A Randomized Clinical Trial Comparing Visual Outcomes And Patient Satisfaction After Bilateral Implantation Of A Prof-Ex Iol Versus A Monofocal Iol In Patients With Mild To Moderate Glaucoma And Bilateral Cataract.
Published 2026 - 44th Congress of the ESCRS
Reference: POCAT355 | Type: Poster | DOI: 10.82333/4qsq-br84
Authors: Dr Idoia Goñi-Guarro* 1 , Dr Merce Guarro 2 , Dr Marc Biarnés 3 , A/Prof. Sorcha Ní Dhubhghaill 4
1Ophthalmology,OMIQ Institute,Sant Cugat,Spain;Ophthalmology,Hospital General de Granollers,Granollers,Spain;Medicine and Pharmacy,Vrije Universiteit Brussel (VUB),Brussels,Belgium, 2Ophthalmology,OMIQ Institute,Sant Cugat,Spain;Ophthalmology,Hospital General de Granollers,Granollers,Spain, 3Research,OMIQ Institute,Sabadell,Spain, 4Ophthalmology,Universitair Ziekenhuis Brussel (UZ Brussel),Brussels,Belgium;Medicine and Pharmacy,Vrije Universiteit Brussel (VUB),Brussels,Belgium
Purpose
To evaluate and compare visual performance, patient‑reported satisfaction, and safety after bilateral implantation of an extended‑range‑of‑focus (PRoF‑Ex) intraocular lens (IOL) versus a monofocal IOL in patients with mild‑to‑moderate primary open‑angle glaucoma (POAG) and bilateral cataract, to determine whether extended‑range lenses provide superior functional vision and ocular safety and may be a viable option for this patients.
Setting
Academic clinical research center in Catalonia (Spain); recruitment of adult patients with bilateral cataract and mild to moderate POAG
Methods
A prospective, randomized, double‑blind interventional trial will randomize 74 patients (1:1) to bilateral PRoF‑Ex (Clareon Vivity®) or Clareon monofocal® IOL implantation for mild‑moderate glaucoma undergoing bilateral cataract surgery.Assessments preoperatively and through 3 months include uncorrected and corrected distance, intermediate, and near visual acuities (mono/binocular), defocus curve, photopic/mesopic contrast sensitivity, automated perimetry, macular and peripapillary imaging, aberrometry, halo metrics and questionnaires on visual function and spectacle independence (PRSIQ,CATQUEST,QUVID).Primary outcome:bDCIVA at 3 months.Trial powered 90% (n=74);primary analysis: independent‑samples t‑test; secondary/safety analyses per SAP.
Results
If hypotheses are confirmed, the PRoF‑Ex group would demonstrate superior corrected binocular intermediate visual acuity (bDCIVA) at 3 months versus the monofocal group, increased intermediate and functional near spectacle independence, and no clinically meaningful reduction in contrast sensitivity or increase in dysphotopsia. Secondary analyses would assess refractive accuracy, defocus curves, objective and subjective visual quality, and potential impacts on visual field and retinal imaging metrics. Interim data will be reported.
Conclusions
If results are confirmed, PRoF-Ex IOL may offer a viable option for selected patients with early to moderate POAG seeking greater spectacle independence after cataract surgery, by improving intermediate vision without substantial compromise in contrast sensitivity or ocular safety. Findings may inform individualized IOL selection in glaucoma patients.