IOP and Medication Reduction in MIGS Procedures
Open Angle Glaucoma, Primary Open Angle Glaucoma, Pigmentary Glaucoma
About this trial
This is an interventional treatment trial for Open Angle Glaucoma
Eligibility Criteria
Inclusion Criteria:
1. Adult male or female aged 40 years or more. 2. Patients able and willing to provide informed consent. 3. Patients having Visually Significant Age Related Cataract with Mild to Moderate Open Angle Glaucoma (OAG) on topical anti-glaucoma medication with or without previous Selective Laser Trabeculoplasty (SLT) ), including:
- Primary open angle glaucoma (POAG).
- Pigmentary glaucoma.
Pseudoexfoliative glaucoma. 4. Patients should be candidate for safe mediaction wash out in the opinion of the investigator.
- The diagnosis of glaucoma is confirmd by optic nerve examination and the characteristic visual field defects on automated perimetry according to the American Academy of Ophthalmology (AAO) Definition and Criteria.
The severity of glaucoma is classified using the Hodapp Parrish Anderson Visual Field Criteria depending on the Mean Deviation (MD):
- Mild: MD no worse than -6 dB.
- Moderate: MD worse than -6 but no worse than -12 dB.
- Severe: MD worse than -12 dB.
Exclusion Criteria:
- Glaucoma types rather than open angle glaucoma types mentioned in the inclusion criteria (Primary, Pigmentary and Pseudoexfoliation Glaucomas).
- Any prior glaucoma, corneal or vitreoretinal surgery.
- Evidence of concomitant retinal, optic nerve, or neurological diseases affecting the visual field.
- Abnormal angle anatomy.
- Prior Argon Laser Trabeculoplasty (ALT), Laser Iridotomy or Iridoplasty.
- Any systemic condition or medications affectiong IOP.
- Corneal opacity, corneal dystrophy or central corneal thickness (CCT) less than 480 or more than 620 microns.
Exclusion from medications wash out according to the opinion of the investigator Or if any of the following is observed at any time point of the study:
- Visual Field: Mean deviation worse than -12 dB.
- Intraocular pressure: a treated IOP of greater than 24 mmHg.
- Medications: using more than three medications.
Sites / Locations
- Wills Eye Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
iStent
iStent Inject
Hydrus
iStent Trabecular Bypass Device (to lower intraocular pressure) combined with Phacoemulsification (to remove cataract and insert intraocular lens) Eye Surgery
iStent Inject Trabecular Bypass Device (to lower intraocular pressure) combined with Phacoemulsification (to remove cataract and insert intraocular lens) Eye Surgery
Hydrus Trabecular Bypass Device (to lower intraocular pressure) combined with Phacoemulsification (to remove cataract and insert intraocular lens) Eye Surgery