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

NCT ID: NCT05437614

Last Updated: 2022-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Treatment of Refractory Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment of refractory glaucoma using Micropulse diode laser cyclophotocoagulation

Group Type ACTIVE_COMPARATOR

Micropulse diode laser cyclophotocoagulation in treatment of refractory Glaucoma

Intervention Type PROCEDURE

Treatment of refractory Glaucoma by Micropulse diode laser cyclophotocoagulation

Treatment of refractory glaucoma using cyclocryoablation

Group Type ACTIVE_COMPARATOR

Cyclocryoablation in treatment of refractory Glaucoma

Intervention Type PROCEDURE

Treatment of refractory Glaucoma by cyclocryoablation

Interventions

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Micropulse diode laser cyclophotocoagulation in treatment of refractory Glaucoma

Treatment of refractory Glaucoma by Micropulse diode laser cyclophotocoagulation

Intervention Type PROCEDURE

Cyclocryoablation in treatment of refractory Glaucoma

Treatment of refractory Glaucoma by cyclocryoablation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Health Sciences Lahore

OTHER

Sponsor Role lead

Responsible Party

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Mariam Noor

Post Graduate Trainee

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Holy Family Hospital

Rawalpindi, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Mariam Noor, MBBS

Role: CONTACT

923314512003

Facility Contacts

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Mariam Noor, MBBS

Role: primary

923314512003

Other Identifiers

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UniversityHSL786

Identifier Type: -

Identifier Source: org_study_id

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