Comparison of Outcome and Effectiveness Between Micropulse Diode Laser Cyclophotocoagulation and Cyclocryoablation in Treatment of Refractory Glaucoma
Primary Purpose
Treatment of Refractory Glaucoma
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Micropulse diode laser cyclophotocoagulation in treatment of refractory Glaucoma
Cyclocryoablation in treatment of refractory Glaucoma
Sponsored by
About this trial
This is an interventional treatment trial for Treatment of Refractory Glaucoma
Eligibility Criteria
Inclusion Criteria:
Positive diagnosis of refractory glaucoma
- Poor visual acuity: Hand movements or less
- Age ≥ 18 years
- Intraocular pressure ≥ 21 mmHg
- Signed informed consent
Exclusion Criteria:
- Eye surgery performed over the last 3 months
- Eye inflammation
Sites / Locations
- Holy Family HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Treatment of refractory glaucoma using Micropulse diode laser cyclophotocoagulation
Treatment of refractory glaucoma using cyclocryoablation
Arm Description
Outcomes
Primary Outcome Measures
postoperative complications
Hypotony, Fibrinous uveitis, Cystoid macular edema
Reduced IOP
Reduction in IOP to less than 21 mmHg medications required to control IOP
Decrease in number of hypotensive drugs
Secondary Outcome Measures
Full Information
NCT ID
NCT05437614
First Posted
June 5, 2022
Last Updated
June 23, 2022
Sponsor
University of Health Sciences Lahore
1. Study Identification
Unique Protocol Identification Number
NCT05437614
Brief Title
Comparison of Outcome and Effectiveness Between Micropulse Diode Laser Cyclophotocoagulation and Cyclocryoablation in Treatment of Refractory Glaucoma
Official Title
Comparison of Outcome and Effectiveness Between Micropulse Diode Laser Cyclophotocoagulation and Cyclocryoablation in Treatment of Refractory Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Health Sciences Lahore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
laucoma having bad prognosis after maximally tolerated medication,glaucoma that fails after filtering operations, neovascular glaucoma, glaucoma following vitrectomy and glaucoma secondary to uveitis etc. is collectively termed as refractory glaucoma. For such glaucoma patients, cyclodestructive procedures are often used to reduce IOP, as well as to relieve ocular and periocular pain. Recently,diode laser transscleral cyclophotocoagulation has proved to be an effective method for the treatment of refractory glaucoma and it has become a standard treatment for refractory glaucoma.(Yu, Q., Liang, Y., Ji, F. and Yuan, Z.,et al 2020. ) In previous articles, little is known about the long-term outcomes of micropulse diode laser cyclophotocoagulation and cyclocryotherapy. Discrepancies in the results of several large observational analyses have introduced further ambiguity on the role of micropulse diode laser cyclophotocoagulation and cyclocryotherapy.The mechanism of transcleral cyclophotocoagulation IOP lowering in refractory glaucoma is not well understood. In this study, we perform cyclocryoablation and micropulse diode laser cyclophotocoagulation in patients with refractory glaucoma and report the outcomes / mechanism of IOP control using this new surgical paradigm. The objective of our project is to assess the end result and outcome of the role of micropulse diode laser cyclophotocoagulation and cyclocryotherapy.We aim to evaluate the comparison between micropulse diode laser cyclophotocoagulation and cyclocryotherapy.
Only those subjects will be recruited who provide written informed consent. Patients are diagnosed on bases of tonometry, gonioscopy, ophthalmoscopy, perimetry. Patients' age, gender, type of glaucoma, number of diode laser treatment sessions, postoperative complications, number of hypotensive medications required to control IOP, and best corrected visual acuity (BCVA) will be evaluated. The criteria for success will be defined as postoperative IOP <21 mmHg or >20% decrease in IOP with or without additional medical treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment of Refractory Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment of refractory glaucoma using Micropulse diode laser cyclophotocoagulation
Arm Type
Active Comparator
Arm Title
Treatment of refractory glaucoma using cyclocryoablation
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Micropulse diode laser cyclophotocoagulation in treatment of refractory Glaucoma
Intervention Description
Treatment of refractory Glaucoma by Micropulse diode laser cyclophotocoagulation
Intervention Type
Procedure
Intervention Name(s)
Cyclocryoablation in treatment of refractory Glaucoma
Intervention Description
Treatment of refractory Glaucoma by cyclocryoablation
Primary Outcome Measure Information:
Title
postoperative complications
Description
Hypotony, Fibrinous uveitis, Cystoid macular edema
Time Frame
1 year
Title
Reduced IOP
Description
Reduction in IOP to less than 21 mmHg medications required to control IOP
Time Frame
1 year
Title
Decrease in number of hypotensive drugs
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Positive diagnosis of refractory glaucoma
Poor visual acuity: Hand movements or less
Age ≥ 18 years
Intraocular pressure ≥ 21 mmHg
Signed informed consent
Exclusion Criteria:
Eye surgery performed over the last 3 months
Eye inflammation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mariam Noor, MBBS
Phone
923314512003
Email
drmariam133@gmail.com
Facility Information:
Facility Name
Holy Family Hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariam Noor, MBBS
Phone
923314512003
Email
drmariam133@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Comparison of Outcome and Effectiveness Between Micropulse Diode Laser Cyclophotocoagulation and Cyclocryoablation in Treatment of Refractory Glaucoma
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