NCT04151550

Safety & Efficacy of the Laser Scleral Microporation Procedure (Philippines)

Evaluation of the Safety and Efficacy of the Laser Scleral Microporation Procedure to Restore Visual Function and Range of Accommodation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: ACE Vision Group, Inc. · Industry
• Sex: All
• Age: 48 Years
• Healthy volunteers: Accepted

Summary

A minimally invasive procedure for treating presbyopia is being evaluated to determine if there is improvement in near and intermediate vision after treatment.

Detailed description

This is a prospective, controlled, single-center clinical study to evaluate the safety and efficacy of the Laser Scleral Microporation Procedure. Laser Scleral Microporation Procedure is a treatment to restore visual and accommodative function in presbyopic patients. The subjects are bilaterally treated with the Laser Scleral Microporation procedure.

Conditions

• Presbyopia

Interventions

Type	Name	Description
DEVICE	Bilateral Laser Scleral Microporation procedure	Device: Laser Scleral Microporation Partial depth scleral microporations with an Er:YAG laser in a predetermined pattern.

Timeline

• Start date: 2019-09-25
• Primary completion: 2024-12-18
• Completion: 2025-02-28
• First posted: 2019-11-05
• Last updated: 2025-03-10

Locations

1 site across 1 country: Philippines