Trial · NCT07907055
PAUL® Glaucoma Implant Safety and Effectiveness Study
NCT07907055, Not applicable, Not yet recruiting, Clinical Research Consultants, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PAUL® Glaucoma Implant Safety and Effectiveness Study. Trials, record NCT07907055. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07907055
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PAUL® Glaucoma Implant Safety and Effectiveness Study
- NCT number
- NCT07907055
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 65 participants, estimated
- Lead sponsor
- Clinical Research Consultants, Inc.
- Conditions
- Refractory Glaucoma
- Interventions
- PAUL® Glaucoma Implant
- First posted
- 2026-10-30
- Last updated
- 2026-10-30
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07907055
GET https://conductscience.org/api/trials/v1/NCT07907055/registered