GlaucomaTIGTNCT07592988
Tear Interleukin Biomarkers After Glaucoma Treatment
A study testing MicroPulse Transscleral Cyclophotocoagulation, Conventional Transscleral Cyclophotocoagulation and Antiglaucoma Surgery in people with Glaucoma, run by Kazakh Eye Research Institute at 1 site in Kazakhstan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- MicroPulse Transscleral Cyclophotocoagulation, Conventional Transscleral Cyclophotocoagulation and Antiglaucoma Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteKazakhstan
- Study dates
- 18 May 2026to 19 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tear Fluid Interleukin Biomarkers and Intraocular Pressure Response After Micropulse Transscleral Cyclophotocoagulation, Conventional Cyclophotocoagulation, and Antiglaucoma Surgery in Patients With Glaucoma
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.
- Conditions
- Glaucoma
- Being tested
- MicroPulse Transscleral Cyclophotocoagulation, Conventional Transscleral Cyclophotocoagulation, Antiglaucoma Surgery
- Keywords
- Glaucoma, Micropulse Laser
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroPulse Transscleral CyclophotocoagulationProcedure or surgery
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.
Conventional Transscleral CyclophotocoagulationProcedure or surgery
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.
Antiglaucoma SurgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Antiglaucoma Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 5-7 days after treatment, and 1 month after treatment
Secondary outcomes (3)
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.
Measured: Baseline, 5-7 days after treatment, and 1 month after treatment
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.
Measured: Baseline, 5-7 days after treatment, and 1 month after treatment
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.
Measured: Up to 1 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start18 May 2026
- Primary completion18 Aug 2026
- Study completion19 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kazakh Eye Research Institute
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Assiya Shaikenova, MD, Principal investigator, Kazakh Eye Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592988
- Sponsor's protocol ID
- 193/2
- Acronym
- TIGT
- Status last verified
- Oct 2026
- First submitted
- 12 May 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tear Fluid Interleukin Biomarkers and Intraocular Pressure Response After Micropulse Transscleral Cyclophotocoagulation, Conventional Cyclophotocoagulation, and Antiglaucoma Surgery in Patients With Glaucoma
- ClinicalTrials.gov ID
- NCT07592988
- Acronym / sponsor ID
- TIGT / 193/2
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Micropulse Laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kazakh Eye Research InstituteResearch network
- Study start
- 18 May 2026 (actual)
- Primary completion
- 18 Aug 2026 (actual)
- Study completion
- 19 Aug 2026 (actual)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MicroPulse Transscleral Cyclophotocoagulation Group | Experimental | Procedure: MicroPulse Transscleral CyclophotocoagulationParticipants 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. |
| Conventional Transscleral Cyclophotocoagulation Group | Active comparator | Procedure: Conventional Transscleral CyclophotocoagulationParticipants 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. |
| Antiglaucoma Surgery Group | Active comparator | Procedure: Antiglaucoma SurgeryParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicroPulse Transscleral CyclophotocoagulationMicroPulse 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. | Procedure or surgery | MicroPulse Transscleral Cyclophotocoagulation Group |
| Conventional Transscleral CyclophotocoagulationConventional 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. | Procedure or surgery | Conventional Transscleral Cyclophotocoagulation Group |
| Antiglaucoma SurgeryIncisional 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. | Procedure or surgery | Antiglaucoma Surgery Group |
Primary outcome
Association Between Changes in Tear Fluid Interleukin Levels and Intraocular Pressure Reduction
Time frame: Baseline, 5-7 days after treatment, and 1 month after treatment
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.
3 secondary outcomes
Change in Tear Fluid Interleukin Concentrations After Glaucoma Treatment
Time frame: Baseline, 5-7 days after treatment, and 1 month after treatment
Comparison of Inflammatory Response Patterns Between Treatment Groups
Time frame: Baseline, 5-7 days after treatment, and 1 month after treatment
Rate of Postoperative Complications
Time frame: Up to 1 month after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Assiya Shaikenova, MD principal investigator
Kazakh Eye Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MicroPulse Transscleral Cyclophotocoagulation, Conventional Transscleral Cyclophotocoagulation and Antiglaucoma Surgery in people with Glaucoma, run by Kazakh Eye Research Institute at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association Between Changes in Tear Fluid Interleukin Levels and Intraocular Pressure Reduction (time frame: Baseline, 5-7 days after treatment, and 1 month after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.