Health Condition 1: null- Unilateral Glaucoma in Sighted and Unsighted Patients
Conditions
Interventions
Intervention1: LASER: STEAM delivery device operates as a continuous wave infra-red laser is scanned over a thermally stabilized sclera to create a precise (i.e., pre-programmed) subsurface annular sh
Sponsors
Aleyegn Technologies LLC
Eligibility
Inclusion criteria
Inclusion criteria: • Male and female subjects are eligible for the study if they are 18 years old or older and have given informed consent • Have moderate to severe glaucoma (24 mm Hg to 45 mm Hg IOP) with or without visual field damage • Have primary open angle glaucoma, angle closure glaucoma, ocular hypertension, secondary glaucoma, previous intraocular surgery • Are able to follow up for one year • Able to provide written informed consent
Exclusion criteria
Exclusion criteria: • Patients younger than 18 years or older than 80 years • Patients not willing to participate in the study • Patients having Vernal Keratoconjunctivitis • Corneal Scar / corneal dystrophy / corneal degeneration • Inflammatory conditions • Patients with corneal hydrops • Patients with Diabetes, Thyroid Dysfunction, Collagen-Vascular Disorders, Auto-Immune Disorders; Hypertensives can be included provided there would be no change in the systemic treatment during the study period • Patients not able to come for follow up • Ultrasonic pachymetry • Eyes with any ocular surface infection • Endothelial cell count
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accommodative amplitude change from pre-Op on Binocular Auto-refractor (Grand Seiko 5500) Timepoint: Pre-Op (-30 days). Day of surgery (Day 0), Post-Op: Day 1, Week 1, Month 1, Month 3, Month 6, and Month 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Best spectacle-corrected Visual Acuity (BSCVA)Timepoint: Pre-Op (-30 days). Day of surgery (Day 0), Post-Op: Day 1, Week 1, Month 1, Month 3, Month 6, and Month 12.;ComplicationsTimepoint: Pre-Op (-30 days). Day of surgery (Day 0), Post-Op: Day 1, Week 1, Month 1, Month 3, Month 6, and Month 12.;Defocus Curve (iTracey)Timepoint: Pre-Op (-30 days). Day of surgery (Day 0), Post-Op: Day 1, Week 1, Month 1, Month 3, Month 6, and Month 12.;Intraocular pressure (Goldmann applanation)Timepoint: Pre-Op (-30 days). Day of surgery (Day 0), Post-Op: Day 1, Week 1, Month 1, Month 3, Month 6, and Month 12.;Manifest refraction (Phoropter)Timepoint: Pre-Op (-30 days). Day of surgery (Day 0), Post-Op: Day 1, Week 1, Month 1, Month 3, Month 6, and Month 12.;Need for adjunctive surgeryTimepoint: Pre-Op (-30 days). Day of surgery (Day 0), Post-Op: Day 1, Week 1, Month 1, Month 3, Month 6, and Month 12.;Uncorrected Visual Acuity (UCVA)Timepoint: Pre-Op (-30 days). Day of surgery (Day 0), Post-Op: Day 1, Week 1, Month 1, Month 3, Month 6, and Month 12.;UNVA (Jaeger chart)Timepoint: Pre-Op (-30 days). Day of surgery (Day 0), Post-Op: Day 1, Week 1, Month 1, Month 3, Month 6, and Month 12. | — |
Countries
India
Contacts
Public ContactDr Sirisha Senthil
LV Prasad Eye Institute
Outcome results
None listed