Comparison of Outcome and Effectiveness Between Micropulse Diode Laser Cyclophotocoagulation and Cyclocryoablation in Treatment of Refractory Glaucoma

Sponsor
University of Health Sciences Lahore (Other)
Overall Status
Recruiting
CT.gov ID
NCT05437614
Collaborator
(none)
47
1
2
12
3.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Micropulse diode laser cyclophotocoagulation in treatment of refractory Glaucoma
  • Procedure: Cyclocryoablation in treatment of refractory Glaucoma
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
47 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of Outcome and Effectiveness Between Micropulse Diode Laser Cyclophotocoagulation and Cyclocryoablation in Treatment of Refractory Glaucoma
Actual Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Treatment of refractory glaucoma using Micropulse diode laser cyclophotocoagulation

Procedure: Micropulse diode laser cyclophotocoagulation in treatment of refractory Glaucoma
Treatment of refractory Glaucoma by Micropulse diode laser cyclophotocoagulation

Active Comparator: Treatment of refractory glaucoma using cyclocryoablation

Procedure: Cyclocryoablation in treatment of refractory Glaucoma
Treatment of refractory Glaucoma by cyclocryoablation

Outcome Measures

Primary Outcome Measures

  1. postoperative complications [1 year]

    Hypotony, Fibrinous uveitis, Cystoid macular edema

  2. Reduced IOP [1 year]

    Reduction in IOP to less than 21 mmHg medications required to control IOP

  3. Decrease in number of hypotensive drugs [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Holy Family Hospital Rawalpindi Punjab Pakistan 46000

Sponsors and Collaborators

  • University of Health Sciences Lahore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mariam Noor, Post Graduate Trainee, University of Health Sciences Lahore
ClinicalTrials.gov Identifier:
NCT05437614
Other Study ID Numbers:
  • UniversityHSL786
First Posted:
Jun 29, 2022
Last Update Posted:
Jun 29, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 29, 2022