Feasibility, efficacy and safety of early lens extraction in patients with pseudoexfoliation glaucoma: a feasibility and pilot study

PURPOSE: To evaluate the feasibility of a trial to compare the efficacy and safety of initial lens extraction surgery versus medical treatment for people with pseudoexfoliation glaucoma (PXFG) or ocular hypertension (OHT) and pseudoexfoliation syndrome. METHODS: This is a feasibility and pilot randomized controlled trial (RCT) in patients with newly diagnosed PXFG and mild cataract. The study was prospectively registered at ClinicalTrials.gov. An online survey was conducted among members of UK and Eire Glaucoma Society (UKEGS) and Spanish Glaucoma Society (SEG) with the aim of understanding current practices related to interventions for PXFG, the role of phacoemulsification and the willingness to participate in a definite trial. Participants were randomized into either early lens extraction surgery or medical treatment and deferred surgery Primary clinical outcome was intraocular pressure (IOP) at 12 months. RESULTS: The study was conducted between May 2019 and February 2021. Twelve patients were randomized, six in each group. Median IOP decreased significantly in both arms. Among the secondary outcomes of BVCA, reduction in the number of treatments and quality of life, statistically significant differences were found in favor of lens extraction. There were no differences in other secondary outcomes. No adverse effects occurred. Glaucoma experts would be willing to participate in a RCT. CONCLUSIONS: A trial on early lens extraction surgery compared with medication in PXFG is feasible. Early lens extraction appears to be an effective treatment for PXFG, reducing the number of hypotensive drugs after surgery as well as improving patients’ quality of life

Surgical and laser interventions for pseudoexfoliation glaucoma systematic review of randomized controlled trials

To assess the comparative effectiveness and safety of different surgical and laser techniques in people with pseudoexfoliation glaucoma (PXFG). We conducted a systematic review including randomized controlled trials (RCT) that compared any pair of surgical or laser treatment versus other type of intervention in PXFG. RCT were identified by a highly sensitive search of electronic databases and two individuals independently assessed trial eligibility, abstracted data and assessed risk of bias. We performed Bayesian Meta-Analysis when outcomes were comparable. The search strategy identified 6171 records. Six studies (262 subjects) were included. Two trials analyzed the same pair of surgical interventions comparing phacoemulsification as solo procedure or combined with trabecular aspiration and we performed meta-analysis. Other RCTs compared the following interventions: trabecular aspiration associated with phacoemulsification versus phacotrabeculectomy, non-penetrating deep sclerectomy associated or not with phacoemulsification, selective versus argon laser trabeculoplasty and one-site versus two-site phacotrabeculectomy. For IOP data, none of the trials reported a difference between pairs of surgical techniques, nor changes in visual acuity or number of post-operative medications. The overall risk of bias is moderate to high. There are no apparent differences in efficacy and safety, although with large uncertainty, between surgical or laser techniques for PXFG. Based on the low-quality evidence from the six studies included in this review, it is not possible to justify the preferential use of non-penetrating surgery, MIGS or trabecular aspiration (with or without cataract surgery) in PXFG. Further research is needed to determine the optimal management of this condition