Comparing Refractive and Visual Outcomes of MIGS and Traditional Surgeries
NCT ID: NCT03584958
Last Updated: 2022-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
150 participants
OBSERVATIONAL
2018-08-01
2023-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparative Effectiveness of Treatment Strategies for Primary Open-Angle Glaucoma
NCT01645319
Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS®) to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy
NCT06313749
Advanced Glaucoma Intervention Study (AGIS)
NCT00000148
Minimally Invasive Micro Sclerostomy: Performance and Safety Evaluation Study
NCT04503590
Assessment of Effectiveness Ex-Press Surgery Modification
NCT03800589
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The advent of minimally invasive glaucoma surgery (MIGS) procedures further highlights the importance of studying refractive outcomes as many of these surgeries are being performed earlier in the glaucoma severity spectrum where central visual potential is still preserved. Furthermore, this class of surgeries is often performed in combination with cataract surgery.
There remains a lack of data regarding refractive outcomes in patients who have had phaco-iStent, phaco-Cypass, as well as goniotomy (Kahook dual blade (KDB) gonioscopy assisted transluminal trabeculotomy), and Xen gel stent implantation with or without cataract surgery. This information would help during pre-operative patient discussions and lens selection in the context of a combined procedure.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ab interno goniotomy surgery
Gonioscopy-assisted transluminal trabeculotomy (GATT) surgery to decrease intraocular pressure.
No interventions assigned to this group
Gelatin stent surgery
Subconjunctival stent (Xen) surgery to decrease intraocular pressure.
No interventions assigned to this group
Suprachoroid stent and cataract surgery
Suprachoroidal stent (Cypass) to decrease intraocular pressure in combination with cataract surgery.
No interventions assigned to this group
Trabeculectomy surgery
Glaucoma filtering surgery to decrease intraocular pressure.
No interventions assigned to this group
Cataract surgery
Cataract surgery with no glaucoma procedure.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Ab interno goniotomy surgery: Gonioscopy-assisted transluminal trabeculotomy (GATT) surgery to decrease intraocular pressure.
* Gelatin stent surgery: Subconjunctival stent (Xen) surgery to decrease intraocular pressure.
* Suprachoroidal stent and cataract surgery: Suprachoroidal stent (Cypass) to decrease intraocular pressure in combination with cataract surgery.
* Trabeculectomy surgery: Glaucoma filtering surgery to decrease intraocular pressure.
* Cataract surgery: Cataract surgery with no glaucoma procedure.
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Allergan
INDUSTRY
The American Society of Cataract and Refractive Surgery Foundation
OTHER
Wills Eye
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Daniel Lee, MD
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Daniel Lee, MD
Role: PRINCIPAL_INVESTIGATOR
Wills Eye Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Wills Eye Hospital
Philadelphia, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
18-689E
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.