N/A
Completed N=52
Treatment Outcomes of MicroPulse Trans-scleral Cyclophotocoagulation in Uncontrolled Glaucoma
Glaucoma · Glaucoma, Open-Angle · Glaucoma, Neovascular · Glaucoma and Ocular Hypertension
Source: ClinicalTrials.gov NCT03187418 ↗
Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: Intraocular Pressure (IOP) — 15.2 millimeters of mercury (mm Hg)
Summary
The goal of this study is to evaluate the efficacy and safety of the novel form of trans-scleral cyclophotocoagulation using micropulse diode laser and trans-pars plana treatment (Micropulse TSCPC, mTSCPC MP3, IRIDEX CYCLO G6™ Glaucoma Laser System, CA, USA) in adults for the treatment of uncontrolled glaucoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraocular Pressure (IOP) |
18.2; 19.2; 18.6; 17.9; 16.7 | — |
| SECONDARY Intraocular Pressure (IOP) |
18.2; 19.2; 18.6; 17.9; 16.7 | — |
| SECONDARY Number of Participants With Repeat Treatments |
10 | — |
| SECONDARY Number of Intraocular Pressure Lowering Medications |
3.5; 3.4; 3.4; 3.4; 3.2; 3.2 | — |
| SECONDARY Corrected Distance Visual Acuity (CDVA) |
0.81; 0.84; 0.79; 0.77; 0.79; 0.82 | — |
| SECONDARY Cup-to-disc Ratio (CDR) |
0.82 | — |
| SECONDARY Visual Field Index (VFI) |
57 | — |
| SECONDARY Mean Deviation (MD) |
-15.16 | — |
| SECONDARY Pattern Standard Deviation (PSD) |
7.87 | — |
| SECONDARY Average Retinal Nerve Fiber Layer (RNFL) Thickness |
62 | — |
| SECONDARY Average Ganglion Cell Layer (GCL) Thickness |
53 | — |
| SECONDARY Cup-to-disc Ratio (CDR) Assessed by Optical Coherence Tomography (OCT) |
0.82 | — |
| SECONDARY Pain Level During Laser Treatment |
34; 12; 6; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients of either sex and any race aged 18 years old and above.
- Followed by a glaucoma subspecialist at University of Montreal Hospital Center.
- Intraocular pressure (IOP) above target and unresponsive to maximal tolerated medical therapy with or without previous surgical intervention.
- mild glaucoma: IOP > 18 mmHg
- moderate glaucoma: IOP > 15 mmHg
- advanced glaucoma: IOP > 12 mmHg
- Considered poor candidates for additional filtering surgery or implantation of glaucoma drainage devices.
Exclusion Criteria
- Patients unable to give informed consent.
- Patients with significant scleral thinning, defined as thinning of more than one clock hour noticed on scleral transillumination.
- Ocular infection or inflammation in the study eye in the 2 months prior to enrolment.
- Intraocular surgery in the study eye in the 2 months prior to enrolment.
Data sourced from ClinicalTrials.gov (NCT03187418). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.