PureSee EDOF Versus ZCB00 Monofocal IOLs in Mild-to-Moderate Glaucoma
Clinical Outcomes, Contrast Sensitivity, and Patient Satisfaction Following Bilateral PureSee EDOF Versus ZCB00 Monofocal IOL Implantation in Patients With Mild to Moderate Primary Open-Angle Glaucoma: An Ambispective Investigator-Initiated Trial
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Melissa Hamann Wright, Study Staff
- Telefonnummer: 2389 713-580-2500
- E-post: Melissa.Wright@manneye.com
Studieorter
-
-
Texas
-
Houston, Texas, Förenta staterna, 77004
- Mann Eye Institute
-
Kontakt:
- Melissa Hamann Wright
- Telefonnummer: 2389 713-580-2500
- E-post: Melissa.Wright@manneye.com
-
Huvudutredare:
- Phillip Brunson, OD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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.
Beskrivning
Inclusion Criteria:
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
PureSee EDOF IOL cohort
Subjects with bilateral implantation of the TECNIS PureSee Intraocular Lens (toric and non-toric) at cataract surgery. |
Bilateral implantation of the TECNIS PureSee non-diffractive extended depth of focus intraocular lens (toric and non-toric) at cataract surgery. |
|
TECNIS ZCB00 monofocal IOL cohort
Subjects with bilateral implantation of the TECNIS Monofocal Intraocular Lens ZCB00 (toric and non-toric) at cataract surgery. |
Bilateral implantation of the TECNIS Monofocal Intraocular Lens ZCB00 (toric and non-toric) at cataract surgery. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Distance visual acuity - binocular distance-corrected visual acuity (DCVA)
Tidsram: 3 to 18 months following second-eye cataract surgery
|
Binocular distance-corrected visual acuity measured at the single study visit occurring 3 to 18 months following second-eye cataract surgery. |
3 to 18 months following second-eye cataract surgery
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Intermediate visual acuity - binocular distance-corrected intermediate visual acuity (DCIVA)
Tidsram: 3 to 18 months following second-eye cataract surgery
|
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. |
3 to 18 months following second-eye cataract surgery
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Contrast sensitivity - binocular, distance-corrected, photopic CSV-1000 contrast sensitivity without glare
Tidsram: 3 to 18 months following second-eye cataract surgery
|
CSV-1000 contrast sensitivity at spatial frequencies of 3, 6, 12, and 18 cycles per degree, binocular, distance-corrected, photopic, without glare. |
3 to 18 months following second-eye cataract surgery
|
|
Spectacle independence at distance, intermediate, and near
Tidsram: 3 to 18 months following second-eye cataract surgery
|
Patient-reported spectacle independence at distance, intermediate, and near. |
3 to 18 months following second-eye cataract surgery
|
|
Quality of vision and dysphotopsias
Tidsram: 3 to 18 months following second-eye cataract surgery
|
Patient-reported quality of vision and dysphotopsias assessed with validated patient-reported outcome instruments including the AIOLIS Questionnaire. |
3 to 18 months following second-eye cataract surgery
|
|
Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) Questionnaire
Tidsram: 3 to 18 months following second-eye cataract surgery
|
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. |
3 to 18 months following second-eye cataract surgery
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Phillip Brunson, OD, Mann Eye Institute
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PB-26-02
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