Comparing Refractive and Visual Outcomes of MIGS and Traditional Surgeries
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|ClinicalTrials.gov Identifier: NCT03584958|
Recruitment Status : Enrolling by invitation
First Posted : July 12, 2018
Last Update Posted : June 10, 2019
|Condition or disease|
|Glaucoma Ocular Hypertension|
There is an increasing number of surgical options to lower intraocular pressure (IOP) in patients with glaucoma and ocular hypertension performed with or without concurrent cataract surgery. Today, patients undergoing glaucoma surgery have increasingly higher expectations for their postoperative visual outcomes. Therefore, it is important to understand the influence of various glaucoma surgical procedures on refractive outcomes. This information would aid in patient and surgical procedure selection, pre-operative counseling to set appropriate expectations and may help surgeons adjust their plans and techniques to improve visual outcomes.
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.
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Comparing Refractive and Visual Outcomes of Minimally Invasive and Traditional Glaucoma Surgeries|
|Actual Study Start Date :||August 1, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||June 15, 2020|
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.
Suprachoroid stent and cataract surgery
Suprachoroidal stent (Cypass) to decrease intraocular pressure in combination with cataract surgery.
Glaucoma filtering surgery to decrease intraocular pressure.
Cataract surgery with no glaucoma procedure.
- Biometry prediction accuracy [ Time Frame: Baseline, Post-op Month 1, Post-op Month 3 ]Difference between the target refraction and the spherical equivalent of the final refraction following surgery.
- Post-operative corneal curvature [ Time Frame: Baseline, Post-op Month 1, Post-op Month 3 ]Variation in corneal curvature (astigmatism) following surgery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584958
|United States, Pennsylvania|
|Wills Eye Hospital|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Daniel Lee, MD||Wills Eye Hospital|