ConjunctivaNCT06353776
MicroPulse Transscleral Laser Therapy and Its Short-term Impact on Ocular Surface
A study testing conjunctival biopsy after micropulse transscleral laser therapy in people with Conjunctiva and Cornea, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
MicroPulse transscleral laser therapy (TLT) is proven to be effective in reducing intraocular pressure with minimal complications in either primary or secondary glaucoma. However, its impact on the human ocular surface remains unexplored. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conjunctiva, Cornea
- What is being tested?
- conjunctival biopsy after micropulse transscleral laser therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTunisia
- Study dates
- 3 May 2023to 31 Oct 2023
- 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
- Age > 18 years old
- Non-controlled open-angle glaucoma despite undergoing maximal medical therapy
- Poor therapeutic adherence
- Local or general intolerance to topical treatments.
Who cannot join
- Ophthalmic or general diseases that could potentially impact the conjunctiva such as symblepharon, ocular injury, or prior eye surgery
- Pevious transscleral laser therapy applied to the same eye
- angle-closure glaucoma
- active ocular inflammation
- a non-functional eye (absence of light perception)
- scleral thinning
Trial locations and contacts
1 site in 1 country.
About this study
MicroPulse transscleral laser therapy (TLT) is proven to be effective in reducing intraocular pressure with minimal complications in either primary or secondary glaucoma. However, its impact on the human ocular surface remains unexplored. This study aims to bridge this gap by examining the clinical and histopathological effects of MicroPulse TLT on the ocular surface.
Read the detailed description
This prospective study, conducted at Mohamed Taher Maamouri University Hospital in Nabeul, Tunisia, investigates the clinical and histopathological short-term effects of MicroPulse transscleral laser therapy (TLT) on the ocular surface. The study involves 16 eyes from 15 adult patients. Participants underwent MicroPulse TLT, followed by conjunctival biopsies for the analysis of inflammation and fibrosis. Participants also benefited from ophthalmological examination and responded to the Ocular Surface Disease Index (OSDI) questionnaire before and after MicroPulse TLT.
- Conditions
- Conjunctiva, Cornea
- Being tested
- conjunctival biopsy after micropulse transscleral laser therapy
- Keywords
- MicroPulse, transscleral laser therapy, ocular surface, inflammation, fibrosis, glaucoma
- Medical subject headings
- Corneal Diseases, Inflammation, Fibrosis, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conjunctival biopsy after micropulse transscleral laser therapyProcedure or surgery
During MicroPulse TLT, all patients received periocular anesthesia, with an injection of 5 to 10 ml of Lidocaine (Xylocaine 5mg/ml ®) to achieve complete anesthesia.
The investigators employed the 810 nm Cyclo G6® Laser in its MicroPulse® mode (Iridex Corporation, Mountain View, CA, USA) and delivered laser energy to the eye using the second-generation MicroPulse P3® probe (Iridex Corporation, Mountain View, CA, USA). The laser was calibrated to generate a power output of 2500 mW, and a MicroPulse duty cycle of 31.3%. The curved end of the probe's footplate (bunny ears) was positioned 0.5 to 1 mm away from the corneoscleral limbus, maintaining a perpendicular orientation to the eyeball.
Following the laser therapy, an immediate conjunctival biopsy measuring 2 * 2 mm and avoiding the laser-treated region was performed.
| Study group | Role | What they receive |
|---|---|---|
| MP-TLT + conjunctival biopsy | Experimental | Participants underwent MicroPulse transscleral laser therapy, followed by conjunctival biopsies for the analysis of inflammation and fibrosis. Receives: Procedure: conjunctival biopsy after micropulse transscleral laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
conjunctival inflammation or fibrosis
histological changes of the conjunctiva according to a scale ranging from 0 to 3, with the following interpretation:
- Grade 0: no difference between the two samples
- Grade 1: increase in inflammation / fibrosis < 33%
- Grade 2: increase in inflammation / fibrosis from 33% to 66%
- Grade 3: increase in inflammation / fibrosis > 66%
Measured: 1 month
intraocular pression
change in intraocular pression
Measured: 6 months
ocular surface disease index score
This score is calculated and ranges from 0 to 100 with the following interpretation:
- 0 to 12 = Normal
- 13 to 22 = Mild ocular surface disease
- 23 to 32 = Moderate ocular surface disease
- 33 to 100 = Severe ocular surface disease
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start3 May 2023
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConjunctivaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walid Zbiba, University Tunis El Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353776
- Sponsor's protocol ID
- 02052023
- Status last verified
- Apr 2024
- First submitted
- 25 Mar 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MicroPulse Transscleral Laser Therapy and Its Short-term Impact on Ocular Surface
- ClinicalTrials.gov ID
- NCT06353776
- Acronym / sponsor ID
- 02052023
- Conditions
- Conjunctiva, Cornea
- Keywords
- MicroPulse, transscleral laser therapy, ocular surface, inflammation, fibrosis, glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 3 May 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 9 Apr 2024 (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.
MicroPulse transscleral laser therapy (TLT) is proven to be effective in reducing intraocular pressure with minimal complications in either primary or secondary glaucoma. However, its impact on the human ocular surface remains unexplored. This study aims to bridge this gap by examining the clinical and histopathological effects of MicroPulse TLT on the ocular surface.
Detailed description
This prospective study, conducted at Mohamed Taher Maamouri University Hospital in Nabeul, Tunisia, investigates the clinical and histopathological short-term effects of MicroPulse transscleral laser therapy (TLT) on the ocular surface. The study involves 16 eyes from 15 adult patients. Participants underwent MicroPulse TLT, followed by conjunctival biopsies for the analysis of inflammation and fibrosis. Participants also benefited from ophthalmological examination and responded to the Ocular Surface Disease Index (OSDI) questionnaire before and after MicroPulse TLT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MP-TLT + conjunctival biopsy | Experimental | Procedure: conjunctival biopsy after micropulse transscleral laser therapyParticipants underwent MicroPulse transscleral laser therapy, followed by conjunctival biopsies for the analysis of inflammation and fibrosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years old
- Non-controlled open-angle glaucoma despite undergoing maximal medical therapy
- Poor therapeutic adherence
- Local or general intolerance to topical treatments.
Key exclusion criteria (6 listed)
- Ophthalmic or general diseases that could potentially impact the conjunctiva such as symblepharon, ocular injury, or prior eye surgery
- Pevious transscleral laser therapy applied to the same eye
- angle-closure glaucoma
- active ocular inflammation
- a non-functional eye (absence of light perception)
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 |
|---|---|---|
| conjunctival biopsy after micropulse transscleral laser therapyDuring MicroPulse TLT, all patients received periocular anesthesia, with an injection of 5 to 10 ml of Lidocaine (Xylocaine 5mg/ml ®) to achieve complete anesthesia. The investigators employed the 810 nm Cyclo G6® Laser in its MicroPulse® mode (Iridex Corporation, Mountain View, CA, USA) and delivered laser energy to the eye using the second-generation MicroPulse P3® probe (Iridex Corporation, Mountain View, CA, USA). The laser was calibrated to generate a power output of 2500 mW, and a MicroPulse duty cycle of 31.3%. The curved end of the probe's footplate (bunny ears) was positioned 0.5 to 1 mm away from the corneoscleral limbus, maintaining a perpendicular orientation to the eyeball. Following the laser therapy, an immediate conjunctival biopsy measuring 2 * 2 mm and avoiding the laser-treated region was performed. | Procedure or surgery | MP-TLT + conjunctival biopsy |
Primary outcome
conjunctival inflammation or fibrosis
Time frame: 1 month
histological changes of the conjunctiva according to a scale ranging from 0 to 3, with the following interpretation: * Grade 0: no difference between the two samples * Grade 1: increase in inflammation / fibrosis < 33% * Grade 2: increase in inflammation / fibrosis from 33% to 66% * Grade 3: increase in inflammation / fibrosis > 66%
intraocular pression
Time frame: 6 months
change in intraocular pression
ocular surface disease index score
Time frame: 6 months
This score is calculated and ranges from 0 to 100 with the following interpretation: * 0 to 12 = Normal * 13 to 22 = Mild ocular surface disease * 23 to 32 = Moderate ocular surface disease * 33 to 100 = Severe ocular surface disease
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 9 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conjunctival biopsy after micropulse transscleral laser therapy in people with Conjunctiva and Cornea, run by University Tunis El Manar at 1 site in Tunisia.
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 9 Apr 2024. 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 Tunisia. 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?
conjunctival inflammation or fibrosis (time frame: 1 month). The study lists 3 primary outcomes in all. 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 9 Apr 2024.