An interventional study of Glaucoma and Cataract Surgery in Open Angle Glaucoma, Primary Open Angle Glaucoma and Pigmentary Glaucoma, sponsored by Wills Eye. Withdrawn at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2021-02-21.
Sponsored by Wills Eye · Not applicable, Interventional, and Treatment
The primary objective of this research is to compare the efficacy of trabecular minimally invasive glaucoma surgery (MIGS) devices (iStent vs iStent Inject vs Hydrus) for intra ocular pressure (IOP) and anti-glaucoma medication reduction in open angle glaucoma.
Study Design Prospective Randomized Clinical Trial (Parallel Group Study)
Patients who fit inclusion criteria will be randomly assigned to one of the 3 parallel groups (one of the study surgical interventions combined with phacoemulsification) in the following order:
Preoperative Evaluation of : Visual acuity, Slit lamp examination, IOP, Gonioscopy, Fundus Examination, Central corneal thickness (CCT), Endothelial Cell Count (ECC), Visual field, Retinal Nerve Fiber layer (RNFL) thickness by Optical Coherence Tomography (OCT) and Number and type of preoperative antiglaucoma medications.
Patients will be followed postoperatively at Day 1, Week 1, Months 1, 3, 6 and 12.
Medication Washout will be done at baseline, Months 6 and 12 to evaluate non-medicated IOP.
The duration of washout will be:
4 Weeks for Prostaglandin Analogues (PGA) and Beta Blockers (BB). 2 Weeks for Carbonic Anhydrase Inhibitors (CAI) and Alpha Agonists (AA).
The IOP measurements in the wash out visits:
will be performed according to 2-operator method to provide masking as described in Ocular Hypertension Treatment Study (OHTS) and Glaucoma World Association Guidelines.
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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:
Pseudoexfoliative glaucoma. 4. Patients should be candidate for safe mediaction wash out in the opinion of the investigator.
The severity of glaucoma is classified using the Hodapp Parrish Anderson Visual Field Criteria depending on the Mean Deviation (MD):
Exclusion Criteria:
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:
iStent Trabecular Bypass Device (to lower intraocular pressure) combined with Phacoemulsification (to remove cataract and insert intraocular lens) Eye Surgery
Procedure: Glaucoma and Cataract Surgery
iStent Inject Trabecular Bypass Device (to lower intraocular pressure) combined with Phacoemulsification (to remove cataract and insert intraocular lens) Eye Surgery
Procedure: Glaucoma and Cataract Surgery
Hydrus Trabecular Bypass Device (to lower intraocular pressure) combined with Phacoemulsification (to remove cataract and insert intraocular lens) Eye Surgery
Procedure: Glaucoma and Cataract Surgery
Patients requiring combined cataract and glaucoma surgery will be randomized to either iStent, iStent Inject or Hydrus (to lower intraocular pressure) combined with Phacoemulsification (to remove cataract and insert intraocular lens) Eye Surgery
Intraocular Pressure (IOP)
Reduction of IOP after eye surgery measured in millimeters of mercury (mmHg)
Time frame: 1 hour examination at Baseline, Day 1, Week 1, Months 1, 3, 6 and 12
Visual Acuity
Change in visual acuity after eye surgery measured in minimal angle of resolution (logMAR).
Time frame: 1 hour examination at Baseline, Day 1, Week 1, Months 1, 3, 6 and 12
Central Corneal Thickness (CCT)
Change in CCT after eye surgery measured in microns using pachymeter.
Time frame: 1 hour examination at Baseline, Months 3, 6 and 12
Endothelial Cell Count
Change in endothelial cell count after eye surgery measured in number of cells by millimeter square using specular microscopy.
Time frame: 1 hour examination at Baseline, Months 3, 6 and 12
Plan to share: No
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This study is withdrawn, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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