between the two groups showed no statistically significant difference (P = 0.6353) with good postoperative outcome in both groups. Conclusion: DALK can be successfully done in both groups and results are comparable. However, long-term outcomes on a large scale need to be further evaluated.

Cannula-vacuum continuous curvilinear capsulorhexis: Inexpensive technique for intumescent total cataract.

We report a new, inexpensive technique for creating a continuous curvilinear capsulorhexis (CCC) for intumescent total cataract. Peribulbar anesthesia is administered. A nick is created using a regular 26-gauge cystotome. Through a side port, the free capsule flap is vacuumed using the flat tip of a 25-gauge round cannula connected to a 5 mL syringe. Suction pressure is created by withdrawing the piston of the syringe in a controlled motion to create a curvilinear capsulorhexis without withdrawing the instrument from the anterior chamber. Next, liquefied cortex is aspirated with the same cannula. Complete vacuum was achieved with the cannula in 197 (98.5%) of 200 cases; 3 cases (1.5%) had capsulorhexis extension and vacuum was not achieved. The new cannula-vacuum CCC technique is safe and affordable and might be an alternative to conventional CCC performed using a 26-gauge cystotome or a Utrata or micro capsulorhexis forceps.

Long-term safety of posterior chamber implantable phakic contact lens for the correction of myopia.

PURPOSE: To review the safety of the implantable phakic contact lens (IPCL V1, Caregroup Sight Solutions, India) for correction of myopia and myopic astigmatism. METHODS: Retrospective interventional case series including 134 eyes which underwent IPCL implantation for correction of myopia and myopic astigmatism at a tertiary eye care hospital in South India. Intraoperative and postoperative complications were analyzed. The following parameters were analyzed at preoperative and 1, 6 and 12 month postoperative visits: visual acuity (in logMAR) and manifest refraction, slit lamp bio microscopy, dilated fundus examination, IOP and endothelial cell density measurement. RESULTS: No intraoperative complications were noted. Cataract was the most common postoperative complication, wherein three eyes (2.2%) underwent observation for visually insignificant anterior subcapsular cataract and one eye (0.7%) required surgical intervention. Four eyes developed transient increased IOP due to steroid response (3 eyes) and pupillary block glaucoma (1 eye). The endothelial cell loss noted over a 1-year follow-up was 2.01%±4.12% (P=0.71). One eye developed hypopyon on the third postoperative day, which resolved subsequently with an unaided vision of 20/20. No vision threatening complications were noted. The mean follow-up in the cohort was 25.66±16.45 months. CONCLUSION: The IPCL is a safe and effective treatment modality for correction of myopia and myopic astigmatism.

Long-term analysis of an unconventional way of doing double-head pterygium excision.

AIM: The aim of the study is to describe an unconventional technique of vertically split conjunctival autograft (CAG) for primary double-head pterygium and its long-term outcome. MATERIALS AND METHODS: This was a retrospective, noncomparative, interventional case series of 95 eyes of 95 patients, who underwent vertical, split CAG surgery without maintaining limbus-limbus orientation for primary double-head pterygium from January 2013 to January 2017. All patients were reviewed for recurrence in their follow-up period. RESULTS: The mean follow-up was 14.12 ± 9.42 months. The baseline characteristics included 44 males and 51 females, with a mean age of 56.24 ± 10.03 years. The only significant complication was recurrence rate of 2.10% (2 eyes out of 95). The most common secondary outcome was graft edema (36.84%, 35 eyes out of 95), which resolved without any intervention. The other outcomes such as graft retraction (12.63%), Tenon's granuloma (1.05%), and subconjunctival hemorrhage (34.73%) were also recorded. CONCLUSION: Unconventional vertical split CAG without maintaining limbus-limbus orientation has convincing results in treating double-head pterygium with lower recurrence rate.

Outcome of deep anterior lamellar keratoplasty patients with intraoperative Descemet's membrane perforation: A retrospective cross-sectional study.

PURPOSE: To evaluate functional and anatomical outcome in patients undergoing deep anterior lamellar keratoplasty (DALK) with intraoperative Descemet's membrane (DM) perforation (macro and micro). METHODS: A retrospective cross sectional study (January 2009 to December 2015) of sixteen eyes of sixteen patients which included nine patients of advanced keratoconus (KC), two patients with paracentral DM scarring post hydrops, KC with Bowman's membrane scarring, macular corneal dystrophy and one patient of advanced Pellucid Marginal Degeneration (PMD). All underwent DALK with intraoperative DM perforation. Big bubble technique was attempted in all except in the two patients with post hydrops DM scar. Preoperative and postoperative best corrected visual acuity (BCVA), astigmatism and endothelial count (EC) were compared. RESULTS: Postoperative BCVA and astigmatism were found to be better and statistically significant ('p value' 0.00 and 0.003 respectively). BCVA preoperative and postoperative was 1.07± 0.3 and 0.28 ± 0.09 in LogMAR respectively and astigmatism pre and postoperative 4.14 ± 1.5 D and 2.7 ± 0.97 D respectively. Percentage decrease in EC at sixth postoperative week was 7.48% and at sixth month and 1 year postoperative was 15.1%. Two patients developed postoperative double anterior chamber and two patients developed pupillary block glaucoma and all were successfully managed. CONCLUSION: Not all patients of intraoperative DM perforation (including macro perforation) needs to be converted to penetrating keratoplasty. DALK can be successfully done if the perforation is identified early and managed adequately. This is the only known study which has shown a large series of successful DALK even with macro perforations.

Concomitant use of conjunctival tissue graft from the pterygium itself without rotation in pterygium surgery: A full circle in conjunctival autografting.

Purpose: The aim of this study is to describe a modified technique of using conjunctival tissue from the pterygium itself without any rotation of graft for the primary pterygium in eyes with glaucoma filtering bleb, glaucoma suspects, and in primary double-head pterygium using fibrin glue. Methods: In this retrospective, noncomparative, interventional case series, 98 eyes of 98 patients with primary pterygium operated between July 2011 to July 2016 were included. They underwent this technique from the pterygium tissue itself. There was no rotation of this graft, and it was adhered to the bare scleral defect with fibrin glue. Histopathological analysis of pterygium tissue was done to look for morphology and thickness of this thin conjunctival tissue obtained from pterygium tissue itself. The primary outcome measure was recurrence rate. Other outcome measures studied was graft retraction and graft edema. Results: The mean age was 52 ± 10.04 years. Mean follow-up was 14 ± 8.24 months. The only significant complication was recurrence rate of 4.08% (4 eyes out of 98). The most come secondary outcome was graft edema, 52.04% (51 eyes out of 98) which resolved without any intervention. Other outcome such as graft retraction, 32.65% was also recorded. Conclusion: Conjunctival tissue from the pterygium tissue itself without actual rotation appears to be a successful technique with lower recurrence rate for treating primary pterygium in eyes with glaucoma filtering bleb, glaucoma suspects, and in primary double-head pterygium.

Double-head pterygium excision with modified vertically split-conjunctival autograft: Six-year long-term retrospective analysis.

PURPOSE: The aim of this study is to describe a modified technique of vertically split-conjunctival autograft (CAG) for primary double-head pterygium and evaluate its postoperative outcome. METHODS: In this retrospective, noncomparative, interventional case series, 87 eyes of 87 patients of double-head pterygium from June 2009 to June 2015 were included. They underwent vertical split CAG. A limbus-limbus orientation was not strictly maintained. Primary outcome measure was recurrence rate. Other outcome measures studied were graft retraction, Tenon's granuloma, dellen, and so on. RESULTS: Mean age was 54.54 ± 11.51 years; M:F was 41:46. Mean follow-up was 17.28 ± 10.28 months. The only significant complication was recurrence rate of 3.45% (3 eyes out of 87). Other most common secondary outcome was graft edema, 42.52% (37 eyes out of 87) which resolved without any intervention. Other outcomes such as graft retraction (31.03%), dellen (1.15%), Tenon's granuloma (3.45%), and subconjunctival hemorrhage (36.78%) were recorded. CONCLUSION: Modified vertical split CAG without maintaining limbus-limbus orientation, just large enough to cover the bare scleral defect, appears to be a successful technique with lower recurrence rate in treating double-head pterygium.

Residency evaluation and adherence design study: Young ophthalmologists' perception of their residency programs - Clinical and surgical skills.

BACKGROUND: Residency training is the basis of good clinical and surgical practice. PURPOSE: The aim is to know the demographics, training experience, and perception of young ophthalmologists to improve the present residency programs in India. SETTING: Young ophthalmologists trained in India. METHODS: A survey was conducted by the Academic and Research Committee of the All India Ophthalmology Society, in 2014-2016 of young ophthalmologists (those trained between 2002 and 2012, with 2-10 years' postresidency experience) to gauge teaching of clinical and surgical skills during the postgraduate residency program. STATISTICAL ANALYSIS: Statistical Package for Social Sciences version 16. RESULTS: Of the 1005 respondents, 531 fulfilled inclusion criteria. Average age was 32.6 years (standard deviation [SD] 4). On a scale of 0-10, clinical skills teaching was graded as (mean, SD): Slit lamp examination (7.2, SD 2.8), indirect ophthalmoscopy (6.2, SD 3.3), gonioscopy (5.7, SD 3.4), perimetry (6.2, SD 3.2), optical coherence tomography (4.6, SD 4), and orthoptic evaluation (4.3, SD 3.1). The mean (SD) and median of surgeries performed independently was intracapsular cataract extraction 3.0 (14.9), 0; extracapsular cataract extraction 39.9 (53.2), 18; small incision cataract surgery 75.3 (64.4), 55; phacoemulsification 30 (52.6), 1; pterygium excision 31.5 (43.5), 15; dacryocystectomy 20.3 (38.1), 4; dacryocystorhinostomy 11.7 (26.2), 2; chalazion 46.4 (48.3), 30; trabeculectomies 4 (14.9), 0; strabismus correction 1.4 (4.9), 0; laser-assisted in situ Keratomileusis 1.5 (12.2), 0; retinal detachment 1.5 (12.5), 0; vitrectomy 3.0 (17.0), 0; keratoplasty 5.2 (17.8), 0; eyelid surgery 8.6 (18.9), 2 and ocular emergencies 41.7 (52.4), 20. Observed and assisted surgeries were more common. However, the range of grading was 0-10 in all categories. CONCLUSION: Residency training in India varies considerably from program to program. Standardization is needed to assure all graduates are competent and render consistent quality of service.