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CPC in Adult Refractory Glaucoma

Primary Purpose

Refractory Glaucoma

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Diode Laser Cyclophotocoagulation
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Sohag UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Refractory glaucoma

Arm Description

Outcomes

Primary Outcome Measures

change in intraocular pressure
IOP measuring using Goldmann applanation tonometer.

Secondary Outcome Measures

Full Information

First Posted
May 30, 2021
Last Updated
January 9, 2022
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT04921098
Brief Title
CPC in Adult Refractory Glaucoma
Official Title
Evaluation of Diode Laser Cyclophotocoagulation in Adult Refractory Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

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

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Refractory glaucoma
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Diode Laser Cyclophotocoagulation
Intervention Description
A handpiece (G probe) is used to deliver the diode laser energy with a wavelength of 810 nm.
Primary Outcome Measure Information:
Title
change in intraocular pressure
Description
IOP measuring using Goldmann applanation tonometer.
Time Frame
First day postoperative and 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Inclusion Criteria: Patients with refractory glaucoma aging 18 years and older. Both sexes are included. Patients Capable of giving informed consent. Pseudophkic glaucoma. Aphakic glaucoma. Silicon oil induced glaucoma. Neovascular glaucoma. Inflammatory glaucoma. Exclusion Criteria: Patients <18 years of age. Patients controlled on regular antiglaucomatous therapy. Patients who cannot do regular follow up visits. Diffuse scleral staphyloma at the site of CPC.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mina A Besada, Resident
Phone
01280899267
Email
mena011205@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Ismail M Abdellatif, Professor
Phone
01223629352
Facility Information:
Facility Name
Sohag University
City
Sohag
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osama R Elsherif, Professor

12. IPD Sharing Statement

Citations:
PubMed Identifier
16628239
Citation
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. doi: 10.1038/sj.eye.6702345. Epub 2006 Apr 21.
Results Reference
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PubMed Identifier
12897582
Citation
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. doi: 10.1097/00061198-200308000-00011.
Results Reference
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PubMed Identifier
20451896
Citation
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.
Results Reference
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Learn more about this trial

CPC in Adult Refractory Glaucoma

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