MicroPulse Transscleral Laser Cyclophotocoagulation With the Zig Zag Mode in Glaucoma.

NCT05521334 | Completed FDA Device

• 1 other identifier: Ahmed Sami Ahmed
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective single-arm clinical trial in which patients with neovascular or primary open angle glaucoma with uncontrolled intraocular pressure (despite maximal tolerated anti-glaucoma medical treatment) were selected for micro-pulse trans-scleral cyclophotocoagulation using an MP3 handpiece with Iridex Cyclo G6 Laser settings (2000mW of 810 nm infrared diode laser set on micro-pulse delivery mode with 31.3 % duty cycle). The laser will be delivered over three quadrants for 90 seconds for each quadrant (total 270 sec) in Zigzag mode sparing the fourth quadrant for either further intervention or a previous surgery performed. Follow up examination (for at least 6 months) will include assessment of IOP in terms of percentage of IOP reduction and sustainability of results, BCVA, and the number of medications post-operatively.

Conditions

Refractory Glaucoma

Outcome Measures

Primary Outcomes (1)

• Measuring the of intraocular pressure (in mmHg) using Goldman applanation tonometer to calculate the percentage of reduction.

  Intraocular pressure will be measured in (mmHg) using Goldman applanation tonometer (an instrument that is based on Imbert-Fick law. It is considered to be the gold standard instrument for measurement of Intraocular pressure (IOP).It was named after Austrian-Swiss ophthalmologist Hans Goldmann ) before the procedure then measured in the 1 week follow up , 1 month , 3 months and 6 months follow up where each measure will be divided by the preoperative IOP to calculate the percentage of intra ocular pressure reduction and monitor the stability of IOP. the success rate will be calculated depending on the rate of IOP reduction in the last follow up.

  6 months

Study Arms (1)

Adult Glaucomatous patients with refractory glaucoma

EXPERIMENTAL

Adult glaucomatous patients with uncontrolled intraocular pressure despite maximal tolerated medical treatment

Device: micropulse transscleral cyclophotocoagulation

Interventions

micropulse transscleral cyclophotocoagulation DEVICE

glaucomatous patients with uncontrolled intraocular pressure (despite maximal tolerated anti-glaucoma medical treatment) were selected for micro-pulse trans-scleral cyclophotocoagulation using an MP3 handpiece with Iridex Cyclo G6 Laser settings (2000mW of 810 nm infrared diode laser set on micro-pulse delivery mode with 31.3 % duty cycle). The laser will be delivered over three quadrants for 90 seconds for each quadrant (total 270 sec) in Zigzag mode sparing the fourth quadrant for either further intervention or a previous surgery performed. Follow up examination (for at least 6 months) will include assessment of IOP in terms of percentage of IOP reduction and sustainability of results, BCVA, and the number of medications post-operatively.

Adult Glaucomatous patients with refractory glaucoma

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with uncontrolled intraocular pressure
• on maximally tolerated medical treatment.
• Primary open angle glaucoma or neovascular glaucoma

You may not qualify if:

• patients with other types of glaucoma.

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

Helwan University

Helwan, Egypt

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• TareK Aboulnasr, MD

  Benha University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 30, 2022
• Study Start: March 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: April 1, 2022
• Last Updated: August 30, 2022

Record last verified: 2022-08

Locations

EG (1)