An observational study in Primary Open-Angle Glaucoma, sponsored by Mann Eye Institute. Not yet recruiting at 1 site in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Mann Eye Institute · Observational
This study is a single center, ambispective study of visual outcomes after successful bilateral cataract surgery in patients with mild to moderate primary open-angle glaucoma (POAG). Two cohorts are compared: patients with bilateral implantation of the TECNIS PureSee non-diffractive extended depth of focus intraocular lens (EDOF IOL) and patients with bilateral implantation of the TECNIS ZCB00 monofocal IOL.
924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.
This study's planned enrollment of 100 is close to the median of 101 across 184 observational studies indexed under Glaucoma, Open-Angle.
Browse Glaucoma, Open-Angle studies →Mann Eye Institute is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients aged 45 years and older who underwent bilateral cataract surgery with bilateral implantation of either PureSee EDOF or TECNIS ZCB00, with bilateral mild or moderate primary open-angle glaucoma.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age ≥45 years. Prior bilateral cataract surgery with bilateral implantation of either PureSee EDOF or TECNIS ZCB00 on or after March 12, 2026.
Intended postoperative refractive target between plano and -0.50 D in each eye. No intentional monovision. Bilateral mild or moderate POAG according to AAO ICD-10 staging criteria. Reliable glaucoma visual field available within approximately 18 months before cataract surgery or study enrollment, when available.
Reliable optical coherence tomography examination within 6 months. Adequately controlled IOP and clinically stable glaucoma in the investigator's opinion.
Prior SLT is permitted. Concurrent MIGS at the time of cataract surgery is permitted when clinically indicated at the discretion of the treating surgeon.
Ability to complete the study-specific examination and questionnaires. Study visit occurring 3-18 months following second-eye cataract surgery.
Exclusion Criteria:
Severe POAG or glaucomatous visual field loss involving fixation. Secondary glaucoma, including pseudoexfoliative, pigmentary, angle-closure, neovascular, or uveitic glaucoma.
Glaucoma surgery other than eligible concurrent MIGS that may materially influence study outcomes.
Corneal pathology or irregular astigmatism affecting visual outcomes. Prior corneal refractive surgery. Macular or neuro-ophthalmic disease affecting visual function. Other ocular pathology expected to limit postoperative CDVA to worse than 20/30.
Inability to obtain reliable visual field testing when required for glaucoma characterization.
Intentional monovision. The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
Subjects with bilateral implantation of the TECNIS PureSee Intraocular Lens (toric and non-toric) at cataract surgery.
Device: TECNIS PureSee Intraocular Lens
Subjects with bilateral implantation of the TECNIS Monofocal Intraocular Lens ZCB00 (toric and non-toric) at cataract surgery.
Device: TECNIS ZCB00 Monofocal Intraocular Lens
Bilateral implantation of the TECNIS PureSee non-diffractive extended depth of focus intraocular lens (toric and non-toric) at cataract surgery.
Bilateral implantation of the TECNIS Monofocal Intraocular Lens ZCB00 (toric and non-toric) at cataract surgery.
Distance visual acuity - binocular distance-corrected visual acuity (DCVA)
Binocular distance-corrected visual acuity measured at the single study visit occurring 3 to 18 months following second-eye cataract surgery.
Time frame: 3 to 18 months following second-eye cataract surgery
Intermediate visual acuity - binocular distance-corrected intermediate visual acuity (DCIVA)
Binocular distance-corrected intermediate visual acuity at 66 cm measured at the single study visit occurring 3 to 18 months following second-eye cataract surgery.
Time frame: 3 to 18 months following second-eye cataract surgery
Contrast sensitivity - binocular, distance-corrected, photopic CSV-1000 contrast sensitivity without glare
CSV-1000 contrast sensitivity at spatial frequencies of 3, 6, 12, and 18 cycles per degree, binocular, distance-corrected, photopic, without glare.
Time frame: 3 to 18 months following second-eye cataract surgery
Spectacle independence at distance, intermediate, and near
Patient-reported spectacle independence at distance, intermediate, and near.
Time frame: 3 to 18 months following second-eye cataract surgery
Quality of vision and dysphotopsias
Patient-reported quality of vision and dysphotopsias assessed with validated patient-reported outcome instruments including the AIOLIS Questionnaire.
Time frame: 3 to 18 months following second-eye cataract surgery
Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) Questionnaire
The AIOLIS has 37 questions about symptoms, perceptions of general vision, and frequency of wearing glasses or contact lenses. Perceptions about general vision are asked on a 5 item scale (Poor, Fair, Good, Very good, Excellent). Poor is considered a worse outcome.
Time frame: 3 to 18 months following second-eye cataract surgery
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Oct 2027, 10 months later.
Of 53 observational studies under Glaucoma, Open-Angle, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12. This study's planned 10 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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