CPC in Adult Refractory Glaucoma

• Sponsor: Sohag University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04921098
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 9
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the relative effectiveness and safety of diode laser cyclophotocoagulation procedure to reduce IOP and relieve pain in adult patients with refractory glaucoma.

Condition or Disease	Intervention/Treatment	Phase
Refractory Glaucoma	Procedure: Diode Laser Cyclophotocoagulation	N/A

Detailed Description

A hospital -based, prospective interventional non comparative case series study.This study will be conducted on patients with refractory glaucoma whose ages are 18 years and older.They will be subjected to Transscleral Diode Laser Cyclophotocoagulation.

Postoperative evaluation will be scheduled for the first day postoperative, then 1 week later and then at 1st, 3rd, month postoperative.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Diode Laser Cyclophotocoagulation in Adult Refractory Glaucoma
• Actual Study Start Date: Jul 1, 2021
• Anticipated Primary Completion Date: Apr 1, 2022
• Anticipated Study Completion Date: Apr 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Refractory glaucoma	Procedure: Diode Laser Cyclophotocoagulation; A handpiece (G probe) is used to deliver the diode laser energy with a wavelength of 810 nm.

Outcome Measures

Primary Outcome Measures

1. change in intraocular pressure [First day postoperative and 1 week]

   IOP measuring using Goldmann applanation tonometer.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Inclusion Criteria:

1. Patients with refractory glaucoma aging 18 years and older.

2. Both sexes are included.

3. Patients Capable of giving informed consent.

4. Pseudophkic glaucoma.

5. Aphakic glaucoma.

6. Silicon oil induced glaucoma.

7. Neovascular glaucoma.

8. Inflammatory glaucoma.

Exclusion Criteria:

1. Patients <18 years of age.

2. Patients controlled on regular antiglaucomatous therapy.

3. Patients who cannot do regular follow up visits.

4. Diffuse scleral staphyloma at the site of CPC.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sohag University	Sohag		Egypt

Sponsors and Collaborators

• Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Ansari E, Gandhewar J. Long-term efficacy and visual acuity following transscleral diode laser photocoagulation in cases of refractory and non-refractory glaucoma. Eye (Lond). 2007 Jul;21(7):936-40. Epub 2006 Apr 21.
• Lai JS, Tham CC, Chan JC, Lam DS. Diode laser transscleral cyclophotocoagulation in the treatment of chronic angle-closure glaucoma: a preliminary study. J Glaucoma. 2003 Aug;12(4):360-4.
• Nassiri N, Kamali G, Rahnavardi M, Mohammadi B, Nassiri S, Rahmani L, Nassiri N. Ahmed glaucoma valve and single-plate Molteno implants in treatment of refractory glaucoma: a comparative study. Am J Ophthalmol. 2010 Jun;149(6):893-902. doi: 10.1016/j.ajo.2010.01.025. Epub 2010 May 8.

• Responsible Party: Mina Abdelmalek Besada, Principal Investigator, Sohag University
• ClinicalTrials.gov Identifier: NCT04921098
• Other Study ID Numbers: Soh-Med-21-05-01
• First Posted: Jun 10, 2021
• Last Update Posted: Jan 11, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Glaucoma

Study Results

No Results Posted as of Jan 11, 2022