China Glaucoma Treatment Pattern Study I-Primary Angle-Closure Glaucoma: protocol for a multicentre, retrospective, observational study

Introduction
Primary angle-closure glaucoma (PACG) is a leading cause of irreversible blindness globally, and the number of patients with PACG rises every year. Yet, there is a lack of knowledge about the clinical characteristics, therapeutic options and profile of patients with PACG in China. Hence, we design the China Glaucoma Treatment Pattern Study –Primary Angle-Closure Glaucoma (Ch-GTP). The objective of this paper is to describe the design and methodology of Ch-GTP. The aim of this study is to characterise the profile and trend associated with initial PACG treatment for the last 10 years in China.

Methods
Ch-GTP is a national multicentre retrospective observational study that will randomly sample from 50 hospitals throughout China. Over 7000 patient records hospitalised for initial PACG treatment from 2011 to 2020 will be selected randomly. The data from electronic medical records will be uploaded to an encrypted online platform that will receive and collate data from all collaborating hospitals. Data abstraction and monitoring will be performed in a standardised manner by trained statisticians to ensure consistency. Systematic data cleaning will also be conducted by statisticians to ensure data integrity before final data storage. The outcomes will include four broad categories: (1) demographics, (2) clinical characteristics, (3) therapeutic strategies and procedures and (4) early outcomes at discharge. The demographic characteristics and early outcomes will be summarised using descriptive statistics. Comparative analyses of characteristics and treatment pattern changing trends for different regions and years will be used to test for significant differences (t-test or Mann-Whitney U test).

Ethics and dissemination
The collaborating hospitals obtained local approval based on a standard ethics application from internal ethics committees or acknowledged an existent ethics approval of the leading institution with approval from internal ethics committees. Due to the retrospective nature, written informed consent from patients was waived by the ethics committee. The results will be published in academic journals and presented at national and international academic conferences.

Trial registration number
ChiCTR2100054643.

Leggi
Aprile 2023

Primary open-angle glaucoma in patients with obstructive sleep apnoea in a Colombian population: a cross-sectional study

Objective
Determine the prevalence, functional and structural alterations of primary open-angle glaucoma (POAG) in patients with obstructive sleep apnoea (OSA).

Design
Cross-sectional.

Setting
Tertiary hospital associated with specialised center in ophthalmologic images in Bogota, Colombia.

Participants
150 patients, for a sample of 300 eyes, 64 women (42.7%) and 84 men (57.3%) between 40 and 91 years old with a mean age of 66.8 (±12.1) years.

Interventions
Visual acuity, biomicroscopy, intraocular pressure, indirect gonioscopy and direct ophthalmoscopy. Patients classified as glaucoma suspects underwent automated perimetry (AP) and optical coherence tomography of the optic nerve

Outcome measure
The primary outcomes are the determination of prevalence of glaucoma suspects and POAG in patients with OSA. Secondary outcomes are the description of functional and structural alterations in computerised exams of patients with OSA.

Results
The prevalence of glaucoma suspect was 12.6%, and for POAG was 17.3%. No alterations in the appearance of the optic nerve was seen in 74.6%, focal or diffuse thinning of the neuroretinal rim (16.6%) was the most frequently finding, followed by asymmetry of the disc >0.2 mm (8.6%) (p=0.005). In the AP, 41% showed arcuate, nasal step and paracentral focal defects. The mean retinal nerve fiber layer (RNFL) was normal ( >80 µM) in 74% of the mild OSA group, 93.8% of the moderate group and 17.1% of the severe group. Similarly, normal (P5-90) ganglion cell complex (GCC) in 60%, 68% and 75%, respectively. Abnormal results in the mean RNFL was seen in 25.9%, 6.3% and 23.4% of the mild, moderate and severe groups, respectively. In the GCC, 39.7%, 33.3% and 25% of the patients in the aforementioned groups.

Conclusion
It was possible to determine the relationship between structural changes in the optic nerve and the severity of OSA. No relationship with any of the other studied variables was identified.

Leggi
Febbraio 2023

Long-term success after trabeculectomy in open-angle glaucoma: results of a retrospective cohort study

Objective
To evaluate the long-term outcomes of trabeculectomy (TE) surgery in a large cohort with a minimum follow-up of 3 years.

Design
Retrospective cohort study.

Setting
University Eye Hospital, Germany.

Participants
Three hundred and seventy-nine patients with open-angle glaucoma underwent TE with mitomycin C (MMC) between January 2013 and February 2017 with a minimal follow-up of 3 years. Eligible patients were identified via an electronic surgical case register.

Interventions
All patients had undergone TE with MMC following a set surgical protocol. To assess the influence of cataract surgery following TE, eyes which underwent cataract surgery at least 6 months after TE were matched 1:3 by sex and age to eyes who did not undergo cataract surgery during the follow-up period.

Main outcome measures
Primary outcome was the proportion of surgical success based on intraocular pressure (IOP), surgical complications, the need for revision surgery, loss of light perception and the need for additional pressure-lowering medication.

Results
The mean follow-up time was 6 (±0.8, IQR: 5.4–6.5) years. Seventy-three per cent of eyes achieved qualified surgical success at the last follow-up (IOP≥5 mm Hg and ≤18 mm Hg, without surgical complications or complete loss of vision) but necessitated additional medical therapy, complete surgical success with no additional medical therapy was achieved in 69% of eyes. There was no significant difference in the success probability between eyes that had undergone cataract surgery after TE and those that had not (p=0.45).

Conclusions
The results demonstrate a high and stable success rate of TE after a mean follow-up time of approximately 6 years, that is, not affected by later cataract surgery.

Leggi
Febbraio 2023

Association of sleep behaviour and pattern with the risk of glaucoma: a prospective cohort study in the UK Biobank

Objectives
Given the role of intraocular pressure in glaucoma, the patient’s sleeping pattern might contribute to the development and progression of glaucoma. We performed a study to understand the association between sleep behaviours and glaucoma.

Design
Our study was a prospective cohort study.

Setting
This was a prospective cohort study in the UK Biobank. Self-reported data on five sleep behaviours were collected using a questionnaire at baseline. We identified four sleep patterns based on a cluster analysis of the sleep behaviours.

Participants
In the UK Biobank, 409 053 participants were recruited between 2006 and 2010 and followed for a diagnosis of glaucoma. We identified glaucoma as any hospital admission with a diagnosis of glaucoma, based on UK Biobank inpatient hospital data. Individuals who withdrew from the UK Biobank, or were diagnosed with glaucoma before recruitment, or had self-reported surgery or laser treatment for glaucoma, or had no information on sleep behaviors were excluded.

Primary and secondary outcome measures
We estimated hazard ratios (HRs) with 95% confidence intervals (CI) using Cox proportional hazards models to estimate the associations of different sleep behaviors, as well as identified sleep patterns, with the risk of glaucoma, adjusting for multiple confounders.

Results
Compared with individuals who had a healthy sleep pattern, an excess risk of any glaucoma was observed among individuals with snoring and daytime sleepiness (HR 1.11, 95% CI 1.03 to 1.19) or insomnia and short/long sleep duration (HR 1.13, 95% CI 1.06 to 1.20), but not late chronotype sleep pattern (HR 0.98, 95% CI 0.93 to 1.03).

Conclusion
Snoring, daytime sleepiness, insomnia, and short/long duration, individually or jointly, were all associated with the risk of glaucoma. These findings underscore the need for sleep intervention for individuals at high risk of glaucoma as well as potential ophthalmologic screening among individuals with chronic sleep problems for glaucoma prevention.

Leggi
Novembre 2022

Protocol for systematic review and network meta-analysis of comparative effectiveness of surgical interventions for primary congenital glaucoma

Introduction
Primary congenital glaucoma (PCG), a type of childhood glaucoma, is primarily treated surgically to lower intraocular pressure (IOP). Failure to intervene could result in partial, or even total, blindness. Various surgical intervention types have been proposed for PCG, though the evidence on comparative effectiveness remains limited. The current protocol is an ongoing network meta-analysis enabling comparative investigation of surgical interventions for which randomised controlled trials (RCTs) are available. Our aim is to systematically compare the efficacy of various types of surgical intervention for patients with PCG.

Methods and analysis
Studies of interest will assess the effects of those surgical interventions on surgery-naïve children (age

Leggi
Settembre 2022

Quality of life in children with glaucoma: a qualitative interview study in Australia

Objective
Childhood glaucoma is a chronic vision-threatening condition that may significantly impact an individual’s psychosocial well-being. There is a paucity of literature investigating the quality of life (QoL) in children with glaucoma. The aim of this study was to investigate and report on the QoL issues encountered by children with glaucoma.

Design
This is a qualitative interview study. Data were collected through semistructured interviews. NVivo V.12 software (QSR International Pty Ltd, Melbourne, Australia) was used to analyse and code data to identify QoL themes. The prominence of QoL themes was determined by the number of children who raised issues connected to the corresponding theme.

Setting
Interviews were conducted via telephone or videoconferencing between April 2020 and July 2021.

Participants
Eighteen children with glaucoma, aged 8–17 years, who resided in Australia, were recruited from the Australian and New Zealand Registry of Advanced Glaucoma.

Results
Median child age was 12.1 years (IQR: 9.7–14.5 years) and 33% were female. Seven QoL themes were identified: ‘coping’, ‘inconveniences’ and ‘emotional well-being’ were more prominent themes than ‘symptoms’, ‘ocular health concerns’, ‘social well-being’ and ‘autonomy’. Adaptive coping strategies included resilience throughout clinical examinations and establishing positive relationships with ophthalmologists. These minimised inconveniences related to clinic waiting times and pupillary dilatation. External to the clinical setting, children often dissociated from their glaucoma but struggled with glare symptoms and feeling misunderstood by fellow peers. Older children aged 13–17 years commonly disengaged from their glaucoma care and expressed an unwillingness to attend ophthalmic appointments. Older children further raised issues with career options, obtaining a driver’s licence and family planning under the theme of autonomy.

Conclusions
The psychosocial impact of childhood glaucoma extends beyond the clinical environment and was minimised using coping strategies. Older children may require additional social and ophthalmic support as they transition into adulthood.

Leggi
Luglio 2022

Efficacy and safety of trabeculectomy versus peripheral iridectomy plus goniotomy in advanced primary angle-closure glaucoma: study protocol for a multicentre, non-inferiority, randomised controlled trial (the TVG study)

Introduction
Primary angle-closure glaucoma (PACG) is a major subtype of glaucoma that accounts for most bilateral glaucoma-related blindness globally. Filtering surgery is a conventional strategy for PACG, yet it has a long learning curve and undesirable disastrous complications. Minimally invasive glaucoma surgery (MIGS) plays an increasing role in the management of glaucoma due to its safer and faster recovery profile; cataract surgery-based MIGS is the most commonly performed such procedure in PACG. However, for patients with a transparent lens or no indications for cataract extraction, incorporation of MIGS into PACG treatment has not yet been reported. Therefore, this multicentre, non-inferiority, randomised controlled clinical trial aims to compare the efficacy and safety of trabeculectomy versus peripheral iridectomy plus an ab interno goniotomy in advanced PACG with no or mild cataracts.

Methods and analysis
This non-inferiority, multicentre, randomised controlled trial will be conducted at seven ophthalmic departments and institutes across China. Eighty-eight patients with no or mild cataracts and advanced PACG will be enrolled and randomised to undergo trabeculectomy or peripheral iridectomy plus ab interno goniotomy. Enrolled patients will undergo comprehensive ophthalmic examinations before and after surgery. The primary outcome is intraocular pressure (IOP) at 12 months postoperatively. The secondary outcomes are cumulative success rate of surgery, surgery-related complications and number of IOP-lowering medications. Participants will be followed up for 36 months postoperatively.

Ethics and dissemination
The study protocol was approved by the ethical committees of the Zhongshan Ophthalmic Center, Sun Yat-sen University, China (ID: 2021KYPJ191) and of all subcentres. All participants will be required to provide written informed consent. The results will be published in peer-reviewed journals and disseminated in international academic meetings.

Trial registration number
NCT05163951.

Leggi
Luglio 2022

Comparison of Hydrus and iStent microinvasive glaucoma surgery implants in combination with phacoemulsification for treatment of open-angle glaucoma: systematic review and network meta-analysis

Objectives
To compare the efficacy and safety of two Schlemm’s canal-based microinvasive glaucoma surgery (MIGS) devices, the Hydrus Microstent and the iStent Trabecular Bypass combined with phacoemulsification for treatment of open-angle glaucoma.

Design
Systematic review and network meta-analysis.

Methods
Literature searches were conducted on PubMed, Web of Science, Cochrane Library and ClinicalTrials.gov to identify randomised controlled trials (RCTs) assessing the Hydrus or the iStent implantation combined with phacoemulsification for treatment of open-angle glaucoma until September 2020. Risk of bias was assessed using a six-item modified Jadad scale. Effects were estimated using the intraocular pressure (IOP) reduction (IOPR), the percentage of IOPR and the proportion of medication-free patients at follow-up end. Safety was estimated using the proportions of adverse events. The network meta-analysis was conducted within a Bayesian framework using the Markov Chain Monte Carlo method in ADDIS software.

Results
Six prospective RCTs comprising 1397 patients were identified. Regarding the absolute value and the percentage of IOPR, the Hydrus and 2-iStent implantation combined with phacoemulsification were significantly more effective than phacoemulsification alone. Rank probability analysis revealed the Hydrus might be the best choice to lower IOP. There was no significant difference in the proportion of medication-free patients among groups. The Hydrus and 2-iStent implantation had a higher probability to achieve the medication-free status versus the 1-iStent implantation and phacoemulsification alone. Overall safety profiles were good for each device with the focal peripheral anterior synechiae more frequently reported in Hydrus eyes.

Conclusions
The Hydrus implantation may have a slight advantage over the 1-iStent or 2-iStent implantation in combination with phacoemulsification to treat open-angle glaucoma. Our findings might be of some uncertainty due to the limited included data. Further studies are needed to investigate whether our findings are robust, including high-quality RCTs to directly compare these MIGS devices.

Leggi
Giugno 2022