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.

Safety of intracameral application of moxifloxacin and dexamethasone (Vigadexa®) after phacoemulsification surgery.

BACKGROUND: Intracameral antibiotics, such as moxifloxacin and cefuroxime, are safe to corneal endothelial cells and effective prophylaxis of endophthalmitis after cataract surgery. Corneal endothelial cells decrease in density after cataract surgery. Any substance used in the anterior chamber may affect corneal endothelial cells and lead to a greater decrease in density. This study wants to determine the percentage of endothelial cell loss after cataract extraction by phacoemulsification with off-label intracameral injection of moxifloxacin and dexamethasone (Vigadexa®). METHODS: An observational retrospective study was performed. The clinical records of patients undergoing cataract surgery by phacoemulsification plus intracameral injection of Vigadexa® were analyzed. Endothelial cell loss (ECL) was calculated using preoperative and postoperative endothelial cell density. The relation of endothelial cell loss with cataract grade using LOCS III classification, total surgery time, total ultrasound time, total longitudinal power time, total torsional amplitude time, total aspiration time, estimated fluid usage, and cumulative dissipated energy (CDE) was studied using univariate linear regression analysis and logistic regression analysis. RESULTS: The median loss of corneal endothelial cells was 4.6%, interquartile range 0 to 10.4%. Nuclear color and CDE were associated with increased ECL. ECL>10% was associated with age and total ultrasound time in seconds. CONCLUSIONS: The endothelial cell loss after the intracameral use of Vigadexa® at the end of cataract surgery was similar to the reported in other studies of cataract surgery without the use of intracameral prophylaxis for postoperative endophthalmitis (POE). This study confirmed the association of CDE and nuclear opalescence grade with postoperative corneal endothelial cell loss.

Mechanical protective effect of lens anterior capsule disc on corneal endothelial cells during femtosecond laser-assisted cataract surgery in a rabbit model.

PURPOSE: To evaluate the effects of a novel technique using an isolated lens anterior capsule disc (LACD) to protect corneal endothelial cells in rabbit eyes during femtosecond laser-assisted cataract surgery. METHODS: Experimental study. 40 rabbits were divided into endothelium-protected (experimental) and control groups, with 20 rabbits in each group. In the experimental group, after femtosecond laser capsulotomy, the isolated capsule disc was lifted to the corneal endothelium by an ophthalmic viscosurgical device. The endothelium was damaged for 1 min with an ultrasonic probe. The control group underwent the same surgery, except that the disc was removed immediately after capsulorhexis. Corneal endothelioscopy was performed preoperatively and on postoperative days (PODs) 3 and 7 to observe endothelial cell counts (ECC) and endothelial cell loss rate. Central corneal thickness (CCT) was measured before and at PODs 1, 3 and 7. RESULTS: There were 3.59%±1.88% (p < 0.001) and 2.92%±2.14% (p < 0.001) loss of ECC in experimental group at POD3 and POD7, respectively, while those in the control group were 11.62%±7.43% and 10.34%±5.77%, respectively. On POD 1, the difference in central corneal thickness was significant(P = 0.019) between the two groups. At POD 3 and POD 7, CCT was not significantly different (P = 0.597;0.913) between the two groups. CONCLUSIONS: The isolated LACD technique significantly reduced damage to the endothelium caused by ultrasonic energy and protects corneal endothelial cells during phacoemulsification.

Femtosecond laser semi-assisted Descemet stripping endothelial keratoplasty: 2-year outcomes of endothelial cell loss and graft survival.

PURPOSE: To assess 2-year endothelial cell loss and graft survival after femtosecond laser semi-assisted Descemet stripping endothelial keratoplasty (FLS-DSEK). METHODS: In this prospective and noncomparative study carried out at Eye Hospital of Shandong First Medical University, 85 eyes (84 patients) with endothelial dysfunction receiving FLS-DSEK (n=62, 75.9%) or FLS-DSEK combined with phacoemulsification cataract surgery and intraocular lens implantation (n=23, 27.1%) from 2013 through 2016 were included. The graft endothelial cell loss, endothelial graft thickness, visual acuity, and complications after surgery were evaluated. RESULTS: Thin endothelial grafts were all successfully prepared, with no occurrence of perforation. The rate of endothelial cell loss was 17.4%, 18.8%, 19.9%, and 26.7%, and the central graft thickness was 113±54 µm, 102±40 µm, 101±28 µm, and 96±23 µm at 3, 6, 12, and 24 months, respectively. The median best-corrected visual acuity was 0.4 logMAR (range, 0-2 logMAR) at 24 months, demonstrating a significant difference from that before surgery (2 logMAR; range, 0.2-3 logMAR) (T=187.5, P<.001). Partial graft dislocation was the most common postoperative complication, with an occurrence rate of 14% (n=12), and it was associated with an abnormal iris-lens diaphragm (r=.35, P<.001). The other complications included a high intraocular pressure (n=5, 6%), endothelial graft rejection (n=4, 5%), and pupillary block (n=1, 1%). Endothelial graft decompensation occurred in the two eyes, and 98% (n=83) of the grafts survived at 24 months. CONCLUSIONS: Data of the study suggest that the treatment using FLS-DSEK seems to be promising and might be considered a feasible choice in patients with endothelial dysfunction. TRIAL REGISTRATION: 1. Date of registration: 2021-02-18 2. TRIAL REGISTRATION NUMBER: ChiCTR2100044091 3. Registration site: https://www.chictr.org.cn/.

Effect of Six-Month Postoperative Endothelial Cell Density on Graft Survival after Descemet Membrane Endothelial Keratoplasty.

PURPOSE: To analyze if 6-month endothelial cell density (ECD) affects long-term ECD outcome and graft survival 5 years after Descemet membrane endothelial keratoplasty (DMEK) in eyes with Fuchs endothelial corneal dystrophy (FECD). DESIGN: Retrospective cohort study. PARTICIPANTS: A total of 585 DMEK eyes were included. The study group was divided into 4 groups based on 6-month ECD quartiles: group 1 (n = 146) with 313 to 1245 cells/mm2, group 2 (n = 148) with 1246 to 1610 cells/mm2, group 3 (n = 145) with 1611 to 1938 cells/mm2, and group 4 (n = 146) with 1939 to 2760 cells/mm2. Group 1 was further split into subgroups 1a (n = 36) with 6-month ECD of ≤828 cells/mm2, 1b (n = 37) with 829 to 1023 cells/mm2, 1c (n = 37) with 1024 to 1140 cells/mm2, and 1d (n = 36) 1141 to 1245 cells/mm2. METHODS: Descemet membrane endothelial keratoplasty. MAIN OUTCOME MEASURES: Long-term ECD, graft survival, and postoperative complication rates. RESULTS: For group 1, 6-month ECD decreased from 951 (±233) cells/mm2 (n = 146) to 735 (±216) cells/mm2 (n = 99) at 5 years postoperatively. Group 1 graft survival probability was 0.95 (95% confidence interval [CI], 0.91-0.99] at 5 years postoperatively, which was lower than for groups 2 to 4 (P = 0.001). Five-year graft survival in subgroup 1a was 0.79 (95% CI, 0.67-0.94), which was lower than in subgroups 1b to 1d (P = 0.001). Preoperative ECD did not influence graft survival (P = 0.400), and higher 6-month ECD values were associated with lower graft failure rates (hazard ratio, 0.994; 95% CI, 0.99-1.00; P = 0.001). CONCLUSIONS: Six-month ECD is associated with DMEK graft survival. High early cell loss after DMEK negatively affects long-term ECD outcome and graft survival. Grafts in the lowest 6-month ECD subgroup (≤828 cells/mm2) are at higher risk of failure within 5 years after DMEK. To ensure sufficiently high 6-month ECD, preoperative graft quality assessment should be optimized, and cellular stress induced to the graft should be minimized. Additionally, developing therapeutic options for the treatment of low postoperative ECD could further improve DMEK graft longevity.

The effects of trypan blue use on the corneal endothelium during cataract surgery in patients with pseudoexfoliation syndrome (PEX).

PURPOSE: In the present clinical study, it was aimed to investigate the possible effects of Trypan blue (TB) use on the corneal endothelium during cataract surgery in eyes with pseudoexfoliation syndrome (PEX) during a three-month follow-up period using the contralateral eye control design. METHODS: This prospective, randomised controlled, individual cohort study included 92 eyes of 46 patients with bilateral PEX and cataracts. While 1% TB was applied to one eye of the patients before capsulorhexis (study group), it was not applied to the other eye (control group). Both groups were compared preoperatively and postoperatively in terms of endothelial cell density (ECD), endothelial cell loss (%), pleomorphism, polymegathism and central corneal thickness (CCT) using specular microscopy. RESULTS: Preoperative corneal ECD was measured as 2362.56 ± 253.27 in the study group, 2380.84 ± 220.54 in the control group, and 2145.58 ± 221.71 in the study group and 2184.97 ± 200.94 cells/mm2 in the control group in the postoperative 3rd-month follow-up (p = 0.71 and = 0.37, respectively). In addition, there were no significant differences between the two groups in terms of the percentage of hexagonal cells, coefficient of variation (CV), and CCT both preoperatively and postoperatively 3 months later (p = 0.78, =0.39, =0.95 preoperatively and p = 0.31, =0.26, =0.83 postoperatively, respectively). CONCLUSION: This study demonstrated that the injection of 1% TB into the anterior chamber for staining the anterior capsule during cataract surgery did not cause significant corneal endothelial changes at postoperative 3rd months, despite the increased fragility of corneal endothelial cells in patients with PEX.

Efficacy and safety of iris-supported phakic lenses (Verisyse) for the treatment of high myopia: 5-year results.

PURPOSE: Evaluating efficacy and safety of iris-supported phakic lenses (Verisyse) for high myopia treatment. METHODS: Patients treated with Verisyse (Abbott Medical Optics, Santa Ana, CA, USA) intraocular lens (IOL) implants were evaluated retrospectively. Patients with follow-up periods of more than 5 years were included in the study. Pre- and postoperative fifth-year spheric equivalent (SE) of manifest refraction values, uncorrected and corrected distance visual acuities (UDVA and CDVA, respectively), and endothelial cell density (ECD) values were recorded. Complications were evaluated. RESULTS: Forty-seven eyes of 31 patients were included in the study. Pre- and postoperative fifth year mean SE was - 12.50 ± 3.51D and - 0.72 ± 0.40D, respectively. Pre- and postoperative fifth-year UDVA was 1.56 ± 0.22 and 0.33 ± 0.18 logMAR (p < 0.001), respectively. The safety index (pre- and postoperative CDVA) was 1.39 ± 0.63 at the 5-year follow-up (p > 0,05). The efficacy index (ratio of mean postoperative UDVA to mean preoperative CDVA) of the patients was 1.14 ± 0.60. The mean postoperative endothelial cell loss at 5 years was -7.42%. None of the patients had lost 25% of their preoperative endothelial cells at 5-year follow-up. The mean postoperative endothelial cell loss was -3.05% at 1 year, -1.23% between years one and three, -1.02% between the third and fifth years. CONCLUSION: Verisyse IOL implantation is an effective and safe for high myopia surgical treatment. However, the 5-year follow-up period is not sufficient to evaluate the safety profiles in terms of endothelial cells.

Safety and efficacy of hypertonic saline solution (5%) versus placebo in the treatment of postoperative corneal edema after uneventful phacoemulsification: a randomized double-blind study.

PURPOSE: To evaluate safety and efficacy of hypertonic saline solution administration after uneventful cataract surgery. DESIGN: Prospective double-blind randomized study METHODS: In total, 183 eyes of 183 patients undergoing phacoemulsification were randomly allocated into two equal groups. Treatment group (TG) subjects received single-dose hypertonic (NaCl 5%) solution 4 times daily for 14 days, while placebo group (PG) received single dose of normal saline solution (0.9%) at the same frequency in addition to ordinary postoperative treatment. All patients underwent assessment of central corneal thickness (CCT), endothelial cell density (ECD), best-corrected visual acuity (BCVA), clinical staging of postoperative corneal edema and questionnaire regarding the procedure success and impact on patient's life. Measurements were taken at baseline and 1, 4, 9 and 30 days following surgery. RESULTS: CCT increased by 134.67 ± 94.51 µm (25.1 ± 19.4%) on postoperative day 1, without any difference between study groups (p = 0.58). Corneal edema showed a significant recession in TG compared to PG on day 4, in terms of both pachymetry (10.73% vs 7.39%, p = 0.004), BCVA (BCVATG = 0.64 ± 0.24 [logMARTG = 0.25 ± 0.3], BCVAPG = 0.56 ± 0.23 [logMARPG = 0.33 ± 0.3], p = 0.04) and clinical staging (p = 0.02). Similar results were recorded on postoperative day 9 in subjects demonstrating marked corneal edema on the first postoperative day. Endothelial cell loss showed no statistically significant difference between study groups (p = 0.48). No adverse events were recorded in relation to treatment. More patients in the TG (92.4% vs 57.1% in the PG) reported a subjectively clear vision 1 week postoperatively (p = 0.04). CONCLUSION: The use of 5% hypertonic saline solution is found to be a safe and effective adjunct in the management of postoperative corneal edema after uneventful phacoemulsification, achieving rapid corneal clearance and expediting a good visual outcome, especially in cases with marked postoperative edema.

[Efficacy of double-incision extracapsular cataract extraction in the treatment of hard-nucleus cataract with low corneal endothelial cell density].

Objective: To discuss the efficacy and security of double-incision extracapsular cataract extraction (ECCE) in the treatment of hard-nucleus cataract with low corneal endothelial cell density. Methods: This was a retrospective case series study. Forty-six patients (47 eyes) with hard-nucleus cataract and low corneal endothelial cell density were enrolled at Shandong Eye Hospital from June 2009 to December 2018, including 22 males and 24 females, aged 50 to 74 (63.8±6.3) years. Preoperative corneal endothelial cell density was less than 1 000 cells/mm(2), and the cataract nuclear hardness was equal to or greater than grade IV. According to the surgical methods, the patients were divided into the single-incision ECCE group (24 eyes) and the double-incision ECCE group (23 eyes). The surgical procedures for the double-incision group were as follows. First, a superior scleral pre-incision was made. Then the conventional capsulorhexis was conducted through a 2.6 mm transparent corneal tunnel incision at the temporal or the nasal side, after which the hydro-dissection was performed. Next, the surgeon cut the pre-incision at the sclera, delivered the lens nucleus, sutured the scleral incision and removed the residual cortical materials from the corneal incision. Finally, a foldable intraocular lens was implanted, and the viscoelastic substance was removed. The intraoperative anterior chamber condition and the postoperative corneal edema condition were monitored. During the 6 month follow-up after surgeries, the endothelium cell density, visual acuity and astigmatism in the two groups were compared. The χ(2) test was used to compare the counting data, and the t test was used to compare the measurement data. Results: There was no statistically significant difference (t=1.12, P=0.28) in the preoperative corneal endothelial cell density between the double-incision and single-incision ECCE groups, which was (827±164) cells/mm(2) and (802±121) cells/mm(2), respectively. At 6 months after operation, in the double-incision and single-incision groups, the endothelial cell density was (793±147) cells/mm(2) and (706±101) cells/mm(2), respectively, and the difference was statistically significant (t=4.37, P<0.01). The percentage of corneal endothelial cell loss was 4.16%±3.12% and 11.69%±2.96%, respectively, and the difference was also statistically significant (t=9.52, P<0.01). The hexagon loss rate of corneal endothelial cells was 9.67%±6.11% and 28.33%±8.39%, respectively, and the difference was statistically significant (t=5.52, P<0.05). In the follow-up of 6 months, none of the eyes in the double-incision ECCE group suffered corneal endothelial decompensation compared with 3 eyes in the single-incision ECCE group. There were no statistically significant differences in postoperative astigmatism and surgically induced astigmatism between the two groups (t=-0.71, 0.15; P>0.05). Conclusions: The double-incision ECCE, in which the lens nucleus is delivered through a scleral incision and other procedures are conducted through a corneal tunnel incision, is safe and effective for cataract patients with hard nucleus and low corneal endothelial cell density. (Chin J Ophthalmol, 2020, 56: 126-130).

Long-term endothelial cell loss with the iris-claw intraocular phakic lenses (Artisan®).

PURPOSE: To evaluate the endothelial cell loss in patients with iris-claw phakic lenses (Artisan®) in a long-term follow-up. METHODS: We analyzed the medical records of patients who had undergone iris-claw phakic lens implantation and who had at least 5 years of follow-up. RESULTS: We included 67 eyes with myopic errors (follow-up 9.6 ± 3.0 years) and 10 eyes with mixed astigmatism or hyperopic errors (follow-up 8.8 ± 2.5 years). The mean total endothelial density loss at the last follow-up visit was 18.5% ± 17.0% and 10.5% ± 12.3%, respectively. 29.9% of the eyes in the myopic group and 20% in the hyperopic group lost more than 25% of the preoperative endothelial cell density. During the postoperative follow-up period, 60.8% of the eyes in the myopic group and 40% of the eyes in the hyperopic group lost a higher percentage than the expected physiological loss. Two eyes in the myopic group (3.0%) had a final cell density of less than 1200 cells/mm2. None of the variables studied had a statistically significant association with the percentage of annual endothelial loss in the postoperative period. Three phakic lenses were explanted: two by cataract and one by cataract and severe decrease of the endothelial density (862 cells/mm2). CONCLUSIONS: There is a significant endothelial cell loss in a low percentage of the eyes with Artisan® lenses in the long term, and it can decrease to critical levels. Periodic endothelial density evaluations are required for these patients. The selection criteria of surgical candidates could be reevaluated.

Vulnerability of corneal endothelial cells to mechanical trauma from indentation forces assessed using contact mechanics and fluorescence microscopy.

Corneal endothelial cell (CEC) loss occurs from tissue manipulation during anterior segment surgery and corneal transplantation as well as from contact with synthetic materials like intraocular lenses and tube shunts. While several studies have quantified CEC loss for specific surgical steps, the vulnerability of CECs to isolated, controllable and measurable mechanical forces has not been assessed previously. The purpose of this study was to develop an experimental testing platform where the susceptibility of CECs to controlled mechanical trauma could be measured. The corneal endothelial surfaces of freshly dissected porcine corneas were subjected to a range of indentation forces via a spherical stainless steel bead. A cell viability assay in combination with high-resolution fluorescence microscopy was used to visualize and quantify injured/dead CEC densities before and after mechanical loading. In specimens subjected to an indentation force of 9 mN, the mean ±â€¯SD peak contact pressure P0 was 18.64 ±â€¯3.59 kPa (139.81 ±â€¯26.93 mmHg) in the center of indentation and decreased radially outward. Injured/dead CEC densities were significantly greater (p ≤ 0.001) after mechanical indentation of 9 mN (167 ±â€¯97 cells/mm2) compared to before indentation (39 ±â€¯52 cells/mm2) and compared to the sham group (34 ±â€¯31 cells/mm2). In specimens subjected to "contact only" - defined as an applied indentation force of 0.65 mN - the peak contact pressure P0 was 7.31 ±â€¯1.5 kPa (54.83 ±â€¯11.25 mmHg). In regions where the contact pressures was below 78% of P0 (<5.7 kPa or 42.75 mmHg), injured/dead CEC densities were within the range of CEC loss observed in the sham group, suggesting negligible cell death. These findings indicate that CECs are highly susceptible to mechanical trauma via indentation, supporting the established "no-touch" policy for ophthalmological procedures. While CECs can potentially remain viable below contact pressures of 5.7 kPa (42.75 mmHg), this low threshold suggests that prevention of indentation-associated CEC loss may be challenging.

[The changes and influencing factors of corneal endothelial cell density after endothelial keratoplasty].

Endothelial keratoplasty is a surgery that selectively replaces the diseased endothelium and reserves the normal corneal epithelial and stromal layers. It is now gradually replacing penetrating keratoplasty in treating endothelial dysfunction. Although endothelial cell loss exists after endothelial keratoplasty, the number of lost cells is obviously less than that of penetrating keratoplasty. The amount and function of corneal endothelial cells are important factors for maintaining corneal transparency and indicating the survival of the graft. Thus, the changes of corneal endothelial cell density after surgery are significant in predicting the prognosis. This article elaborates on the changes of endothelial cell density after endothelial keratoplasty and related influencing factors, aiming to provide reference and basis for clinical diagnosis and treatment. (Chin J Ophthalmol, 2018, 54:954-960).

Clinical outcomes of trabeculectomy vs. Ahmed glaucoma valve implantation in patients with penetrating keratoplasty : (Trabeculectomy vs. Ahmed galucoma valve in patients with penetrating keratoplasty).

The aim of this study was to compare the visual outcomes, intraocular pressure (IOP), and endothelial cell loss caused by trabeculectomy (TRAB) and Ahmed glaucoma valve (AGV) implantation in patients who had previously undergone penetrating keratoplasty (PKP). The data from all patients who underwent surgical treatment of glaucoma after PKP were reviewed at the Cornea Department of Haydarpasa Numune Education and Research Hospital. Eighteen patients who had undergone surgical treatment of glaucoma after PKP were included in this retrospective study. Time between PKP and glaucoma surgeries, visual acuity results, IOP results, endothelial cell counts (ECC) before the surgery, at 1st, 6th, and 12th month of surgery were recorded. Differences between two groups were evaluated. Mean loss of ECC was 315 cells/mm(2) in the AGV group and 197 cells/mm(2) in TRAB group at 12th month of glaucoma surgery. The difference between endothelial cell loss at 12th month of surgery was statistically significant and higher in AGV group (p < 0.001). The decrease in IOP was 64.2 % in AGV group and 46.9 % in TRAB group at 12th month of surgery. Both differences were statistically significant between 2 groups (p = 0.001, 0.001). TRAB successfully decreased both the IOP and endothelial cell loss in patients with post-PKP glaucoma. Ahmed glaucoma valve had a significantly better IOP lowering but higher endothelial cell loss effect.

Late-onset corneal edema after customized crosslinking for progressive keratoconus.

Purpose: We describe a patient after customized crosslinking (CXL) for progressive keratoconus who developed corneal edema with spontaneous resolution. Observations: A 24-year-old male with progressive keratoconus of the left eye underwent a customized CXL procedure with a total energy of 10 J/cm2 for 16.4 minutes. Preoperative corrected distance visual acuity (CDVA) was 20/30 with a maximum keratometry (K)-value of 58.6 diopter (D) and the thinnest point measured 414 µm. The preoperative endothelial cell density (ECD) was 2414 cells/mm2. During treatment, corneal thickness was 325 µm after epithelial debridement and 375 µm after the application of 0.1 % riboflavin containing HPMC. After the treatment, antibiotic and steroid drops were prescribed for 5 days and 3 weeks, respectively. At the 1-month post-CXL visit the patient had no complaints, visual acuity and clinical examination showed no irregularities. At the 4-months post-CXL visit the patient complained of blurry vision. The CDVA was 20/100 and slit-lamp examination showed microcystic corneal edema. The corneal thickness at the thinnest point measured 440 µm. One month later the edema had resolved spontaneously and CDVA had restored to 20/25. Corneal thickness at the thinnest point measured 415 µm, the ECD was 1514 cells/mm2 and confocal microscopy showed normal structural changes in the anterior stroma after CXL, with the demarcation line located at a depth of 414 µm, just above the corneal endothelium. Conclusions and importance: We report a case of corneal edema following customized CXL with endothelial cell loss that resolved spontaneously. We recommend either adhering to a minimal stromal thickness of 400 µm before administering UV-A irradiation, using a contact lens or adjusting the irradiation to prevent this complication.

Predicting Long-Term Endothelial Cell Loss after Preloaded Descemet Membrane Endothelial Keratoplasty in Fuchs' Endothelial Corneal Dystrophy: A Mathematical Model.

(1) Background: This study offers a biexponential model to estimate corneal endothelial cell decay (ECD) following preloaded "endothelium-in" Descemet membrane endothelial keratoplasty (DMEK) in Fuchs' endothelial corneal dystrophy (FECD) patients; (2) Methods: A total of 65 eyes undergoing DMEK alone or combined with cataract surgery were evaluated. The follow-up period was divided into an early phase (first 6 months) and a late phase (up to 36 months). Endothelial cell count (ECC) and endothelial cell loss (ECL) were analyzed; (3) Results: The half time of the ECD was 3.03 months for the early phase and 131.50 months for the late phase. The predicted time-lapse interval to reach 500 cells/mm2 was 218 months (18.17 years), while the time-lapse interval to reach 250 cells/mm2 was 349 months (29.08 years). There was no statistically significant difference between the ECL in DMEK combined with cataract extraction and DMEK alone at 24 months (p ≥ 0.20). At the late phase, long-term ECL prediction revealed a lower ECC half time in patients undergoing DMEK combined with cataract surgery (98.05 months) than DMEK alone (250.32 months); (4) Conclusions: Based on the mathematical modeling, a predicted average half-life of a DMEK graft could reach 18 years in FECD. Moreover, combining cataract extraction with DMEK could result in excessive ECL in the long term.

Retropupillary Iris-fixated versus Sutured Scleral-fixated Intraocular Lenses.

Aim: To compare the anatomical and functional results and patient satisfaction following retropupillary implantation of Artisan Aphakia iris-fixated intraocular lens (rAAIF) and sutured scleral fixated intraocular lens (SFIOL). Subjects and methods: We presented a prospective double-arm non-blinded study. Forty-one eyes with acquired aphakia, no age-related macular degeneration, no previous keratoplasty, no combined procedures, no AC reaction (cells, fibrin), normal intraocular pressure, no history of endothelial corneal dystrophy in relatives or fellow eye were included. Indications, complications, corrected distance visual acuity (CDVA), endothelial cell density (ECD), and patient satisfaction score were assessed. Results: Retropupillary AAIF was implanted in 21 (51.22%) eyes and SFIOL in 20 (48.78%) eyes. The most common indication was complicated cataract surgery in 18 cases (43.90%), followed by trauma in 16 (39.02%), and spontaneous dislocation in 7 (17.07%). No difference between rAAIF and SFIOL in terms of sex, laterality (χ=0.13, p=0.72), indications (χ=0.78, p=0.68), previous ocular history, and comorbidities was observed. The complications and the visual outcomes at 6 months postoperatively were similar between the two groups (p=0.95 and p=0.321, respectively). The ECD loss in the two groups was also similar (p=0.89). The patient satisfaction score was 58.67±8.80 in the rAAIF and 56.69±11.50 in the SFIOL group, which was statistically similar (p=0.764). Conclusion: Retropupillary AAIF and SFIOL showed similar results concerning visual acuity, endothelial cell loss, and patient satisfaction. Careful preoperative individual assessment is required to have optimal results with either technique. Abbreviations: AAIF = Artisan Aphakia iris-fixated intraocular lens, rAAIF = retropupillary Artisan Aphakia iris-fixated intraocular lens, CDVA = corrected distance visual acuity, ECD = endothelial cell density, IOL = intraocular lens, SD = standard deviation, SFIOL = scleral fixated intraocular lens.

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.

DMEK Surgery at a Tertiary Hospital in Sweden. Results and Complication Risks.

Purpose: This study reports clinical outcomes up to 6 years after Descemet's membrane endothelial keratoplasty (DMEK) performed at the Department of Ophthalmology, Örebro University Hospital, Örebro, Sweden. Methods: The study has a cross-sectional and case series design. Inclusion criteria were all DMEK-operated eyes during 2013-2018 until repeat keratoplasty. Results: Altogether 162 eyes from 120 patients were enrolled. Among eyes without preoperative comorbidities, examined 1-6 years after DMEK, 85.8% achieved visual acuity of 0.1 logMAR or better. The median endothelial cell density (ECD) loss was 27% in a cohort of eyes examined 1-2 years post-DMEK, 31% at 2-3 years, 42% at 3-4 years, and > 60% at 4-6 years post-DMEK. ECD at the examination timepoint was correlated with donor ECD (as expected) and time since surgery. Conclusion: The results from DMEK surgeries in Örebro, Sweden, are promising. Further studies with even longer follow-up are needed to evaluate graft sustainability.

Characteristics of the low density corneal endothelial monolayer.

Corneal endothelial cells form a leaky barrier on the posterior surface of the cornea, allowing influx of nutrient-carrying aqueous humor through the paracellular space and efflux of excess fluid. Corneal edema arises when the density of these non-proliferative endothelial cells declines from endothelial disease or intraocular surgery. The cellular changes occurring at low densities are ill-defined. We therefore investigated the paracellular pathway of corneal endothelial cell monolayers of varying density to determine alterations occurring in paracellular permeability and monolayer morphology. Primary cultures of bovine corneal endothelial cells (BCECs) were passaged onto permeable supports under varying culture conditions to obtain confluent monolayers of <1000, 1000-1999 and >2000 cells/mm(2). Culture growth was monitored by transendothelial electrical resistance measurements. Diffusional permeability to sodium fluorescein, FITC-dextran MW 4000 or FITC-dextran MW 20,000 was measured. Confluent cultures were also analyzed by immunofluorescence localization of the tight junction protein ZO-1 and by transmission electron microscopy. For comparison, we evaluated ZO-1 for low and high density human corneal endothelium. Our results showed that all BCEC cultures grew to the same final transendothelial electrical resistance regardless of final density. In the diffusional permeability assay, permeability increased significantly only for the smallest tracer molecule (sodium fluorescein) in the lowest density monolayers (<1000 cells/mm(2)). ZO-1 immunofluorescence distinctly localized to intercellular junctions in high density BCEC cultures but had more diffuse localization at lower densities. Transmission electron microscopy imaging revealed cells with thinner cross-sectional profiles and longer overlapping intercellular processes at low density relative to high density cultures. Low density human corneal endothelium lacked the diffuse ZO-1 distribution seen in BCECs. Our data supports the hypothesis that barrier integrity is the primary function disrupted in low density corneal endothelial monolayers and contradicts the idea of a linear decline in barrier function with decreasing cell density.

Long-Term Surgical Outcomes and Possible Postoperative Complication with Severe Corneal Endothelial Cell Loss After Trabeculectomy for Cytomegalovirus-Associated Anterior Uveitis with Secondary Glaucoma.

PURPOSE: We assess long-term surgical outcomes after an initial trabeculectomy for cytomegalovirus-associated anterior uveitis with secondary glaucoma (CMV-SG). METHODS: We retrospectively reviewed the medical records of 16 eyes of 15 patients with CMV-SG and 157 eyes of 157 patients with primary open-angle glaucoma. The average follow-up period was approximately 3 years. Surgical success was defined as intraocular pressure (IOP) below 18 mmHg and at least 20% lower than baseline. RESULTS: Kaplan-Meier survival analysis revealed that bleb survival rates were not significantly different in the CMV-SG and POAG groups (P = 0.75). Bullous keratopathy occurred in 2 of 16 eyes with CMV-SG postoperatively but did not occur in the POAG group. The corneal endothelial cell density decreased by 34.2 ± 22.7% in the CMV-SG group during an average follow-up period of 2.7 ± 2.0 years. CONCLUSION: Trabeculectomy effectively controlled IOP in CMV-SG, but attention must be paid to corneal endothelial cell loss.