Dataset Information

Corneal Endothelial Cell Changes After Phacoemulsification Combined with Excisional Goniotomy with the Kahook Dual Blade or iStent: A Prospective Fellow-Eye Comparison.

ABSTRACT: Purpose: To characterize changes in endothelial cell density and morphology following phacoemulsification combined with either excisional goniotomy with the Kahook Dual Blade (KDB-phaco) or first-generation iStent trabecular microbypass implantation (iStent-phaco).

Setting: A single clinical practice.

Methods: Twenty-one adult subjects from one center with visually significant cataract and mild-moderate open-angle glaucoma underwent KDB-phaco or iStent-phaco in one eye and the alternate procedure in the fellow eye as part of a prospective, multicenter, randomized trial. Specular microscopy and pachymetry were performed before and 6-29 months after surgery. Parameters analyzed included change from baseline of endothelial cell density (ECD), the coefficient of variation (CV), the percent of hexagonal cells (%HEX), and central corneal thickness (CCT).

Results: Baseline ECD, CV, %HEX, and CCT were similar between groups. A mean (standard deviation) of 18.2 (5.8) months postoperatively (range 12.5-28.7 months), the change from baseline in ECD was -90 ± 226 cells/mm² (-3.4%) in KDB-phaco eyes (p=0.083) and -239 ± 247 cells/mm² (-9.0%) in iStent-phaco eyes (p<0.001); the change in iStent-phaco eyes was significantly greater than in KDB-phaco eyes (p=0.013). The magnitude of Endothelial Cell Loss (ECL) was not correlated with length of postoperative follow-up time in either group. No significant differences in change from baseline in CV, %HEX, or CCT were noted with the exception of a decrease in %HEX in iStent-phaco eyes (p=0.017). No eyes manifested corneal edema, decompensation, or other cornea-related complications.

Conclusion: Both KDB-phaco and iStent-phaco are associated with postoperative ECL, with iStent-phaco producing significantly greater ECL than KDB-phaco. The clinical significance of these findings is unclear, and future studies are warranted to more robustly characterize long-term effects of glaucoma surgical procedures-with and without permanent implants-on ECD and corneal health and to develop evidence-based guidelines for the pre- and post-operative evaluation of corneal health in eyes undergoing glaucoma surgery.

SUBMITTER: Dorairaj S

PROVIDER: S-EPMC7700000 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Corneal Endothelial Cell Changes After Phacoemulsification Combined with Excisional Goniotomy with the Kahook Dual Blade or iStent: A Prospective Fellow-Eye Comparison.

Dorairaj Syril S Balasubramani Goundappa K GK

Clinical ophthalmology (Auckland, N.Z.) 20201124

<h4>Purpose</h4>To characterize changes in endothelial cell density and morphology following phacoemulsification combined with either excisional goniotomy with the Kahook Dual Blade (KDB-phaco) or first-generation iStent trabecular microbypass implantation (iStent-phaco).<h4>Setting</h4>A single clinical practice.<h4>Methods</h4>Twenty-one adult subjects from one center with visually significant cataract and mild-moderate open-angle glaucoma underwent KDB-phaco or iStent-phaco in one eye and the ...[more]

PMID: 33262569

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Project description:PURPOSE:To compare the efficacy and safety of combined cataract extraction and either excisional goniotomy performed with the Kahook Dual Blade (KDB; phaco-KDB group) or single iStent trabecular bypass implantation (phaco-iStent group) in eyes with mild to moderate glaucoma and visually significant cataract. METHODS:This was a retrospective analysis of 315 eyes from 230 adults with mild or moderate glaucoma treated with one or more intraocular pressure (IOP)-lowering medications (190 eyes of 134 subjects in the phaco-KDB group and 125 eyes of 96 subjects in the phaco-iStent group) that required no subsequent surgical intervention for IOP control through 12 months of follow-up. Data included best-corrected visual acuity (BCVA), IOP, and IOP-lowering medications, collected preoperatively and at 1 week and 1, 3, 6, and 12 months postoperatively as well as intraoperative and postoperative adverse events. The primary efficacy outcomes were the proportion of subjects in each group achieving ≥ 20% IOP reduction and ≥ 1 medication reduction at month 12. Subgroup analysis by baseline IOP (≤ 18 mmHg vs. > 18 mmHg) was also performed. RESULTS:Mean (standard error) baseline IOP was 18.2 (0.3) mmHg in the phaco-KDB group and 16.7 (0.3) mmHg in the phaco-iStent group (p = 0.001). Statistically significant mean IOP and mean IOP medication reductions from baseline were achieved at all time points in both groups. Mean IOP reductions were significantly greater in the phaco-KDB group than in the phaco-iStent group at all time points including month 12 [- 5.0 (0.3) mmHg vs. - 2.3 (0.4) mmHg, p < 0.001], while mean medication reductions were similar between groups at all time points except week 1, when greater mean medication reduction was seen in the phaco-iStent group (- 1.23 vs. - 0.60 medications, p < 0.001). At month 12, IOP reductions ≥ 20% were achieved by 64.2% and 41.6% (p < 0.001) in the phaco-KDB and phaco-iStent groups, respectively, and IOP medication reductions of ≥ 1 medication were achieved by 80.4% and 77.4% (p = 0.522), respectively. Intraocular pressure subgroup analysis revealed significant reductions in IOP-lowering medications without compromise of IOP control in lower IOP subgroups and significant reductions in both IOP and IOP-lowering medications in the higher IOP subgroups. The most common adverse events were transient IOP elevations and transient anterior chamber inflammation, which occurred with similar frequency in both groups and resolved spontaneously. CONCLUSION:Goniotomy with the KDB lowered IOP significantly more than iStent implantation, with few adverse events in both groups. In eyes with mild to moderate glaucoma undergoing combined cataract extraction and glaucoma surgery, goniotomy with the KDB can safely deliver statistically significant and clinically meaningful reductions in both IOP and IOP medication burden through 12 months of follow-up. FUNDING:New World Medical, Inc., provided funding for the study, medical writing assistance, Rapid Service Fees, and the open access fee.

Project description:BackgroundTo compare the efficacy and safety of gonioscopy-assisted transluminal trabeculotomy (GATT) and Kahook Dual Blade (KDB) excisional goniotomy in patients with uncontrolled juvenile open-angle glaucoma (JOAG).MethodsThirty-three patients (46 eyes) were included in this single-center, retrospective, comparative study and treated with GATT (36 eyes) or KDB goniotomy (13 eyes). Intraocular pressure (IOP), number of glaucoma medications, adverse events, and additional anti-glaucoma procedures were collected during pre- and postoperative visits. Surgical success was defined as 6 mmHg ≤ IOP ≤ 18 mmHg and ≥ 20% IOP reduction from baseline with (partial success) or without (complete success) IOP-lowering medications.ResultsThe mean ± SD preoperative IOP was 30.48 ± 12.9 mmHg and 26.08 ± 13.1 mmHg (P = 0.164) on 3.71 ± 0.46 and 3.08 ± 0.86 (P = 0.023) glaucoma medications in GATT and KDB group, respectively. At 3 months, the mean ± SD IOP was 15.48 ± 5.93 mmHg and 20.0 ± 10.8 mmHg after GATT and KDB, respectively (P = 0.072). The percentage of IOP lowering from baseline was 44.4 in the GATT group and 14.1 in the KDB group (P = 0.011). The mean reduction in medications was 2.6 ± 1.7 and 0.8 ± 1.2 three months after GATT and KDB, respectively (P < 0.001). Cumulative proportion of partial and complete success were 65.6 and 44.7% in the GATT group, 30.8 and 15.4% in the KDB group at 6 months. Additional procedures were required in 13.9% of cases after GATT and in 61.5% after KDB (P = 0.001). Patients in the GATT group with prior anti-glaucoma procedures and postoperative IOP spikes were more likely to fail, while those with complete trabeculotomy had a better prognosis.ConclusionsReduction of IOP and medications were greater after GATT in uncontrolled JOAG eyes. Whereas, more additional IOP-lowering procedures were required after KDB goniotomy.Trial registrationThis study was registered under the Chinese Clinical Trial Registry ( ChiCTR2000034172 , 27/06/2020).

Project description:OBJECTIVE:This study sought to compare the effects and outcomes of two ophthalmic viscosurgical devices, 1.6% hyaluronic acid/4.0% chondroitin sulfate and 2.0% hydroxypropylmethylcellulose, during phacoemulsification. METHODS:This prospective, randomized clinical trial comprised 78 eyes (39 patients) that received phacoemulsification performed by the same surgeon using a standardized technique. Patients were randomly assigned to receive either 1.6% hyaluronic acid/4.0% chondroitin sulfate or 2.0% hydroxypropylmethylcellulose on the first eye. The other eye was treated later and received the other viscoelastic agent. Preoperative and postoperative examinations (5, 24 and 48 hours; 7 and 14 days; 3 and 6 months) included measurements of the total volume of the ophthalmic viscosurgical device, ultrasound and washout times to completely remove the ophthalmic viscosurgical device, intraocular pressure, central corneal thickness and best-corrected visual acuity. The corneal endothelial cell count was measured at baseline and at six months postoperatively. ClinicalTrials.gov: NCT01387620. RESULTS:There were no statistically significant differences between groups in terms of cataract density or ultrasound time. However, it took longer to remove 2.0% hydroxypropylmethylcellulose than 1.6% hyaluronic acid/ 4.0% chondroitin sulfate, and the amount of viscoelastic material used was greater in the 2.0% hydroxypropylmethylcellulose group. In addition, the best-corrected visual acuity was significantly better in the hyaluronic acid/ chondroitin sulfate group, but this preferable outcome was only observed at 24 hours after the operation. There were no statistically significant differences between the two ophthalmic viscosurgical devices regarding the central corneal thickness or intraocular pressure measurements at any point in time. The corneal endothelial cell count was significantly higher in the hyaluronic acid/chondroitin sulfate group. CONCLUSION:The ophthalmic viscosurgical device consisting of 1.6% hyaluronic acid/4.0% chondroitin sulfate was more efficient during phacoemulsification and was easier to remove after IOL implantation than 2.0% hydroxypropylmethylcellulose. In addition, the corneal endothelial cell count was significantly higher following the use of hyaluronic acid/chondroitin sulfate than with hydroxypropylmethylcellulose, which promoted an improved level of corneal endothelium protection.

Project description:PurposeThe study aimed to compare the 12-month post-operative outcomes of iStent and iStent inject W (inject W), and the factors associated with their success in open-angle glaucoma.MethodsThis single-center, retrospective comparative case series evaluated the medical records of patients who underwent iStent (comprising 1 stent) or inject W (comprising 2 stents) implantation with cataract surgery for primary open-angle glaucoma and normal tension glaucoma between January 2019 and March 2022. The 12-month post-operative efficacy outcomes included intraocular pressure (IOP), glaucoma medications, and survival analysis of the probability of success. "Failure" was defined as any of the following conditions compared to baseline: 1) IOP elevation, 2) increased glaucoma medication, or 3) IOP decline not exceeding 20% when glaucoma medication scores were comparable, and 4) need for additional glaucoma surgery. The safety outcomes included intra- and post-operative adverse events and changes in the best-corrected visual acuity and visual field.ResultsThe study comprised 55 eyes in the iStent and 105 in the inject W groups. At 12 months, treatment success was achieved in 66.0% of iStent and 78.4% of inject W eyes. The mean IOP was lower, and the percent reduction from baseline was equal in iStent-treated eyes (8.0% reduction, 14.8 mmHg to 13.7 mmHg, P<0.01) and inject W-treated eyes (11.9% reduction, 15.0 mmHg to 13.8 mmHg, P<0.01) (between-group comparison, P = 0.23). The mean medication burden decreased significantly from 2.5 to 1.1 for iStent (55.0% reduction, P<0.01) and 2.9 to 1.7 for iStent inject (46.8% reduction, P<0.01), with no significant differences between the two groups (P = 0.17). Both devices exhibited excellent safety.ConclusionsBoth devices significantly reduced IOP and glaucoma medication 12 months post-operatively. The outcome measures did not differ significantly between the two groups, and lower baseline IOP was predictive of surgical failure.

Project description:BackgroundMinimally invasive glaucoma surgeries (MIGS) have attracted significant attention, as they have been reported to lower intra-ocular pressure (IOP) and have an excellent safety profile. The iStent is an example of a minimally invasive glaucoma device that has received particular attention due to its early and wide spread utilization. There is a growing body of evidence supporting its use at the time of phacoemulsification to help lower IOP. However, it is still not clear how much of the IOP lowering effect can be attributed to the iStent, the crystalline lens extraction or both when inserted concurrently at the time of phacoemulsification. This has been an important issue in understanding its potential role in the glaucoma management paradigm.PurposeTo conduct a systematic review and meta-analysis comparing the IOP lowering effect of iStent insertion at the time of phacoemulsification versus phacoemulsification alone for patients with glaucoma and cataracts.MethodsA systematic review was conducted utilizing various databases. Studies examining the IOP lowering effect of iStent insertion in combination with phacoemulsification, as well as studies examining the IOP lowering effect of phacoemulsification alone were included. Thirty-seven studies, reporting on 2495 patients, met the inclusion criteria. The percentage reduction in IOP (IOPR%) and mean reduction in topical glaucoma medications after surgery were determined. The standardized mean difference (SMD) was computed as a measure of the treatment effect for continuous outcomes taking into account heterogeneity. Fixed-effect and random-effect models were applied.ResultsA 4% IOP reduction (IOPR%) from baseline occurred following phacoemulsification as a solo procedure compared to 9% following an iStent implant with phacoemulsification, and 27% following 2 iStents implants with phacoemulsification. Compared with cataract extraction alone, iStent with phacoemulsification resulted in significant reduction in the post-operative IOP (IOPR%) (SMD = -0.46, 95% CI: [-0.87, -0.06]). A weighted mean reduction in the number of glaucoma medications per patient was 1.01 following phacoemulsification alone compared to 1.33 after one iStent implant with phacoemulsification, and 1.1 after 2 iStent implants with phacoemulsification. Compared to cataract extraction alone, iStent with cataract extraction showed a significant decrease in the number of glaucoma medications (SMD = -0.65, 95% CI: [-1.18, -0.12]). Funnel plots suggested the absence of publication bias.ConclusionBoth iStent implantation with concurrent phacoemulsification and phacoemulsification alone result in a significant decrease in IOP and topical glaucoma medications. In terms of both reductions, iStent with phacoemulsification significantly outperforms phacoemulsification alone.

Project description:BackgroundTo examine the risk factors for an early postoperative intraocular pressure (IOP) increase after ab interno trabeculotomy using a Kahook Dual Blade (KDB trabeculotomy).MethodsA retrospective study was performed in 76 exfoliation glaucoma (EXG) eyes and 56 primary open angle glaucoma (POAG) eyes that underwent KDB trabeculotomy, with or without cataract surgery at Kumamoto University Hospital. Postoperative high IOP was classified as IOP≥20 mmHg (within three months after surgery, whether persistent or temporary), transient IOP≥20 mmHg (IOP≥20 mmHg after surgery, then dropped below 20 mmHg), and the presence of IOP spikes (≥ 10 mmHg from baseline). Risk factors were examined using logistic regression analysis.ResultsThe preoperative mean IOP (SD) was 24.98 (7.23) mmHg in patients with EXG and 21.28 (6.58) mmHg in patients with POAG. IOP was reduced by 32.1% in patients with EXG and by 17.7% in patients with POAG at 6 months after surgery. Postoperative IOP≥20 mmHg was observed in 56.6% of EXG patients and in 51.8% of POAG patients. IOP spikes occurred in 15.8% of EXG patients and in 14.3% of POAG patients. Logistic regression analysis showed that factors with significant odds ratios (ORs) were age (OR = 0.866, 95% CI = 0.793-0.945), preoperative medication use (OR = 2.02, 95% CI = 1.17-3.49), trabeculotomy in combination with cataract surgery (OR = 0.0674, 95% CI = 0.015-0.303), and IOP at day 1 (OR = 1.41, 95% CI = 1.18-1.68) for postoperative IOP≥20 mmHg, the IOP at day 1 (OR = 1.1, 95% CI = 1.03-1.17) for transient IOP≥20 mmHg, and age (OR = 0.948, 95% CI = 0.901-0.997) and preoperative IOP (OR = 0.83, 95% CI = 0.736-0.936) for IOP spikes.ConclusionAlthough KDB trabeculotomy is an effective treatment for patients with EXG and POAG, patients who take multiple preoperative medications and have a high IOP on day 1 require careful follow-up to prevent postoperative IOP elevation.

Dataset Information

Corneal Endothelial Cell Changes After Phacoemulsification Combined with Excisional Goniotomy with the Kahook Dual Blade or iStent: A Prospective Fellow-Eye Comparison.

Publications

Corneal Endothelial Cell Changes After Phacoemulsification Combined with Excisional Goniotomy with the Kahook Dual Blade or iStent: A Prospective Fellow-Eye Comparison.

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