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Background To compare the success and safety of microcatheter-assisted 360° trabeculotomy (MCAT) with conventional probe trabeculotomy in a large, heterogeneous cohort of children with primary or secondary glaucoma. Methods In this prospective, multicenter, observer-blinded, randomized controlled trial, 76 children (152 eyes) with bilateral primary or secondary childhood glaucoma aged ≤ 12 years will be included. Each child acts as own control using a paired-eye design: One eye is allocated to MCAT (experimental intervention), achieving a 360° trabeculotomy, the other eye to the probe trabeculotomy (control intervention) which enables a trabeculotomy over 90 to 120°. Each child receives both procedures (paired-eye design). The worse eye is treated first; the surgical method is randomized. Patients and observers are masked to the procedures. The patients are followed up for 24 months. The primary endpoint is complete success (IOP < 18 mmHg at 24 months without medication and revision surgery; with MCAT: successful probing of > 120° is also required for success) at 24 months of follow-up. The primary analysis is performed in the intention-to-treat population using McNemar test stratified by center. Discussion The PIRATE study is a multicenter randomized controlled study comparing MCAT with conventional probe trabeculotomy in a large and heterogeneous childhood glaucoma population. It will provide data on the success and safety of both techniques and clarify if MCAT is superior to probe trabeculotomy. Trial registration German Clinical Trials Register, DRKS-ID: DRKS00034139. Registered on April 24, 2024. https://drks.de/search/en/trial/DRKS00034139 . https://trialsearch.who.int/Trial2.aspx?TrialID=DRKS00034139 .

Background Neovascular glaucoma (NVG) is an irreversible blinding eye disease worldwide and is classified as one of the refractory glaucoma conditions, severely impacting visual function and vision. Unfortunately, effective surgical interventions to improve the prognosis of NVG patients are currently lacking. The study aims to evaluate the efficacy and safety of anterior chamber proliferative membrane interception (AC-PMI)-enhanced trabeculectomy compared to the traditional trabeculectomy. Methods AC-PMI enhanced trabeculectomy versus trabeculectomy for the treatment of NVG is a single-center, prospective, double-arms, and randomized controlled trial of superior efficacy, which will involve 100 NVG inpatients. Patients will be randomly assigned into two groups using the random number table method. One group will undergo trabeculectomy using anti-vascular endothelial growth factor (Anti-VEGF) preoperatively and mitomycin C intraoperatively, while the other group will undergo AC-PMI enhanced trabeculectomy with the same medications (Anti-VEGF and mitomycin C). The patients will be followed up at the baseline and 1 day, 1 week, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months postoperatively. Meanwhile, we will collect the demographics, characteristics, and examination results and monitor any occurrences of adverse events at each follow-up time. Discussion This is an efficacy study of a novel surgical approach for treating neovascular glaucoma. Building upon conventional filtering surgeries, this approach introduces an additional step involving the interception of the proliferative membrane to effectively halt the growth of fibrovascular tissue. This study aims to explore a promising new surgical approach for managing NVG and contribute to the advancement of glaucoma treatment strategies. Trial registration ChiCTR ChiCTR2200055138. Registered on 01 January 2022. https://www.chictr.org.cn/showproj.html?proj=145255.

Aim: To compare 90°, 180°, and 360° selective laser trabeculoplasty (SLT, 532 nm Nd:YAG laser) with latanoprost 0.005% for the control of intraocular pressure (IOP) in ocular hypertension (OHT) and open angle glaucoma (OAG). Methods: A prospective, randomised clinical trial in the Department of Ophthalmology, St Thomas’s Hospital, London, and Clayton Eye Centre, Wakefield, West Yorkshire. 167 patients (167 eyes) with either OHT or OAG were randomised to receive 90°, 180°, and 360° SLT or latanoprost 0.005% at night and were evaluated at 1 hour, 1 day, 1 week and 1, 3, 6, and 12 months. Results: The mean follow up was 10.3 months (range 1–12 months). Early, transient, complications such as postoperative ocular pain, uveitis, and 1 hour IOP spike occurred in a number of eyes after SLT, with pain being reported more frequently after 360° than 90° treatments (p>0.001). Success rates defined in terms of both a 20% or more and a 30% or more IOP reduction from baseline measurements with no additional antiglaucomatous interventions were better with latanoprost than 90° (p<0.001) and 180° SLT (p<0.02) treatments. Differences in success rates between latanoprost and 360° SLT did not reach statistical significance (p<0.5). Success rates were greater with 180° and 360° compared to 90° SLT (p<0.05). With 360° SLT, 82% of eyes achieved a >20% IOP reduction and 59% a >30% reduction from baseline. Although success rates were better with 360° than 180° SLT treatments, differences did not reach statistical significance. There were no differences with regard to age, sex, race, pretreatment IOP, OHT versus OAG, laser power settings, and total laser energy delivered between eyes which responded, in terms of a >20% and a >30% IOP reduction, and those that did not respond with 180° and 360° SLT treatments. Conclusions: Success rates were higher with latanoprost 0.005% at night than with 90° and 180° SLT treatments. 90° SLT is generally not effective. 360° SLT appears to be an effective treatment with approximately 60% of eyes achieving an IOP reduction of 30% or more. Transient anterior uveitis with associated ocular discomfort is not unusual in the first few days after SLT. Late complications causing ocular morbidity after SLT were not encountered.

Aims: To compare selective laser trabeculoplasty (SLT) and argon laser trabeculoplasty (ALT), in terms of intraocular pressure (IOP) lowering, in patients with open-angle glaucoma. Methods: 176 eyes of 152 patients were enrolled in this study, 89 in the SLT and 87 in the ALT groups. Patients were randomised to receive either SLT or ALT treatment to 180° of the trabecular meshwork. Patients were followed up to 12 months after treatment. The main outcome measured was IOP lowering at 12 months after treatment, compared between the SLT and ALT groups. Results: No significant difference (p = 0.846) was found in mean decrease in IOP between the SLT (5.86 mm Hg) and ALT (6.04 mm Hg) groups at 1 year or at any other time points, nor were there any significant differences in the rate of early or late complications between the two groups. Conclusions: SLT is equivalent to ALT in terms of IOP lowering at 1 year, and is a safe and effective procedure for patients with open-angle glaucoma.

IntroductionPrimary angle-closure glaucoma (PACG) has a high prevalence and blinding rate across Asia. The first-line treatment of PACG is surgery, and phacotrabeculectomy remains the mainstream surgery for advanced PACG. However, it may cause vision-threatening complications with long learning curve. Minimally invasive glaucoma surgery has been gradually used in PACG combined with cataract surgery and achieved efficacy without excessive injury, of which goniotomy is the most commonly performed. Therefore, this study aimed to conduct a multicentre, non-inferiority randomised controlled clinical trial to compare the efficacy and safety of phacotrabeculectomy versus phacogoniotomy in advanced PACG.Methods and analysisThis is a non-inferiority multicentre randomised controlled trial and will be conducted at eight ophthalmic departments and institutes in China. 124 patients with advanced PACG will be enrolled and randomised to undergo phacotrabeculectomy or phacogoniotomy. Comprehensive ophthalmic examinations will be performed before and after the surgery. The primary outcome is the change of intraocular pressure at 12 months after surgery compared with the baseline intraocular pressure. An extended follow-up period of 36 months will be required. Cumulative success rate of surgery, intraoperative and postoperative complications, and number of anti-glaucomatous medications will also be compared between the groups as secondary outcomes.Ethics and disseminationEthical approval has been obtained from the ethical committee of Zhongshan Ophthalmic Center, Sun Yat-sen University, China (ID: 2021KYPJ090) and all subcentres. All the participants will be required to provide written informed consent. The results will be disseminated through scientific meetings and published in peer-reviewed journals.Trial registration numberNCT04878458.

In an African setting surgery is generally accepted as the treatment of first choice for glaucoma. A problem with trabeculectomy surgery for the glaucomas is the frequent co-existence and exacerbation of cataract. We report a randomized controlled trial to compare the use of beta radiation with 5FU in combined cataract and glaucoma surgery. Consenting adults aged >40 years with glaucoma, an IOP>21mmHG and cataract were enrolled and randomised to receive either 1000cG β radiation application or sub-conjunctival 5fluorouracil (5FU) at the time of combined trabeculectomy and phaco-emulsification with lens implant surgery. 385 individuals were eligible for inclusion of whom 301 consented to inclusion in the study (one eye per patient). 150 were randomised to the 5FU arm and 151 received β radiation. In the 12 months following surgery there were 40 failures (IOP>21mmHg) in the 5FU arm and 34 failures in the beta arm. The hazard ratio for the beta radiation arm compared to the 5FU arm, adjusted for IOP at baseline, was 0.83 (95% c.i. 0.54 to 1.28; P = 0.40). The improvement from mean presenting visual acuities of 0.91 and 0.86 logMAR to 0.62 and 0.54 in the 5FU and beta arms respectively was comparable between groups (P = 0.4 adjusting for baseline VA). Incidence of complications did not differ between the two groups. This study highlights several important issues in the quest for a therapeutic strategy for the glaucomas in an African context. Firstly, there is no evidence of an important difference between the use of 5FU and beta radiation as an anti-metabolite in phacotrabeculectomy. Secondly phacotrabeculectomy is a successful operation that improves visual acuity as well as controlling IOP in a majority of patients. Although the success of trabeculectomy in lowering IOP is reduced when combined with phacoemulsification compared with trabeculectomy alone, this finding has to be set against the possible need for subsequent cataract surgery following trabeculectomy alone, which represents a second trip and expense for the patient and results in 10-61% failure of the trabeculectomy at one year post-cataract surgery. ISRCTN Registry ISRCTN36436933.

Background Glaucoma is the leading cause of irreversible blindness in the world. Estimated to affect 60 million people worldwide, this figure is expected to rise to 80 million by 2020. Untreated, glaucoma leads to visual decay and eventually to blindness, and can significantly reduce quality of life. First-line treatment in patients with primary open-angle glaucoma and exfoliative glaucoma is topical medical therapy with ocular hypotensives as eye drops. However, eye drops have several disadvantages including cost, possible local and systemic side effects, and adherence and perseverance issues. Randomised controlled trials have demonstrated that selective laser trabeculoplasty is equally as effective in lowering intraocular pressure as eye drops. However, the impact of these two treatment modalities from the patient and economic perspectives has not been adequately determined. Thus, it remains unclear whether topical medical therapy or selective laser trabeculoplasty should be recommended as first-line treatment for glaucoma. Methods/Design This protocol describes an international, multi-centre, randomised controlled trial to determine the optimum first-line therapy for people with primary open-angle glaucoma and exfoliative glaucoma. This study will compare the effect of selective laser trabeculoplasty and topical medication with respect to patients’ generic and glaucoma-specific quality of life. The trial will also provide a detailed cost-effectiveness analysis and compare the clinical effectiveness with respect to the degree of intraocular pressure lowering and rates of treatment failure. Research coordinators in each centre will identify and recruit previously untreated patients with primary open-angle glaucoma and exfoliative glaucoma. Those who meet the eligibility criteria will be invited to enter a randomised controlled trial with either selective laser trabeculoplasty or topical ocular hypotensive therapy, according to a stepped regimen. Outcome assessment will be measured at 6 weeks and at 6, 12, and 24 months post-treatment. Regular clinic follow-ups will continue as clinically indicated between study outcome visits. Discussion The Glaucoma Initial Treatment Study is the first multi-centred RCT to determine the optimum first-line therapy for people with glaucoma. Our trial will have an unprecedented capacity to meaningfully transform the treatment and management of glaucoma in Australia and overseas. Trial registration ACTRN12611000720910 ; Date registered: 11 July 2011

Background The LiGHT trial (Laser-1st versus Drops-1st for Glaucoma and Ocular Hypertension Trial) is a multicentre randomised controlled trial of two treatment pathways for patients who are newly diagnosed with open-angle glaucoma (OAG) and ocular hypertension (OHT). The main hypothesis for the trial is that lowering intraocular pressure (IOP) with selective laser trabeculoplasty (SLT) as the primary treatment (‘Laser-1st’) leads to a better health-related quality of life than for those started on IOP-lowering drops as their primary treatment (‘Medicine-1st’) and that this is associated with reduced costs and improved tolerability of treatment. This paper describes the statistical analysis plan for the study. Methods/Design The LiGHT trial is an unmasked, multi-centre randomised controlled trial. A total of 718 patients (359 per arm) are being randomised to two groups: medicine-first or laser-first treatment. Outcomes are recorded at baseline and at 6-month intervals up to 36 months. The primary outcome measure is health-related quality of life (HRQL) at 36 months measured using the EQ-5D-5L. The main secondary outcome is the Glaucoma Utility Index. We plan to analyse the patient outcome data according to the group to which the patient was originally assigned. Methods of statistical analysis are described, including the handling of missing data, the covariates used in the adjusted analyses and the planned sensitivity analyses. Trial registration The trial was registered with the ISRCTN register on 23/07/2012, number ISRCTN32038223 .

Background Antifibrotic agents are commonly utilized to enhance the success rates of trabeculectomy. Novel approaches to further improve success rates and reduce the risks of complications are needed. The purpose of this study was to compare intraocular pressure (IOP)-lowering efficacy and safety of trabeculectomy or combined phacoemulsification and trabeculectomy with mitomycin-C (MMC) vs. Collagen Matrix (CM). Methods A prospective, multicenter, randomized controlled trial was performed. Ninety-five eyes of 94 patients with uncontrolled glaucoma despite medical therapy, without previous incisional glaucoma surgery underwent trabeculectomy (85 eyes) or combined phacoemulsification and trabeculectomy (10 eyes) and were randomized to MMC or CM. One eye of each subject was analyzed. Patients were followed for 24 months. The criteria for complete success were IOP >5 and ≤21 mmHg with at least a 20% reduction below medicated baseline without additional glaucoma surgery or medications. The main outcome measures were complete success rates at 24 months with Kaplan-Meier analysis and incidence of adverse events. Results The baseline IOPs were 20.4 ± 6.0 mmHg and 21.2 ± 6.1 (mean ± standard deviation, p  = 0.49) on 3.2 ± 1.1 and 3.1 ± 1.0 medications ( p  = 0.53) compared to 11.8 ± 5.2 and 12.8 ± 3.7 ( p  = 0.36) on 0.5 ± 0.8 and 0.6 ± 1.0 medications ( p  = 0.63) at 2 years in the MMC and CM groups, respectively. Kaplan-Meier analysis demonstrated complete success rates were similar in both groups at 24 months: 38.4 ± 7.6% with MMC and 56.2 ± 7.9% with CM (mean ± standard error, p  = 0.112, log rank test); however, a significantly higher incidence of failure due to persistent hypotony was observed with MMC ( p  = 0.002). Conclusions Use of the CM implant at the time of trabeculectomy or combined phacoemulsification and trabeculectomy is associated with similar complete success rates compared to adjunctive MMC; however, the risk of persistent hypotony is higher with MMC. Trial registration ClinicalTrials.gov registration number NCT01440751 . Registered 9/14/11

ObjectiveTo analyse blebs of phacotrabeculectomies performed with Ologen collagen implants (ProTop & MediKing, Taipei, Taiwan) and to compare these with blebs of mitomycin C (MMC)–augmented phacotrabeculectomies.Methods33 participants underwent phacotrabeculectomy with Ologen implants, and 33 controls underwent phacotrabeculectomy with MMC. Blebs were analysed for height and area using anterior segment optical coherence tomography (ASOCT) at 30, 60 and 90 days after surgery and were also graded clinically with the Moorfields bleb grading system (MBGS) 60 days after surgery.ResultsWith ASOCT, there was no difference in mean bleb height at 30 and 60 days, but at 90 days, bleb height was lower in the Ologen group (Ologen vs MMC, 0.74±0.20 vs 1.00±0.28 mm, p<0.001). There was no difference in mean bleb area at 30, 60 or 90 days. Mean reduction in intraocular pressure at 90 days was greater in the MMC group (Ologen vs MMC, 2.18±4.93 vs 8.00 ±7.60 mm Hg, p<0.001). At 90 days, the Ologen implants were visible in ASOCT images in 13 (39.4%) of 33 participants. With the Moorfields bleb grading system at 60 days, there was no difference in maximal bleb area score between the groups, but bleb height score was lower (Ologen vs MMC, 1.53±0.51 vs 1.81±0.59, p=0.05) and central bleb vascularity score was higher in the Ologen group (3.88±0.55 vs 2.91±0.59, p<0.001).ConclusionsWithin 3 months of surgery, mean bleb height was lower in the Ologen blebs compared with the MMC blebs. The Ologen implants had not degraded in a third of eyes.