Trial · NCT07907055
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Subjects Achieving ≥20% Reduction in Mean Diurnal Intraocular Pressure (DIOP) | Baseline to 12 months postoperatively | Proportion of subjects achieving a ≥20% reduction in mean DIOP from baseline at 12 months postoperatively while using the same or fewer glaucoma medication classes compared with baseline. |
| Primary | Percentage Change in Mean Diurnal Intraocular Pressure (DIOP) From Baseline | Baseline to 12 months postoperatively | Percentage change in mean DIOP from baseline to 12 months postoperatively following implantation of the PAUL® Glaucoma Implant. |
| Primary | Proportion of Subjects With Loss of ≥2 Lines of Corrected Distance Visual Acuity (CDVA) | Baseline to 12 months postoperatively | Proportion of subjects experiencing a loss of two or more lines (≥10 letters) of CDVA from baseline at 12 months postoperatively. |
| Primary | Proportion of Subjects Requiring PAUL® Glaucoma Implant Removal | Through 12 months postoperatively | Proportion of subjects requiring surgical removal of the PAUL® Glaucoma Implant at or before 12 months postoperatively. |
| Secondary | Proportion of Subjects Achieving Target DIOP Range | Baseline to 12 months | Proportion of subjects with mean DIOP between 6 and 18 mmHg and a ≥20% reduction from baseline at 12 months postoperatively. |
| Secondary | Change in Number of Ocular Hypotensive Medication Classes | Baseline to 12 months | Mean change in the number of ocular hypotensive medication classes used from baseline to 12 months postoperatively. |
| Secondary | Incidence of Ocular Adverse Events | Through 12 months | Number and proportion of subjects experiencing ocular adverse events and procedure-related complications following implantation of the PAUL® Glaucoma Implant. |
| Secondary | Incidence of Elevated Intraocular Pressure Complications | Through 12 months | Proportion of subjects experiencing protocol-defined postoperative IOP complications, including IOP increases requiring medical or surgical management and IOP spikes greater than 35 mmHg at 3 months or later. |
| Other | Incidence of Lens Opacity Changes | using the Lens Opacities Classification System III (LOCS III) in phakic eyes. Baseline to 12 months | Changes Incidence of new or worsening lens opacities assessed using the Lens Opacities Classification System III (LOCS III) in phakic eyes. |
| Other | Change in Mean DIOP by Medication Status | Baseline to 12 months | Change in mean DIOP from baseline, stratified by subjects using the same or fewer versus a greater number of glaucoma medications postoperatively. |
| Other | Time to Glaucoma-Related Secondary Surgical Intervention | Through 12 months | Kaplan-Meier analysis of time to glaucoma-related secondary surgical intervention, with or without device explantation. |
| Other | Time to Device Explantation | Through 12 months | Kaplan-Meier analysis of time to surgical removal of the PAUL® Glaucoma Implant. |
| Other | Time to Treatment Failure | Through 12 months | Kaplan-Meier analysis of treatment failure, defined according to the protocol as not achieving a ≥20% reduction in DIOP from baseline on the same or fewer glaucoma medications at 12 months. |
| Other | Change in Patient-Reported Symptoms (SHPC-18) | Baseline to 12 months | Change from baseline in patient-reported symptoms measured using the Symptom Health Problem Checklist (SHPC-18). |
| Other | Change in Vision-Related Quality of Life (VFQ-25) | Baseline to 12 months | Change from baseline in vision-related quality of life measured using the 25-item Visual Function Questionnaire (VFQ-25). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT07907055/registered