ClinicalTrials.gg
CompletedNCT07592988TIGTUpdated Oct 16, 2026

Tear Interleukin Biomarkers After Glaucoma Treatment

An interventional study of MicroPulse Transscleral Cyclophotocoagulation and Conventional Transscleral Cyclophotocoagulation in Glaucoma, sponsored by Kazakh Eye Research Institute. Completed at 1 site in Kazakhstan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by Kazakh Eye Research Institute · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed description

Glaucoma is a chronic progressive optic neuropathy characterized by irreversible visual field loss. Reduction of intraocular pressure (IOP) remains the only evidence-based strategy to slow disease progression. Various treatment modalities, including laser procedures such as micropulse transscleral cyclophotocoagulation (MP-CPC) and continuous-wave cyclophotocoagulation (CPC), as well as incisional antiglaucoma surgeries, are widely used to achieve IOP control.

Inflammation is believed to play a differential role in the biological response to various glaucoma interventions. In the context of CPC and MP-CPC a controlled ("subthreshold") inflammatory response may contribute to structural and functional remodeling of the ciliary body, potentially enhancing the hypotensive effect. Interleukins present in tear fluid represent accessible, non-invasive biomarkers of ocular surface and intraocular inflammatory activity. Changes in their concentrations may reflect procedure-induced tissue response and could potentially serve as predictors of treatment efficacy.

In contrast, following incisional antiglaucoma surgeries, inflammation is more often associated with fibrotic processes, wound healing, and scar formation, which may negatively affect surgical outcomes by limiting aqueous outflow.

However, the dynamics of inflammatory mediators in the tear film following different glaucoma treatments and their relationship with IOP reduction remain insufficiently studied.

This prospective study will include patients with various types of glaucoma scheduled to undergo MP-CPC, CPC, or incisional antiglaucoma surgery. Tear samples will be collected at three time points: preoperatively (baseline), 5-7 days after treatment, and 1 month postoperatively. The concentrations of selected pro-inflammatory (IL-4, IL-6) interleukins will be measured using standardized immunoassay techniques.

Intraocular pressure will be assessed at the same time points using Corvis ST tonometry.

The primary objective of the study is to evaluate the correlation between changes in tear interleukin levels and IOP reduction at early (5-7 days) and short-term (1 month) follow-up.

Secondary objectives include:

Assessment of temporal changes in interleukin profiles after different glaucoma treatments, Comparison of inflammatory responses between MP-CPC, CPC, and surgery groups, Evaluation of the relationship between baseline interleukin levels and the degree of IOP reduction, Identification of interleukin patterns associated with a clinically significant hypotensive response, Safety evaluation, including postoperative complications and ocular surface status.

Correlation and regression analyses will be performed to determine whether baseline interleukin levels and their early postoperative changes can predict the degree and stability of IOP reduction.

The identification of inflammatory biomarkers associated with treatment response may contribute to a better understanding of the role of inflammation in glaucoma management and support the development of personalized therapeutic strategies.

02

Conditions studied

  • Glaucoma

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Keywords

  • Glaucoma
  • Micropulse Laser
03

In context

Glaucoma

1,419 studies on the registry are indexed under Glaucoma; 223 are open to participants now.

This study's enrollment of 24 is below the median of 61 across 964 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Kazakh Eye Research Institute is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Patients age less than 18 years
  • Patients unable or unwilling to provide 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    MicroPulse Transscleral Cyclophotocoagulation Group

    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

  • Active comparator
    Conventional Transscleral Cyclophotocoagulation Group

    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

  • Active comparator
    Antiglaucoma Surgery Group

    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

  • ProcedureMicroPulse Transscleral Cyclophotocoagulation

    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.

  • ProcedureConventional Transscleral Cyclophotocoagulation

    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.

  • ProcedureAntiglaucoma Surgery

    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.

06

What researchers measure

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.

    Time frame: Baseline, 5-7 days after treatment, and 1 month after treatment

Secondary outcomes

  1. Change in Tear Fluid Interleukin Concentrations After Glaucoma Treatment

    This outcome will evaluate temporal changes in tear fluid interleukin concentrations after different glaucoma treatment modalities, including MicroPulse transscleral cyclophotocoagulation, conventional transscleral cyclophotocoagulation, and incisional antiglaucoma surgery. Tear fluid samples will be collected at baseline, 5-7 days after treatment, and 1 month postoperatively.

    Time frame: Baseline, 5-7 days after treatment, and 1 month after treatment

  2. Comparison of Inflammatory Response Patterns Between Treatment Groups

    This outcome will compare postoperative inflammatory biomarker patterns between the MicroPulse transscleral cyclophotocoagulation group, conventional transscleral cyclophotocoagulation group, and incisional antiglaucoma surgery group. Differences in tear fluid interleukin levels and their postoperative dynamics will be analyzed between the groups.

    Time frame: Baseline, 5-7 days after treatment, and 1 month after treatment

  3. Rate of Postoperative Complications

    This outcome will assess the rate of postoperative complications after glaucoma treatment, including hypotony, corneal edema, hyphema, iritis, vitreous hemorrhage, cystoid macular edema, ocular surface inflammation, and other procedure-related adverse events.

    Time frame: Up to 1 month after treatment

07

Study locations

1 site
  • Kazakh Eye Research Institute
    Almaty, 050012, Kazakhstan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2026 to primary completion in Aug 2026, 3 months.

Of 229 non-industry interventional studies with no phase under Glaucoma, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 55. This study's 3 months is below that.

Counting every sponsor, half of 287 studies reached it within 30 months; a quarter within 12 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
May 12, 2026
First posted
May 18, 2026
StartActual
May 18, 2026
Primary completionActual
Aug 18, 2026
CompletionActual
Aug 19, 2026
Last update
Oct 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 16, 2026
Show all 1 update
  1. Oct 16, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07592988
Lead sponsor
Kazakh Eye Research Institute
Responsible party
Sponsor
First posted
May 18, 2026
Start date
May 18, 2026
Primary completion
Aug 18, 2026
Completion
Aug 19, 2026
Last update
Oct 16, 2026

Study contacts

Assiya Shaikenova, MD
principal investigator · Kazakh Eye Research Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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