Clinical trial NCT05437614: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Treatment of Refractory Glaucoma
Lead sponsor: University of Health Sciences Lahore
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: postoperative complications
timeFrame: 1 year
measure: Reduced IOP
timeFrame: 1 year
measure: Decrease in number of hypotensive drugs
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Holy Family Hospital
state: Punjab
Study officials:
References: