Dataset Information

Safety and Efficacy of Three Variants of Canaloplasty with Phacoemulsification to Treat Open-Angle Glaucoma and Cataract: 12-Month Follow-Up.

ABSTRACT:

Background

A single-center prospective randomized observational study to compare three types of canaloplasty, i.e., ab externo (ABeC), minicanaloplasty (miniABeC) and ab interno, (ABiC) combined with cataract surgery in primary open-angle glaucoma (POAG) patients over 12 months.

Methods

48 POAG patients underwent one of three canaloplasty procedures: ABeC (16 eyes), miniABeC (16 eyes) or ABiC (16 eyes) or combined with phacoemulsification. Patients were assessed at baseline, at day 0-1-7 and at month 1-3-6-12. Successful treatment was defined as unmedicated IOP reduction ≥20%. Complete surgical success was defined as an IOP ≤ 15 mmHg without medications, and a qualified surgical success as IOP ≤ 15 mmHg with or without medications.

Results

Pre-washout IOP median values (mmHg) were 17 (ABeC), 18 (miniABeC) and 17 (AbiC) and decreased at 12-month follow up postoperatively to 13 (p = 0.005), 13 (p = 0.004) and 14 (p = 0.008), respectively-successful treatment was achieved in approximately 100% of patients for ABeC and in 93.8% for both miniABeC and AbiC groups. Preoperatively, the median number of medications was 2.0 (range 1-3) (ABeC), 2.0 (1-3) (miniABeC) and 2.0 (0-4) (ABiC); 12-month post-operatively, all medications were withdrawn except in two patients (followed miniABeC and AbiC).

Conclusions

The three variants of canaloplasty significantly reduced IOP and the number of medications in patients with mild to moderate POAG and gave no significant complications.

SUBMITTER: Kicinska AK

PROVIDER: S-EPMC9655938 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

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Publications

Safety and Efficacy of Three Variants of Canaloplasty with Phacoemulsification to Treat Open-Angle Glaucoma and Cataract: 12-Month Follow-Up.

Kicińska Aleksandra K AK Danielewska Monika E ME Rękas Marek M

Journal of clinical medicine 20221102 21

<h4>Background</h4>A single-center prospective randomized observational study to compare three types of canaloplasty, i.e., ab externo (ABeC), minicanaloplasty (miniABeC) and ab interno, (ABiC) combined with cataract surgery in primary open-angle glaucoma (POAG) patients over 12 months.<h4>Methods</h4>48 POAG patients underwent one of three canaloplasty procedures: ABeC (16 eyes), miniABeC (16 eyes) or ABiC (16 eyes) or combined with phacoemulsification. Patients were assessed at baseline, at da ...[more]

PMID: 36362728

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Project description:PurposeTo report 12-month efficacy outcomes of 360° canaloplasty and 180° trabeculotomy using the OMNI surgical system in combination with phacoemulsification in patients with mild-moderate open-angle glaucoma (OAG) and visually significant cataract.SettingFifteen multi-subspecialty ophthalmology practices and surgery centers located in 14 US states.DesignProspective, multicenter, IRB approved study of patients treated with canaloplasty (360°) and trabeculotomy (180°). Eligible patients had cataract and mild-moderate OAG with intraocular pressure (IOP) ≤33 mmHg on 1 to 4 hypotensive medications. Unmedicated post-washout mean diurnal IOP (DIOP) ≥21 and ≤36 mmHg.MethodsMedication washout preoperatively and prior to month 12 DIOP. Effectiveness outcomes were IOP and IOP lowering medication use. Safety outcomes included adverse events and secondary surgical interventions (SSIs). Evaluations at 1, 3, 6, and 12 months.ResultsA total of 149 subjects underwent surgery and 120 were included in the final effectiveness analysis. Mean (standard deviation) unmedicated diurnal IOP was reduced from 23.8 (3.1) mmHg at baseline to 15.6 (4.0) at month 12 (-35%) and medications (before washout) were reduced from 1.8 (0.9) at baseline to 0.4 (0.9) at month 12 (-80%). At month 12, 84.2% of eyes achieved IOP reductions >20% from baseline, 80% of eyes were medication-free, and 76% of eyes achieved IOP between 6-18 mmHg inclusive. Adverse events were uncommon. Most were mild and self-limited including transient hyphema (9 of 149; 6%) and transient IOP elevations (3 of 149; 2.0%). No eyes required SSIs or experienced loss of VA that was attributable to the device or procedure.ConclusionCanaloplasty and trabeculotomy performed with the OMNI surgical system at the time of phacoemulsification significantly reduces unmedicated mean diurnal IOP and medication use 12 months postoperatively, with an excellent safety profile. This procedure should be considered for eyes with mild-moderate OAG to reduce IOP, medication burden, or both.

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Dataset Information

Safety and Efficacy of Three Variants of Canaloplasty with Phacoemulsification to Treat Open-Angle Glaucoma and Cataract: 12-Month Follow-Up.

Background

Methods

Results

Conclusions

Publications

Safety and Efficacy of Three Variants of Canaloplasty with Phacoemulsification to Treat Open-Angle Glaucoma and Cataract: 12-Month Follow-Up.

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