Abstract
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.
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.
| Original language | English |
|---|---|
| Number of pages | 7 |
| Journal | Eye |
| Early online date | 26 Sept 2022 |
| DOIs | |
| Publication status | Early online date - 26 Sept 2022 |