NCT07592988

Brief Summary

This prospective study aims to evaluate inflammatory biomarkers in tear fluid in patients with glaucoma undergoing micropulse transscleral cyclophotocoagulation (MP-CPC), continuous-wave cyclophotocoagulation (CPC), and antiglaucoma surgeries. The study will assess the concentrations of pro- and anti-inflammatory interleukins in tear samples collected before treatment, 5-7 days after the procedure, and 1 month postoperatively. Intraocular pressure (IOP) will be measured at the same time points. The correlation between changes in interleukin levels and IOP reduction will be analyzed. Additionally, the study aims to compare inflammatory response patterns among the MP-CPC, CPC, and surgical treatment groups and to identify interleukin profiles associated with a clinically significant hypotensive effect.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
May 2026Aug 2026

First Submitted

Initial submission to the registry

May 12, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

May 18, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2026

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

May 12, 2026

Last Update Submit

May 12, 2026

Conditions

Glaucoma

Keywords

GlaucomaMicropulse Laser

Outcome Measures

Primary Outcomes (1)

  • Association Between Changes in Tear Fluid Interleukin Levels and Intraocular Pressure Reduction

    This outcome will assess the association between changes in tear fluid interleukin concentrations and the reduction in intraocular pressure after glaucoma treatment. Tear fluid levels of selected interleukins, including IL-4 and IL-6, will be measured before treatment, 5-7 days after treatment, and 1 month postoperatively. Intraocular pressure will be measured at the same time points. Correlation and regression analyses will be performed to evaluate whether changes in interleukin levels are associated with the magnitude of intraocular pressure reduction.

    Baseline, 5-7 days after treatment, and 1 month after treatment

Secondary Outcomes (3)

  • Change in Tear Fluid Interleukin Concentrations After Glaucoma Treatment

    Baseline, 5-7 days after treatment, and 1 month after treatment

  • Comparison of Inflammatory Response Patterns Between Treatment Groups

    Baseline, 5-7 days after treatment, and 1 month after treatment

  • Rate of Postoperative Complications

    Up to 1 month after treatment

Study Arms (3)

MicroPulse Transscleral Cyclophotocoagulation Group

EXPERIMENTAL

Participants in this group will undergo MicroPulse transscleral cyclophotocoagulation for the treatment of glaucoma. Tear samples and intraocular pressure measurements will be collected before treatment, 5-7 days after the procedure, and 1 month postoperatively to evaluate inflammatory biomarker changes and treatment response.

Procedure: MicroPulse Transscleral Cyclophotocoagulation

Conventional Transscleral Cyclophotocoagulation Group

ACTIVE COMPARATOR

Participants in this group will undergo conventional continuous-wave transscleral cyclophotocoagulation for the treatment of glaucoma. Tear samples and intraocular pressure measurements will be collected before treatment, 5-7 days after the procedure, and 1 month postoperatively to evaluate inflammatory biomarker changes and treatment response.

Procedure: Conventional Transscleral Cyclophotocoagulation

Antiglaucoma Surgery Group

ACTIVE COMPARATOR

Participants in this group will undergo incisional antiglaucoma surgery for the treatment of glaucoma. Tear samples and intraocular pressure measurements will be collected before surgery, 5-7 days after surgery, and 1 month postoperatively to evaluate inflammatory biomarker changes and treatment response.

Procedure: Antiglaucoma Surgery

Interventions

MicroPulse Transscleral CyclophotocoagulationPROCEDURE

MicroPulse transscleral cyclophotocoagulation will be performed as a laser procedure for the treatment of glaucoma. The procedure will be applied transsclerally over the ciliary body using micropulse laser energy. Tear fluid samples will be collected before treatment, 5-7 days after the procedure, and 1 month postoperatively for assessment of interleukin levels. Intraocular pressure will be measured at the same time points.

MicroPulse Transscleral Cyclophotocoagulation Group
Conventional Transscleral CyclophotocoagulationPROCEDURE

Conventional continuous-wave transscleral cyclophotocoagulation will be performed as a laser procedure for the treatment of glaucoma. The procedure will be applied transsclerally over the ciliary body using continuous-wave laser energy. Tear fluid samples will be collected before treatment, 5-7 days after the procedure, and 1 month postoperatively for assessment of interleukin levels. Intraocular pressure will be measured at the same time points.

Conventional Transscleral Cyclophotocoagulation Group
Antiglaucoma SurgeryPROCEDURE

Incisional antiglaucoma surgery will be performed for the treatment of glaucoma according to the clinical indication and standard surgical protocol. Tear fluid samples will be collected before surgery, 5-7 days after surgery, and 1 month postoperatively for assessment of interleukin levels. Intraocular pressure will be measured at the same time points.

Antiglaucoma Surgery Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Decision to treat by MP-CPC Laser
  • Patients diagnosed with Glaucoma
  • Patients aged 18 years old and above
  • Glaucoma that is inadequately controlled on medical therapy

You may not qualify if:

  • Patients age less than 18 years
  • Patients unable or unwilling to provide informed consent to participate in the study
  • Patients potentially unavailable for follow up visits
  • Patients with significant scleral thinning
  • Patients with ocular infection, inflammation or intraocular surgery in the study eye 2 months prior to enrollment in the study
  • Albino patients that have no iris pigmentation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kazakh Eye Research Institute

Almaty, 050012, Kazakhstan

RECRUITING

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Assiya Shaikenova, MD

    Kazakh Eye Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Assiya Shaikenova, MD

CONTACT

+77055689966shaikenova93@mail.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2026

First Posted

May 18, 2026

Study Start

May 18, 2026

Primary Completion (Estimated)

August 18, 2026

Study Completion (Estimated)

August 18, 2026

Last Updated

May 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

KA(1)