Open Angle Glaucoma Clinical Trial
Official title:
Pressure Reduction and Medication Use Following Different Minimally Invasive Glaucoma Surgery Procedures, Prospective Randomized Clinical Trial of Efficacy
Verified date | February 2021 |
Source | Wills Eye |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 12, 2020 |
Est. primary completion date | November 12, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | 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: 1. Primary open angle glaucoma (POAG). 2. Pigmentary glaucoma. 3. 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): 1. Mild: MD no worse than -6 dB. 2. Moderate: MD worse than -6 but no worse than -12 dB. 3. Severe: MD worse than -12 dB. Exclusion Criteria: 1. Glaucoma types rather than open angle glaucoma types mentioned in the inclusion criteria (Primary, Pigmentary and Pseudoexfoliation Glaucomas). 2. Any prior glaucoma, corneal or vitreoretinal surgery. 3. Evidence of concomitant retinal, optic nerve, or neurological diseases affecting the visual field. 4. Abnormal angle anatomy. 5. Prior Argon Laser Trabeculoplasty (ALT), Laser Iridotomy or Iridoplasty. 6. Any systemic condition or medications affectiong IOP. 7. Corneal opacity, corneal dystrophy or central corneal thickness (CCT) less than 480 or more than 620 microns. 8. 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: 1. Visual Field: Mean deviation worse than -12 dB. 2. Intraocular pressure: a treated IOP of greater than 24 mmHg. 3. Medications: using more than three medications. |
Country | Name | City | State |
---|---|---|---|
United States | Wills Eye Hospital | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Wills Eye | Tanta Medical School, Tanta University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intraocular Pressure (IOP) | Reduction of IOP after eye surgery measured in millimeters of mercury (mmHg) | 1 hour examination at Baseline, Day 1, Week 1, Months 1, 3, 6 and 12 | |
Secondary | Visual Acuity | Change in visual acuity after eye surgery measured in minimal angle of resolution (logMAR). | 1 hour examination at Baseline, Day 1, Week 1, Months 1, 3, 6 and 12 | |
Secondary | Central Corneal Thickness (CCT) | Change in CCT after eye surgery measured in microns using pachymeter. | 1 hour examination at Baseline, Months 3, 6 and 12 | |
Secondary | Endothelial Cell Count | Change in endothelial cell count after eye surgery measured in number of cells by millimeter square using specular microscopy. | 1 hour examination at Baseline, Months 3, 6 and 12 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03284853 -
Safety and Efficacy Study of PG324 (Netarsudil/Latanoprost 0.02% / 0.005%) Ophthalmic Solution Compared to GANFORT® Ophthalmic Solution in Open Angle Glaucoma or Ocular Hypertension
|
Phase 3 | |
Terminated |
NCT03611530 -
CoQun Study - (COQUN): a Study to Evaluate the Effects of CoQun in Patients Affected by Open-angle Glaucoma
|
N/A | |
Not yet recruiting |
NCT06441643 -
Next Generation Rocklatan
|
Phase 2 | |
Not yet recruiting |
NCT02868502 -
Different Glaucoma Treatments Effect on Intraocular Pressure Fluctuation With Postural Change in Eyes With Open-angle Glaucoma
|
N/A | |
Completed |
NCT02272569 -
STARflo European Safety and Efficacy Study
|
N/A | |
Completed |
NCT02628223 -
180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma
|
N/A | |
Completed |
NCT01936389 -
A Prospective Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Exfoliation Syndrome and Ocular Hypertension or Glaucoma
|
Phase 2 | |
Completed |
NCT00941525 -
Central Corneal Thickness and 24-hour Fluctuation of Intraocular Pressure
|
Phase 4 | |
Completed |
NCT00539526 -
Evaluation of Hyperemia With the Use of Ocular Prostaglandin Analogues
|
Phase 4 | |
Completed |
NCT00121147 -
Additivity Study: Additive Effect on Eye Pressure of Azopt and Alphagan P to Travatan
|
N/A | |
Active, not recruiting |
NCT05035394 -
Swedish Microinvasive Glaucoma Surgery Study (SMIGS)
|
N/A | |
Completed |
NCT03450629 -
Evaluation of Safety and Efficacy of PDP-716
|
Phase 3 | |
Active, not recruiting |
NCT06061718 -
Travoprost Intraocular Implant in Conjunction With Cataract Surgery
|
Phase 3 | |
Recruiting |
NCT05241938 -
PSLT Compared to Prostaglandin Analogue Eye Drops
|
N/A | |
Completed |
NCT01342406 -
Effects of Selective Laser Trabeculoplasty on Aqueous Humor Dynamics
|
||
Completed |
NCT02250612 -
SYL040012, Treatment for Open Angle Glaucoma
|
Phase 2 | |
Completed |
NCT01937312 -
Effect of SIMBRINZA® Suspension as an Added Therapy to a Prostaglandin Analogue
|
Phase 4 | |
Terminated |
NCT01983579 -
TF (SENSIMED Triggerfish) in Intraocular Anti-VEGF (Vascular Endothelial Growth Factor) Injection
|
Phase 4 | |
Completed |
NCT01937299 -
Effect of SIMBRINZA® Suspension as an Added Therapy to TRAVATAN Z®
|
Phase 4 | |
Completed |
NCT01229982 -
A Study Evaluating the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma
|
Phase 2 |