search
Back to results

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
University of Health Sciences Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment of Refractory Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 5, 2022
Last Updated
June 23, 2022
Sponsor
University of Health Sciences Lahore
search

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

We'll reach out to this number within 24 hrs