Poor intraoperative visibility and postoperative astigmatism associated with trabecular micro-bypass stent for corneal dystrophy: A case report.

RATIONALE: There are reports of safe cataract surgery in eyes with posterior polymorphous corneal dystrophy (PPCD); however, to our knowledge, there are no reports of minimally invasive glaucoma surgery (MIGS) in eyes with PPCD. Herein, we report a case of poor intraoperative visibility with gonioscopy, postoperative corneal edema, and corneal astigmatism in eyes with PPCD treated with trabecular micro-bypass stent combined with cataract surgery. PATIENT CONCERNS/DIAGNOSIS: A 78-year-old man was referred to our hospital for MIGS. He presented with bilateral corneal endothelial vesicular changes and band lesions. Endothelial cell density was 2983/2871 cells/mm2 (right/left eye), central corneal thickness was 581 µm/572 µm, best-corrected visual acuity values (Snellen equivalent) were 20/32 (right) and 20/100 (left), and corneal astigmatism was -2.7D in the right eye and -2.5D in the left eye. INTERVENSIONS/ OUTCOMS: After phacoemulsification and aspiration with intraocular lens implantation with a 2.4-mm corneal incision in both eyes, trabecular micro-bypass stents were inserted successfully despite the poor intraoperative visibility with gonioscopy. One week after surgery, the central corneal thickness was 614 µm/609 µm, and Descemet's membrane folds and mild corneal edema were observed. Best-corrected decimal visual acuity was 20/40 for the right eye and 20/50 for the left eye. In the left eye, total corneal astigmatism increased from -2.5D to -5.5D. Corneal astigmatism and edema showed gradual improvement. LESSONS: Although reports have shown that cataract surgery can be safely performed in eyes with PPCD, MIGS in eyes with PPCD may require caution regarding intraoperative visibility with gonioscopy and visual function in the early postoperative period.

Tear film assessment before and after phacoemulsification in patients with age-related cataracts.

BACKGROUND: The study aims to assess the tear film before and after phacoemulsification in patients with age-related cataracts. METHODS: A prospective observational study of 41 age-related cataract patients undergoing phacoemulsification procedure. Tear Film Break-Up Time (TBUT), Tear Film Meniscus Height (TMH), Meibomian glands (MG), and Lipid Layer Thickness (LLT) were assessed by a non-invasive Dry Eye Diagnostic System. All measurements were taken preoperatively, one week, one month, and three months postoperatively. The Marginal homogeneity and The Cochran Q tests were used in the statistical analysis. RESULTS: The value of Non-Invasive Break-Up Time (NITBUT) was statistically significantly lower at one week (7.15 ± 3.31), one month (7.61 ± 3.41), and three months (7.66 ± 3.36) postoperatively than preoperatively (10.71 ± 2.71), p < 0.001. The Non- Invasive Tear Meniscus Height (NITMH) was significantly lower at one week (0.18 ± 0.0), one month (0.20 ± 0.09), and three months (0.20 ± 0.09) postoperatively than preoperatively (0.30 ± 0.113) p < 0.001. By the first month, both (NITBUT) and (NITMH) improved significantly compared to the first post-operative week. There was no statistically significant difference between one month and three months. The (NITMH) improved to a healthy level of ≥ 0.2 mm by the first month through the third month. Both (NITBUT) and (NITMH) did not reach the baseline by the third month. The meibomian glands and the lipid layer thickness had the same preoperative grade distribution without changes. CONCLUSION: Phacoemulsification surgery can cause post-operative deterioration in the tear film, which starts within a week of the procedure, followed by gradual recovery over the next weeks and months. The phacoemulsification procedure mainly affects the tear break-up time and tear meniscus height. Both the lipid layer and meibomian glands are not affected.

Examination of phacoemulsification tips after different numbers of cataract surgeries.

To compare unused phacoemulsification tips and those used different times with different techniques of cataract surgery (divide and conquer and chop), in vivo phacoemulsifications were performed with tips of different numbers of operation. These were compared with the same number of sterilized-only and unused tips with the help of an atomic force microscope. Comparison of roughness values (Sa, Sq), geometric and measurable flange length and surface was also performed (profile length %, area %). The differences between the parameters that can be measured during surgery (average ultrasound percentage, US ave %, Average Phaco Time, APT) were also analyzed. We found significant correlations between age and lens hardness (p = 0.0045), area % and APT (p = 0.03), between area % and US ave% (p = 0.03) and also between the two surgical techniques in terms of area% (p = 0.04) and US ave % (p < 0.01). Roughness increased with the number of uses. An increase in profile length% can be observed up to the twentieth operation. This can result from scratches and microscopic damages and also from abrasion and possible material additions on the surface of the needles. The divide and conquer technique causes less microscopic damage to the surface, and smaller average US energy is required during surgery.

Application of sutureless corneal incision for patients with congenital ectopia lentis - Is it feasible, effective and safe?

Purpose: To compare the clinical outcomes, feasibility, and safety between groups with sutured and sutureless wound closure in congenital ectopia lentis (CEL) patients. Methods: Patients with CEL who received phacoemulsification combined with intrascleral fixation of capsular hook (CH) and implantation of capsular tension ring (CTR) and in-the-bag intraocular lens (IOL) were included in this study. Results: A total of 68 eyes of 34 patients aged 18 years or younger were enrolled in this study. Incisions of 21 patients (34 eyes) did not require sutures while sutures were applied in 21 patients (34 eyes). Postoperative uncorrected distance visual acuity, best corrected distance visual acuity and intraocular pressure measurements were comparable on follow-up visits (P > 0.05). The magnitude of surgically induced astigmatism was significantly greater (P = 0.001) in the suture group (Median: 0.47; IQ: 1.63, 2.97) than in the sutureless group (Median: 0.88; IQ: 0.63, 1.35). No cases of endophthalmitis and retinal detachment were found postoperatively in either group, while suture-related complications were observed in the sutured group, including loose suture with discomfort in 5 (14.71%) eyes, loose suture with mucus infiltration in 3 (8.82%) eyes. In total, 22 sutures (64.71%) of 34 eyes required removal. Conclusions: Sutureless clear corneal incision in CEL patients can achieve satisfactory clinical results comparable to sutured wound closure in terms of the efficacy and safety. Advantages of this approach are the reduced risk of suture-related complications, no need for additional surgery under general anesthesia for suture removal, and less cost.

Nucleus drop following phacoemulsification surgery: Incidence, risk factors and clinical outcomes.

PURPOSE: To determine the incidence, risk factors and clinical outcomes in patients with nucleus drop (ND) following phacoemulsification surgery at a tertiary care ophthalmic institute. METHODS: Medical records of patients with ND during phacoemulsification between January'2019 and December'2022 were reviewed retrospectively. Incidence of ND was calculated overall, and according to surgical expertise levels and surgical steps. Associated pre- and intra-operative risk factors were assessed. Clinical outcome parameters [best-corrected visual acuity (BCVA) and intraocular pressure (IOP)] were compared with respect to timing of PPV (immediate vs early vs delayed), location (sulcus vs scleral fixated-IOL) and timing of IOL placement (primary vs secondary). RESULTS: Among 93,760 phacoemulsifications, ND was noted in 130 patients (0.1%). Significant direct and associated pre-operative risk factors were advanced cataract, glaucoma, posterior polar cataract, and diabetes mellitus. Junior medical consultants had 40 ND (mostly in non-complex cases), whereas senior medical consultants had 90 ND (mostly in complex cases). ND most frequently occurred during emulsification of nuclear fragments. Sulcus placement of IOL during primary surgery yielded significantly better visual outcome compared to secondary procedures, although timing of PPV had insignificant effect. 77.1% had BCVA of 6/12 or better at final follow-up. Timing of IOL implantation, PPV, and type of IOL did not have any significant effect on IOP. CONCLUSIONS: Though the incidence of ND is low, it is a dreaded complication. Accurate pre-operative evaluation, risk stratification, distribution of cases among surgeons based on their surgical expertise, and immediate or early management of ND yields better anatomical and functional outcomes.

Ocular characteristics and outcomes of phacoemulsification in patients with cataract after renal transplantation.

PURPOSE: To explore ocular characteristics of patients with cataracts after renal transplantation and analyze the results of phacoemulsification combined with intraocular lens (IOL) implantation. METHODS: Patients with cataracts after renal transplantation and control patients who underwent phacoemulsification combined with IOL implantation were enrolled. All patients underwent phacoemulsification combined with IOL implantation. Visual acuity, intraocular pressure, type of lens opacity, corneal endothelial cell density, and ocular biological parameters were evaluated before surgery. Visual prognosis, dry eye, and postoperative complications were monitored for 6 months after phacoemulsification. RESULTS: We analyzed 25 eyes of 16 patients after renal transplantation and 30 eyes of 21 control patients. The most common type of cataract of renal transplantation group was posterior subcapsular, while the most common type of cataract of control group was cortical. Significant differences in corneal astigmatism, white-to-white ratio, and keratometry values were observed between the groups. The postoperative visual acuity of both groups significantly improved following surgery. Postoperative complications, such as the degree of anterior and posterior capsule opacification and the incidence of a requirement of neodymium-doped yttrium aluminum garnet laser capsulotomy, were significantly lower in the renal transplantation group. Moreover, secondary glaucoma occurred in two eyes in the renal transplantation group. CONCLUSION: This study showed that cataracts after renal transplantation were mostly posterior subcapsular. Postoperative visual acuity recovered well in most patients, with reduced incidence of postoperative complications. This study suggested that phacoemulsification combined with IOL implantation was safe and effective, providing a reference for multi-focal IOL implantation in kidney transplant recipients.

Minimally invasive bleb surgery versus minimally invasive glaucoma surgery: a 12-month retrospective study.

This study aimed to compare the IOP-lowering effectiveness and safety of standalone Preserflo MicroShunt and iStent 1st generation implantation combined with phacoemulsification in Caucasian patients with a 12-month follow-up period. This retrospective study analyzed the medical histories of patients undergoing antiglaucoma surgery at the Department of Ophthalmology, Medical University of Bialystok, between January 2019 and January 2022. The main outcome measures were success rates (complete: proportion of eyes with IOP < 18 mmHg (criterion A) and < 15 mmHg (criterion B) or 20% reduction in IOP without any glaucoma medication; qualified: proportion of eyes achieving IOPs < 18 mmHg and < 15 mmHg or 20% reduction in IOP from baseline with or without medications), mean reduction (%) in IOP, medication burden, number of complications and additional interventions. In both groups, a significant decrease in IOP and medication burden were observed at 6 and 12 months when compared with baseline. At 12 months, qualified surgical success in criterion A was recorded in 67.4% and 85.7% of patients in the Preserfo and iStent groups, respectively (p = 0.045). Complete surgical success in criterion B at 12 months accounted to 61.4% of patients from Prserflo group and 32.7% patients in iStent group (p = 0.04). Surgical failure at 12 months was documented in 30.2% and 6.3% of patients, respectively (p = 0.003). There was a significant difference between groups in %IOP reduction after 12 months. Greater reduction was observed in Preserflo group, MD = - 8.41 CI95 [- 15.88; - 0.95], p = 0.028, (- 33.49% ± 21.59 vs - 25.07% ± 14.15 in iStent group). Both procedures effectively reduced IOP and postoperative use of antiglaucoma medications in glaucoma patients.

A Shape Memory Polymeric Shield for Protecting Corneal Endothelium During Phacoemulsification.

Background: The purpose of this study was to explore the protective effect of a shape memory polymeric shield on corneal endothelium during phacoemulsification in rabbits. Methods: Poly-(glycerol dodecanedioate) (PGD) with a transition temperature of 24.416°C was prepared to make a shape memory shield with a thickness of 100 µm, an arc length of 14 mm, and a radius of curvature of 8.8 mm. In the control group, a phaco-tip with bevel-down was used to simulate injury to the corneal endothelium by phacoemulsification in rabbits. In the experimental group, the pre-cooled and curled shape memory shield was injected into and removed from the anterior chamber before and after phaco-power release. Anterior segment optical coherence tomography (AS-OCT), confocal microscope, trypan blue/alizarin red staining, and scanning electron microscope were performed to measure endothelial damage after surgery. Results: One day postoperatively, the lost cell ratio of the control group and the experimental group were 28.08 ± 5.21% and 3.50 ± 1.43%, respectively (P < 0.0001), the damaged cell ratios were 11.83 ± 2.30% and 2.55 ± 0.52%, respectively (P < 0.0001), and the central corneal thicknesses (CCT) were 406.75 ± 16.74 µm and 340. 5 ±13.48 µm, respectively (P < 0.0001). Seven days postoperatively, the endothelial cell density (ECD) of the control group and the experimental group were 1674 ± 285/mm2 and 2561 ± 554/mm2, respectively (P < 0.05). The above differences were all statistically significant. Conclusions: This PGD based shape memory shield has a protective effect on corneal endothelium during phacoemulsification. It reduces postoperative corneal edema and ECD decrease in the short term after surgery. Translational Relevance: The shape memory PGD "shield" in this study may have a use in certain human patients with vulnerable corneas of low endothelial cell count or shallow anterior chambers.

Vitreous hyper-reflective dots and the macular thickness after cataract surgery.

PURPOSE: To assess the association between vitreous hyper-reflective dots (VHD) and the macular thickness changes following uneventful phacoemulsification. METHODS: In this prospective cohort study optical coherence tomography (OCT) examinations were performed preoperatively and 1 week, 1 month and 3 months postoperatively in patients undergoing cataract surgery. OCT images were analyzed for retinal central subfield thickness (CST) and preretinal VHDs. Surgeries were recorded for the assessment of lens fragments in the space of Berger. RESULTS: 111 eyes of 97 patient were enrolled of whom 69 (62.2%) were female. VHDs were seen in 25 eyes (22.5%) at week 1; in 21 eyes (18.9%) at month 1 and in 3 eyes (2.7%) at month 3. In all eyes with VHDs retro-capsular lens fragments were visible immediately after phacoemulsification. The number of VHDs significantly decreased over the postoperative period. There was a moderate correlation between the number of VHDs and CST at 1 month (r = 0.426, p<0.001). In eyes with VHD the CST averaged 238.8±17.6 µm (214-266) at 1 week; 276.1±63.5 µm (231-481) at 1 month and 285.1±122.3 µm (227-785) at 3 months. In eyes with no detectable VHDs CST averaged 235.9±23.3 µm (192-311) at 1 week; 240.1±21.6 µm (200-288) at 1 month and 242.2±21.3 µm (205-289) at 3 months. Although the differences among the assessment points were relatively low, there was a significant difference in general (p<0.001, Friedman test). CONCLUSION: In conclusion, VHDs seem to cause macular thickening throughout the postoperative course. The origin of VHDs is still unknown; however, they presumably represent lens fragments that provoke subclinical inflammation.

Corneal endothelial changes seven years after phacoemulsification cataract surgery.

PURPOSE: To evaluate long-term postoperative corneal changes after phacoemulsification cataract surgery. METHODS: Twenty patients who participated in a previous study regarding corneal endothelial changes after phacoemulsification cataract surgery were examined after 7 years. The patients were divided in three groups based on their initial increase in central corneal thickness day one after the surgery: < 5% increase, 6-20% increase and ≥ 20% increase. The primary outcome measures were corneal endothelial cell loss (ECL), endothelial cell count (ECC) and endothelial morphology. RESULTS: After 7 years, a difference in cell loss between the groups was observed, except for groups 1 and 2. Endothelial cell count (ECC) differed significantly between groups 1 and 3 at 3 months. At 7 years, there was no difference in ECC between the three groups. Cell loss was found exclusively in group 1 between 3 months and 7 years. Endothelial cell morphology showed a converging pattern between 3 months and 7 years. CONCLUSION: After phacoemulsification cataract surgery, long-term ECC and morphology appear to converge towards a comparable steady state regardless of initial corneal swelling and endothelial cell loss.

Visual rehabilitation after LASIK complication: flap amputation, topo-guided surgery, and phacoemulsification.

We present a case of a patient complaining of monocular diplopia due to a decentered ablation after LASIK. The patient underwent a wavefront-guided retreatment, which resulted in an epithelial ingrowth complication. Additionally, the patient developed cataract, with cataract surgery requiring reliable biometric measurements. Therefore, we opted for corneal treatment and corneal surface regularization. Although we attempted to lift the flap and wash the interface initially, the procedure proved unsuccessful, thereby necessitating immediate flap amputation. Once the corneal surface was regularized in the seventh postoperative month, transepithelial photorefractive keratectomy was successfully performed to homogenize the ocular surface, thereby significantly improving the patient's corrected visual acuity and resolving monocular diplopia. The surface and corneal curvature stabilized by the fifth month after the procedure. Phacoemulsification was then performed along with the implantation of a toric monofocal lens, which was selected using an appropriate formula, resulting in an excellent uncorrected visual acuity.

An analysis of the factors involved in IOL decentration after phacoemulsification using CASIA 2 anterior segment optical coherence tomography.

PURPOSE: To evaluate the magnitude of IOL transversal shift (ITS) after phacoemulsification and to analyse the factors contributing to IOL decentration and ITS. METHODS: 94 consecutive patients who underwent cataract surgery and IOL implantation was enrolled. Each patient underwent anterior segment optical coherence tomography with CASIA 2 (Tomey, Nagoya, Japan) to assess crystalline lens decentration, thickness and diameter seven days preoperatively and at one and sixty days postoperatively. Univariate and multivariate linear regression analysis were performed to evaluate the determinants of ITS and final decentration. RESULTS: The preoperative crystalline lens diameter was associated with the ITS and with the IOL final decentration. A positive association between the final IOL decentration and the first post-surgical day decentration was found (p < 0.0001). CONCLUSION: Greater crystalline lens diameter was associated with greater decentration and with greater ITS. Day-one IOL decentration seems to be the main determinant of final IOL decentration.

Visual outcomes and complications of combined versus sequential pars plana vitrectomy and phacoemulsification for epiretinal membrane.

BACKGROUND: Symptomatic epiretinal membrane (ERM) often requires surgical intervention via pars plana vitrectomy (PPV), for which cataract development is a common complication. There is insufficient data on the visual outcomes and complications of combined phacovitrectomy (COMB) in comparison to sequential PPV with deferred cataract surgery (SEQ) for ERM. METHODS: A retrospective dataset analysis of 8 National Health Service ophthalmology departments. The main outcome measures were postoperative visual acuity (VA), operative complications, postoperative cystoid macular oedema (CMO) and recurrent ERM. RESULTS: We included 898 and 299 eyes in the COMB and SEQ groups, respectively. Both procedures resulted in significantly better VA across all follow-up intervals (24 weeks). The proportion of eyes with Snellen VA of at least 20/40 at 12-24 weeks was comparable in both groups (47.8% [COMB] vs. 54.7% [SEQ], p = 0.4456). More eyes in the COMB group experienced posterior capsular rupture (2.9% vs. 0%, p = 0.0009) and iatrogenic retinal trauma (2.4% vs. 0%, p = 0.0023). However, regression analysis revealed that combined surgery did not predict either complication. There were no significant differences in the rates of CMO (6.5% [COMB] vs. 9% [SEQ], p = 0.1522) and recurrent ERM (2.1% [COMB] vs. 3.3% [SEQ], p = 0.2758) between both groups. CONCLUSION: Both combined and sequential procedures are comparably effective and safe means for managing eyes with ERM.

Phacoemulsification with implantation of a trifocal intraocular lens in eyes with asteroid hyalosis and synchysis scintillans.

PURPOSE: To compare the visual outcomes in both eyes of patients who undergo phacoemulsification and trifocal intraocular lens (IOL) implantation and have asteroid hyalosis (AH) or synchysis scintillans (SS) in only one eye. METHODS: A retrospective comparative case series was performed. We evaluated uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), uncorrected intermediate visual acuity (UIVA), uncorrected near visual acuity (UNVA), predictability, safety, efficacy, and satisfaction after implantation of the same model of trifocal IOL in both eyes (PhysIOL FineVision Pod-F and Micro-F and Rayner RayOne Trifocal). RESULTS: A total of 164 eyes of 82 patients (41 females, 50%) met the inclusion criteria. There were no statistically significant differences in sphere, cylinder, spherical equivalent, UDVA, UIVA, or UNVA between the groups. Postoperative CDVA was slightly better in the control group (logMAR 0.03) than in the AH/SS group (logMAR 0.04) (P: 0.014). There were no statistically significant differences in predictability, safety index, or efficacy index between the groups. Overall subjective satisfaction was good (98.2%). CONCLUSIONS: Visual outcomes and satisfaction are good after implantation of trifocal IOLs in eyes with AH or SS. Therefore, trifocal IOLs should not be ruled out in these patients when no other vitreoretinal disorder is present.

Narrative review after post-hoc trial analysis of factors that predict corneal endothelial cell loss after phacoemulsification: Tips for improving cataract surgery research.

PURPOSE: Identifying pre/perioperative factors that predict corneal endothelial-cell loss (ECL) after phacoemulsification may reveal ways to reduce ECL. Our literature analysis showed that 37 studies have investigated one or several such factors but all have significant limitations. Therefore, the data of a large randomized controlled trial (PERCEPOLIS) were subjected to post-hoc multivariate analysis determining the ability of nine pre/perioperative variables to predict ECL. METHODS: PERCEPOLIS was conducted in 2015-2016 to compare two phacoemulsification techniques (subluxation and divide-and-conquer) in terms of 3-month ECL. Non-inferiority between the techniques was found. In the present study, post-hoc univariate and multivariate analyses were conducted to determine associations between ECL and age, sex, cataract density, preoperative endothelial-cell density, phacoemulsification technique, effective phaco time (EPT), and 2-hour central-corneal thickness. The data are presented in the context of a narrative review of the literature. RESULTS: Three-month data were available for 275 patients (94% of the randomized cohort; mean age, 74 years; 58% women). Mean LOCSIII cataract grade was 3.2. Mean EPT was 6 seconds. Mean ECL was 13%. Only an older age (beta = 0.2%, p = 0.049) and higher EPT (beta = 1.2%, p = 0.0002) predicted 3-month ECL. Cataract density was significant on univariate (p = 0.04) but not multivariate analysis. The other variables did not associate with ECL. CONCLUSIONS: Older age may amplify ECL due to increased endothelial cell fragility. EPT may promote ECL via cataract density-dependent and -independent mechanisms that should be considered in future phacoemulsification research aiming to reduce ECL. Our literature analysis showed that the average ECL for relatively unselected consecutively-sampled cohorts is 12%.

Effectiveness and safety of XEN63 in patients with primary-open-angle glaucoma.

This paper evaluates the effectiveness and safety of XEN63 stent, either standalone or in combination with phacoemulsification, in patients with primary open-angle glaucoma (POAG). Eighty eyes from 80 patients with medically uncontrolled POAG were assigned to undergo XEN63 implant. The primary outcome was the surgical success, defined as an intraocular pressure (IOP) lowering from preoperative values ≥ 20% and an IOP absolute value between 6 and 18 mmHg, with or without antiglaucoma medications. Forty-three (53.7%) eyes underwent XEN63-standalone and 37(46.2%) eyes a XEN63 + Phacoemulsification procedure. Success rate was 68.8% (55/80) eyes in the overall study sample, 69.8% (30/43) eyes in the XEN63-standalone group; and 67.6% (25/37) eyes in the XEN63 + Phaco group (p = 0.6133). Preoperative IOP was significantly lowered from 22.1 ± 4.9 mmHg and 19.8 ± 3.7 mmHg to 14.7 ± 5.3 mmHg and 13.8 ± 3.4 mmHg in the XEN63-standalone and XEN63 + Phaco groups, respectively (p < 0.0001 each, respectively); without significant differences between them at any of the time-points measured. Preoperative number of ocular-hypotensive drugs was significantly reduced from 2.3 ± 0.8 to 0.3 ± 0.7 drugs, from 2.5 ± 0.7 to 0.3 ± 0.7 drugs; and from 2.0 ± 0.8 to 0.3 ± 0.7 drugs, in the overall, XEN63-standalone, and XEN63 + Phaco groups, respectively. Regarding safety, 3(42.5%) eyes had transient hypotony at some point during the study, although only in one (1.2%) eye was clinically significant. Four (5.0%) eyes underwent a needling, 4 (5.0%) eyes underwent surgical-bleb-revision, 1 (1.2%) eye required a device replacement and 1 (1.2%) eye a device removal due to maculopathy. XEN63, either alone or in combination with phacoemulsification, significantly lowered IOP and reduced the number of ocular hypotensive medications. The rate of ocular hypotony was relatively high, although it was clinically relevant only in one eye.

Statistical analysis plan for the phaco TIp position during clear corneal Phacoemulsification Surgery (TIPS) randomized controlled trial.

BACKGROUND: Cornea is the most important refractive media in the eye, and damage to the corneal endothelium is one of the most common causes of poor visual outcome following cataract surgery, particularly in those with predisposing factors. The role of phaco tip position during phacoemulsification on corneal endothelial damage is ambiguous, and there is no consensus regarding the most cornea-friendly phaco tip position (bevel-up or bevel-down). The objective of the trial is to compare the effect of phaco tip position (bevel-up vs. bevel-down) during phacoemulsification using direct chop technique on corneal endothelial cell count. METHODS AND DESIGN: TIPS is a randomised, multicentre, parallel-group, triple-masked (participant, outcome assessor, and statistician) trial with 1:1 allocation ratio. A total of 480 eligible participants, aged > 18 years with immature cataract, will be randomly allocated into bevel-up and bevel-down groups at two centres. Randomisation will be stratified according to the cataract grade. The primary outcome is postoperative endothelial cell count at 1 month. Secondary outcomes are central corneal thickness on postoperative days 1, 15, and 30 and difference in intraoperative complications. CONCLUSION: In this paper, we describe the detailed statistical analysis plan (SAP) for the TIPS trial, which was prepared prior to database lock. The SAP includes details of planned analyses and unpopulated tables, which will be reported in the publications. We plan to lock the database in July 2023 and publish the results later in the same year. SAP Version 0.1 (dated: 28 April 2023) Protocol version:2.0 TRIAL REGISTRATION: Clinical Trial Registry of India CTRI/2019/02/017464. Registered on 5 February 2019; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=29764&EncHid=&userName=2019/02/017464.

Late spontaneous posterior capsule rupture with single-piece hydrophobic acrylic intraocular lens dislocation.

In this study, we described and discussed the late onset spontaneous posterior capsule rupture with intraocular lens (IOL) dislocation years after uncomplicated cataract surgery and implantation of hydrophobic acrylic IOLs. Eight patients presented with spontaneous posterior capsule rupture and IOL dislocation 5-20 years after uncomplicated phacoemulsification and IOL (AcrySof, Alcon, US) implantation. None of the patients had undergone posterior capsulotomy in the past. Four of the patients admitted habitual eye rubbing. An intact and well-centered continuous curvilinear capsulotomy edge was observed in all cases. IOLs were dislocated or displaced behind the anterior capsulotomy with a significant decrease in vision. A large rupture with a curled edge of the broken posterior capsule was visible. Dislocated IOLs were removed, and a three-piece IOL was inserted in the sulcus in six cases and suture fixated to the sclera in two cases. Improved vision was achieved in all cases. Although the mechanism underlying this late complication is unclear, habitual eye rubbing or IOL design may play a role. Further investigation is needed to prevent this complication in the future.