Automated Direct Selective Laser Trabeculoplasty: First Prospective Clinical Trial.
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ABSTRACT: Purpose
Direct selective laser trabeculoplasty (DSLT) is a rapid, noncontact automated procedure performed directly through the limbus without gonioscopy. In this first nonrandomized clinical trial we assessed its safety and ability to reduce intraocular pressure (IOP).Methods
Fifteen patients (15 eyes: 10 with open-angle glaucoma [OAG], 4 with ocular hypertension, and 1 with pseudoexfoliation glaucoma), naive or after medication washout, with an IOP ≥22 mm Hg, underwent DSLT by irradiation with 100 or 120 sequential noncontact 532-nm, Q-switched laser shots (0.8-1.4 mJ) automatically applied during 1.5 or 2.3 seconds on the limbus, guided by image analysis and eye tracking. Results were assessed at 1 and 3 hours, 1 day, 1 week, and 1, 3, and 6 months.Results
The mean ± standard deviation baseline IOP (mm Hg) in all eyes was 26.7 ± 2.3. At 1, 3, and 6 months, this value was significantly reduced to 21.7 ± 4.2 (by 18.1%), to 20.8 ± 2.5 (by 21.4%), and to 21.5 ± 4.1 (by 18.8%), respectively. In six patients treated with 1.4 mJ/shot, the mean IOP at 6 months decreased from 26.7 ± 3.2 to 19.3 ± 2.0 (27.1%, P = 0.03). There was a significant reduction in hypotensive medications (from 1.6 ± 1.0 to 0.4 ± 0.7, P = 0.03). No serious adverse events occurred.Conclusions
Automated DSLT appears to be an effective and safe noncontact, rapid modality for reducing IOP in patients with OAG. Higher energy usage led to better results.Translational relevance
Studying laser transmission through sclera enabled laser irradiation of the trabeculum without gonioscopy.
SUBMITTER: Goldenfeld M
PROVIDER: S-EPMC7938021 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Aim:The aim of this study was to prospectively compare the efficacy, safety, and tolerability of selective laser trabeculoplasty (SLT) vs micropulse laser trabeculoplasty (MLT) in reducing intraocular pressure (IOP) in open-angle glaucoma patients. Patients and methods:In all, 38 patients were randomized to 360° MLT and 31 patients were randomized to 360° SLT. IOP was measured at intervals of 1 hour and 1, 1-6, 6-12, 6-24, 24-36, and 36-52 weeks. Patients completed a survey 1 week after the procedure. Patients with end-stage, neovascular, uveitic, or angle-closure glaucoma were excluded. Treatment response was defined as an IOP reduction of ?20.0% or ?3 mmHg from baseline. Results:IOP was lowered to ?3 mmHg from baseline among 37.0% of the micropulse patients and 36.0% of patients in the selective laser group at 24-52 weeks. Similarly, 29.6% of the micropulse patients and 36.0% of the selective laser patients experienced a 20.0% IOP decrease from baseline during the 24-52-week interval (P=0.77). Both groups revealed similar reductions in IOP as absolute values and percentage decreases from baseline at all intervals up to 52 weeks post treatment. There were more treatment failures in the micropulse group up to 52 weeks post laser treatment; however, this was not statistically significant. The micropulse group reported less pain both during and after the procedure (P=0.005). Conclusion:Micropulse trabeculoplasty has demonstrated similar efficacy to SLT over a 52-week follow-up period with less discomfort experienced both during and after the procedure.
| S-EPMC6124459 | biostudies-literature
Project description:IntroductionLaser trabeculoplasty is an effective and widely used treatment for glaucoma. A new laser technology, the Eagle direct selective laser trabeculoplasty (DSLT) device, may provide automated, fast, simple, safe and effective laser treatment for glaucoma in a broader range of clinical settings. This trial aims to test the hypothesis that translimbal DSLT is effective and not inferior to selective laser trabeculoplasty (SLT) in reducing intraocular pressure (IOP) in open angle glaucoma (OAG).Methods and analysisThis is a multicentre, randomised, controlled, investigator-masked study. The primary efficacy outcome is intergroup difference in mean change from baseline IOP measured at 6 months. Secondary outcomes include mean percentage reduction in IOP at 3, 6 and 12 months; proportion of participants with at least 20% reduction in IOP from baseline at 6 months; change in ocular hypotensive medications at 12 months and evaluation of safety. Participants were aged >= 40 years with OAG, including exfoliative or pigmentary glaucoma, or ocular hypertension with untreated or washed out IOP 22-35 mm Hg.TreatmentsDSLT: 120 shots, 3 ns, 400 µm spot size, energy 1.4-1.8 mJ delivered at the limbus over 2 s. SLT: approximately 100 shots, 3 ns, 400 µm spot size administered 360 degrees at the limbus using any gonioscopy lens, energy 0.3-2.6 mJ. A sample size of 164 is sufficient to detect a non-inferiority margin of 1.95 mm Hg for change from baseline IOP.Clinical trial registration numberNCT03750201, ISRCTN14033075.
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Project description:PurposeThis case report describes two glaucoma patients who underwent selective laser trabeculoplasty (SLT) and developed a rare post-procedure corneal complication and subsequent permanent corneal distortions and reduced acuity.ObservationsBoth patients experienced early post-procedure corneal edema, reduced visual acuity, and pain. Each patient was treated with topical steroids with resolution of the edema, but each patient had irregular corneal astigmatism which was not present pre-operatively and did not resolve.Conclusions and importanceThere are very few reported cases of post-SLT corneal edema and these typically resolve without long-term complications. The following two cases represent an uncommon adverse event of irregular corneal astigmatism despite resolution of the corneal edema. The exact mechanism of these corneal effects is not known. Practitioners should inform patients of this rare, but possible complication following SLT and consider extra precautions in patients susceptible to corneal edema.
| S-EPMC5956624 | biostudies-literature
Project description:PurposeTo evaluate the effectiveness and safety of Selective Laser Trabeculoplasty (SLT) with the SLT mode of the VISULAS® green laser in patients with primary open-angle glaucoma (POAG).MethodsThis prospective, interventional multicenter clinical investigation included patients with POAG who either needed a treatment escalation because the individual intraocular pressure (IOP) target was not met or treatment initiation and had an IOP ≥ 17 mmHg at baseline in the study eye. The study was conducted in five research centers across Germany. Approximately 100 laser applications were delivered to 360° of the trabecular meshwork. Glaucoma medications were not modified during the 3-month follow-up to allow evaluation of the sole effect of VISULAS® green with SLT. Efficacy outcomes were postoperatively absolute and relative IOP changes at 1 and 3 months. Safety outcomes analyzed the rate of intra- and postoperative adverse events.ResultsThirty-four eyes of 34 POAG patients were included. The overall mean number of preoperative glaucoma medications was 2.2 ± 1.4 in 29 treated eyes, 5 eyes were treatment naïve. Mean baseline IOP (mmHg) was 21.0 ± 2.69 and was reduced by - 3.53 ± 3.34 [95% CI - 4.61; - 2.45] and - 3.59 ± 3.41 [95% CI - 4.64; - 2.53] at the 1- and 3-month follow-up, respectively (p < 0.0001), with 48.5% of cases achieving a ≥ 20% IOP reduction at 3 months [95% CI = 30.8%; 66.5%]. The mean relative IOP reduction was - 16.4% and - 16.3% at 1 and 3 months, respectively (p < 0.0001). Potentially device- or procedure-related adverse events were mild to moderate and included 3 postoperative IOP-spikes and 6 reports regarding eye pain and discomfort. All were resolved without sequelae.ConclusionsSLT performed with the VISULAS® green laser achieved clinically significant additional IOP reductions in medically treated as well as in treatment naïve eyes with POAG and there were no relevant safety issues. The results are comparable to other reported SLT studies.
| S-EPMC10313537 | biostudies-literature
Project description:This article aims to investigate the clinical results at 2 years after selective laser trabeculoplasty (SLT) for normal tension glaucoma (NTG). This prospective cohort study recruited NTG patients taking antiglaucoma medication. Subjects were excluded if they had previous glaucoma surgery/laser or corneal pathologies. All subjects underwent a 1-month washout. A single session of SLT was performed to 360° of the trabecular meshwork. Medication was resumed at 1 month to achieve a targeted 30% intraocular pressure (IOP) reduction from the post-washout/pre-SLT IOP. IOP was measured every 3 months and medication use was recorded at 3, 6, 12, and 24 months. Subjects with a secondary SLT or cataract extraction were excluded from IOP and medication analyses. At 24 months, 34 of the initial 45 right eyes were eligible for analyses. There were significant IOP reductions at all time intervals (except at 1 week) following SLT when compared to the prestudy (without medication) or pre-SLT (post-washout) IOP (P < 0.0001). Medications were likewise significantly reduced at all time intervals following SLT (P < 0.0001). At 24 months, the IOP was 11.5% lower than the prestudy IOP, 22.0% lower than the pre-SLT IOP, and medication use was reduced by 41.1% (P < 0.0001). Six out of 45 eyes (13.3%) required a secondary SLT. Absolute success (IOP reduction >20% from pre-SLT, without medication) was achieved in 11.1% (5/45). Reductions in IOP and medication use were evident at 2 years following SLT for the treatment of NTG whereas 11% remained medication free.The Clinical Trials Register of the University of Hong Kong HKCTR1847. The European Clinical Trials Database 2014-003305-15 (August 11, 2014).
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Project description:BACKGROUND:To compare the effect of selective laser trabeculoplasty (SLT) and travoprost on 24-hour IOP fluctuations in primary open-angle glaucoma (POAG) and normal-tension glaucoma (NTG). METHODS:Sixty eyes were included. Sixteen and 14 eyes of POAG patients were randomized to receive 360° SLT or 0.004% travoprost, respectively. Fourteen and 16 eyes of NTG patients were randomized to receive either SLT or travoprost, respectively. The 24-hour IOP data were collected before treatment and 6 to 8 weeks after treatment. IOP was measured at 2?hours intervals in the sitting position during daytime (9 AM to 7 PM) and in the supine position during nighttime (9 PM to 7 AM). Main outcome measure was the percentage of eyes that achieved posttreatment 24-hour IOP fluctuations <3?mm?Hg. Success in fluctuation reduction was defined as at least a 50% reduction in these fluctuations. RESULTS:Fifty-eight eyes were analyzed. Overall, eyes in the SLT and the travoprost groups achieved a significant reduction in IOP compared with the baseline IOP values (-3.7?mm Hg [P?=?0.002] vs -4.1?mm Hg [P?<?0.001], respectively). There was no significant difference in IOP reduction in both groups according to type of glaucoma. During the diurnal period, 100% of POAG eyes in the travoprost group achieved posttreatment IOP fluctuations <3?mm Hg, and 87% of eyes in the SLT group achieved the same level of fluctuations (P?<?0.001). Ninety-six percent of NTG eyes in the travoprost group, and 82% of eyes in the SLT group had IOP fluctuations <3?mm Hg (P?=?0.01). Success in fluctuation reduction was 75% and 92% for the SLT and travoprost groups, respectively (P?=?0.005). The effect of travoprost on IOP reduction in POAG and NTG patients was significant both during the daytime and the nighttime, while the SLT's effect was significant only during the nighttime. CONCLUSIONS:Both travoprost and SLT can significantly reduce the IOP in patients with POAG and NTG. Based on habitual positions, travoprost better controls IOP fluctuations than SLT, especially during the daytime.
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Project description:BackgroundTrabecular meshwork and Schlemm's canal are the tissues appointed to modulate the aqueous humour outflow from the anterior chamber. The impairment of their functions drives to an intraocular pressure increase. The selective laser trabeculoplasty is a laser therapy of the trabecular meshwork able to decrease intraocular pressure. The exact response mechanism to this treatment has not been clearly delineated yet. The herein presented study is aimed at studying the gene expression changes induced in trabecular meshwork cells by selective laser trabeculoplasty (SLT) in order to better understand the mechanisms subtending its efficacy.Methodology/principal findingsPrimary human trabecular meshwork cells cultured in fibroblast medium underwent selective laser trabeculoplasty treatment. RNA was extracted from a pool of cells 30 minutes after treatment while the remaining cells were further cultured and RNA was extracted respectively 2 and 6 hours after treatment. Control cells stored in incubator in absence of SLT treatment were used as reference samples. Gene expression was evaluated by hybridization on miRNA-microarray and laser scanner analysis. Scanning electron microscopic examination was performed on 2 Trabecular meshwork samples after SLT at 4(th) and 6(th) hour from treatment. On the whole, selective laser trabeculoplasty modulates in trabecular meshwork the expression of genes involved in cell motility, intercellular connections, extracellular matrix production, protein repair, DNA repair, membrane repair, reactive oxygen species production, glutamate toxicity, antioxidant activities, and inflammation.Conclusions/significanceSLT did not induce any phenotypic alteration in TM samples. TM is a complex tissue possessing a great variety of function pivotal for the active regulation of aqueous humour outflow from the anterior chamber. SLT is able to modulate these functions at the postgenomic molecular level without inducing damage either at molecular or phenotypic levels.
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Project description:ObjectiveTo examine possible differences in clinical outcomes between selective laser trabeculoplasty (SLT) and argon laser trabeculoplasty (ALT) in open-angle glaucoma at different times post-treatment.MethodsRandomized controlled trials (RCTs) comparing SLT versus ALT were searched through August 2013. The main outcome measure was IOP, and secondary outcomes included the number of glaucoma medications, the success rate, and adverse events.ResultsSix RCTs, involving 482 eyes treated with laser trabeculoplasty, were included in the meta-analysis. For all patients (including first and previous laser trabeculoplasy), no significant difference in IOP lowering was observed between SLT and ALT at one hour (P = 0.40), one week (P = 0.72), one month (P = 0.37), six months (P = 0.08), one year (P = 0.34), two years (P = 0.58), three years (P = 0.34), four years (P = 0.47), and five years (P = 0.50). A statistically significant difference in favor of SLT was found when comparing the IOP reduction at three months after intervention (weighted mean difference (WMD): 1.19 mmHg [0.41; 1.97]; I(2)=0%; P = 0.003). For patients who were naive to laser, there was no significant difference of reduction in IOP comparing SLT with ALT at any time point. In patients' previous LT, no statistically significant difference in IOP reduction was found at six months (WMD: 1.92 mmHg [-0.91; 4.74]; I(2) = 77.3%; P = 0.18). There was no significant difference in the reduction in the number of glaucoma medications, the success rate, or adverse event rates between the two treatments.ConclusionsSLT has equivalent ef?cacy to ALT with a similar constellation of side effects. In the case of retreatment, SLT appears to be similar to ALT in IOP lowering at six months.
| S-EPMC3868565 | biostudies-literature
Project description:AbstractThis article aims to investigate the clinical results at 2 years after selective laser trabeculoplasty (SLT) for normal tension glaucoma (NTG).This prospective cohort study recruited NTG patients taking antiglaucoma medication. Subjects were excluded if they had previous glaucoma surgery/laser or corneal pathologies. All subjects underwent a 1-month washout. A single session of SLT was performed to 360° of the trabecular meshwork. Medication was resumed at 1 month to achieve a targeted 30% intraocular pressure (IOP) reduction from the post-washout/pre-SLT IOP. IOP was measured every 3 months and medication use was recorded at 3, 6, 12, and 24 months. Subjects with a secondary SLT or cataract extraction were excluded from IOP and medication analyses.At 24 months, 34 of the initial 45 right eyes were eligible for analyses. There were significant IOP reductions at all time intervals (except at 1 week) following SLT when compared to the prestudy (without medication) or pre-SLT (post-washout) IOP (P < 0.0001). Medications were likewise significantly reduced at all time intervals following SLT (P < 0.0001). At 24 months, the IOP was 11.5% lower than the prestudy IOP, 22.0% lower than the pre-SLT IOP, and medication use was reduced by 41.1% (P < 0.0001). Six out of 45 eyes (13.3%) required a secondary SLT. Absolute success (IOP reduction >20% from pre-SLT, without medication) was achieved in 11.1% (5/45).Reductions in IOP and medication use were evident at 2 years following SLT for the treatment of NTG whereas 11% remained medication free.Trial Registrations: The Clinical Trials Register of the University of Hong Kong HKCTR1847. The European Clinical Trials Database 2014-003305-15 (August 11, 2014).
| S-EPMC4915851 | biostudies-other
Project description:BackgroundPrimary open angle glaucoma and ocular hypertension are habitually treated with eye drops that lower intraocular pressure. Selective laser trabeculoplasty is a safe alternative but is rarely used as first-line treatment. We compared the two.MethodsIn this observer-masked, randomised controlled trial treatment-naive patients with open angle glaucoma or ocular hypertension and no ocular comorbidities were recruited between 2012 and 2014 at six UK hospitals. They were randomly allocated (web-based randomisation) to initial selective laser trabeculoplasty or to eye drops. An objective target intraocular pressure was set according to glaucoma severity. The primary outcome was health-related quality of life (HRQoL) at 3 years (assessed by EQ-5D). Secondary outcomes were cost and cost-effectiveness, disease-specific HRQoL, clinical effectiveness, and safety. Analysis was by intention to treat. This study is registered at controlled-trials.com (ISRCTN32038223).FindingsOf 718 patients enrolled, 356 were randomised to the selective laser trabeculoplasty and 362 to the eye drops group. 652 (91%) returned the primary outcome questionnaire at 36 months. Average EQ-5D score was 0·89 (SD 0·18) in the selective laser trabeculoplasty group versus 0·90 (SD 0·16) in the eye drops group, with no significant difference (difference 0·01, 95% CI -0·01 to 0·03; p=0·23). At 36 months, 74·2% (95% CI 69·3-78·6) of patients in the selective laser trabeculoplasty group required no drops to maintain intraocular pressure at target. Eyes of patients in the selective laser trabeculoplasty group were within target intracoluar pressure at more visits (93·0%) than in the eye drops group (91·3%), with glaucoma surgery to lower intraocular pressure required in none versus 11 patients. Over 36 months, from an ophthalmology cost perspective, there was a 97% probability of selective laser trabeculoplasty as first treatment being more cost-effective than eye drops first at a willingness to pay of £20 000 per quality-adjusted life-year gained.InterpretationSelective laser trabeculoplasty should be offered as a first-line treatment for open angle glaucoma and ocular hypertension, supporting a change in clinical practice.FundingNational Institute for Health Research, Health and Technology Assessment Programme.
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