Back to resultsThe Effect of Direct Cyclophotocoagulation Using Endolaser in Silicon Induced Glaucoma: a Pilot Study.
Primary Purpose
Glaucoma
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Cyclophotocoagulation
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:
1- Patients above 18 years of age. 2- silicon filled for more than 2 months. 3- IOP more than 21 mmHg on triple topical antiglaucoma eye drops.
Exclusion Criteria: 1- history of glaucoma prior to the initial retinal surgery. 2- Immediate rise of IOP after SOI. 3- History of previous laser application to the ciliary body. 4- Any contraindications for silicone oil removal.
Sites / Locations
- Ain Shams University
Outcomes
Primary Outcome Measures
IOP lowering in patients with silicon induced glaucoma
Secondary Outcome Measures
Full Information
NCT ID
NCT05231252
First Posted
January 28, 2022
Last Updated
November 18, 2022
Sponsor
Kafrelsheikh University
1. Study Identification
Unique Protocol Identification Number
NCT05231252
Brief Title
The Effect of Direct Cyclophotocoagulation Using Endolaser in Silicon Induced Glaucoma: a Pilot Study.
Official Title
The Effect of Direct Cyclophotocoagulation Using Endolaser in Silicon Induced Glaucoma: a Pilot Study.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
January 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kafrelsheikh 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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Transcleral cyclophotocoagulation has been used to treat glaucoma secondary to silicone oil
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
pilot
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Cyclophotocoagulation
Intervention Description
Transcleral cyclophotocoagulation is used to treat glaucoma secondary to silicone oil.
Primary Outcome Measure Information:
Title
IOP lowering in patients with silicon induced glaucoma
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
. Patients above 18 years of age. .Silicon filled for more than 2 months. .IOP more than 21 mmHg on triple topical antiglaucoma eye drops.
Exclusion Criteria: . History of glaucoma prior to the initial retinal surgery. . Immediate rise of IOP after SOI. . History of previous laser application to the ciliary body. . Any contraindications for silicone oil removal.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed A.Mohamed, PhD
Organizational Affiliation
Ain Shams University,Faculty of medicine
Official's Role
Study Director
Facility Information:
Facility Name
Ain Shams University
City
Cairo
ZIP/Postal Code
11771
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
will not be shared til manuscript publishment
Learn more about this trial
The Effect of Direct Cyclophotocoagulation Using Endolaser in Silicon Induced Glaucoma: a Pilot Study.
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