Refractory GlaucomaNCT05521334
MicroPulse Transscleral Laser Cyclophotocoagulation With the Zig Zag Mode in Glaucoma.
A study testing micropulse transscleral cyclophotocoagulation in people with Refractory Glaucoma, run by Helwan University at 1 site in Egypt.
Trial summary
This is a prospective single-arm clinical trial in which patients with neovascular or primary open angle glaucoma with uncontrolled intraocular pressure (despite maximal tolerated anti-glaucoma medical treatment) were selected for micro-pulse trans-scleral cyclophotocoagulation using an MP3 handpiece with Iridex Cyclo… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Refractory Glaucoma
- What is being tested?
- micropulse transscleral cyclophotocoagulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 1 Apr 2022
- 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 Any age
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adult patients with uncontrolled intraocular pressure
- on maximally tolerated medical treatment.
- Primary open angle glaucoma or neovascular glaucoma
Who cannot join
- patients with other types of glaucoma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of MicroPulse Transscleral Laser Cyclophotocoagulation With the Zig Zag Mode of Application in Adult Glaucomatous Patients
This is a prospective single-arm clinical trial in which patients with neovascular or primary open angle glaucoma with uncontrolled intraocular pressure (despite maximal tolerated anti-glaucoma medical treatment) were selected for micro-pulse trans-scleral cyclophotocoagulation using an MP3 handpiece with Iridex Cyclo G6 Laser settings (2000mW of 810 nm infrared diode laser set on micro-pulse delivery mode with 31.3 % duty cycle). The laser will be delivered over three quadrants for 90 seconds for each quadrant (total 270 sec) in Zigzag mode sparing the fourth quadrant for either further intervention or a previous surgery performed. Follow up examination (for at least 6 months) will include assessment of IOP in terms of percentage of IOP reduction and sustainability of results, BCVA, and the number of medications post-operatively.
Read the detailed description
From the expert opinion, using the ZigZag technique would increase the success rate by 10-20 %.
Type of study: Prospective single arm clinical trial. Participants: 24 eyes of 20 consecutive patients who underwent MP-TSCPC with Zig Zag technique at a private ophthalmology center from March 16,2021 to April 12,2021 and who had at least 6 months of follow-up were included.
All cases were performed in a specialized ophthalmic center in Cairo, Egypt by the same surgeon with the same technique and standardized parameters.
On presentation, proper history was taken from all patients including personal history, history of systemic illness, family history for glaucoma, past ocular history, history of current illness including onset, course, duration of disease, causes of progression and current medication.
Ophthalmic examinations included best corrected visual acuity, anterior segment, posterior segment, gonioscopy and measuring intraocular pressure.
Investigations performed included visual fields which although being important for diagnosis, they could not be done in the majority of cases as VA was severely affected as will be clarified in the results section, OCT optic nerve head, and measurement of central corneal thickness in addition to ocular ultrasonography if fundus could not be examined to detect the pathology and document the retinal condition.
All the data were documented to be compared to post-operative results as IOP reduction, complications and number of medications.
Surgical procedure:
All surgeries were done under peri-bulbar blockage with short duration anesthetic (2% lidocaine) with systemic sedation for ocular anesthesia and akinesia.
Lubricant gel was used to facilitate probe motion.
Micro-pulse TSCPC was done using an MP3 handpiece (IRIDEX, CYCLO G6 Glaucoma Laser System, Mountain View, CA) with Laser settings (2000-mW of 810-nm infrared diode laser set on micro-pulse delivery mode with 31.3 % duty cycle where on-cycle of 0.5-ms followed by off-cycle of 1-ms).
The laser was delivered in Zigzag pattern respecting the anatomy of cilliary body being 6mm in length, and the probe is formulated thus the fiber optic is projected for 0.7 mm with contact diameter of 600 µ placed 3 mm from the limbus, the idea is to cover the largest diameter of ciliary body and ciliary processes putting into consideration the normal variation in ciliary body length and position, so the probe is moved for 2 mm perpendicular to a line 3 mm circumferential to the limbus so as to cover the largest circumference of the area supposed to hinder the cilliary body over three quadrants for 90 seconds for each quadrant (total 270 sec) sparing the fourth quadrant for either further intervention or a previous surgery performed (in all cases the 2 inferior quadrants were treated in addition to superotemporal quadrant being more accessible for Zig Zag pattern sparing the superonasal quadrant for further inrtervention except if a previous glaucoma surgery was performed in supertemporal quadrant where the superonasal quadrant was treated).]
Follow up examination (for at least 6 months) included assessment of IOP in terms of percentage of IOP reduction and sustainability of results, BCVA, the number of medications post-operatively, and reported complications.
Success was defined as either maintaining an IOP of less than 21 mmHg or achieving a reduction of 30% from baseline IOP with or without supplementing topical anti-glaucoma medications which was further classified as complete success where criteria of success were achieved without the need to add antiglaucoma medications, and qualified success where the antiglaucoma medications were needed to reach the target IOP
- Conditions
- Refractory Glaucoma
- Being tested
- micropulse transscleral cyclophotocoagulation
- 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 cyclophotocoagulationDevice
glaucomatous patients with uncontrolled intraocular pressure (despite maximal tolerated anti-glaucoma medical treatment) were selected for micro-pulse trans-scleral cyclophotocoagulation using an MP3 handpiece with Iridex Cyclo G6 Laser settings (2000mW of 810 nm infrared diode laser set on micro-pulse delivery mode with 31.3 % duty cycle). The laser will be delivered over three quadrants for 90 seconds for each quadrant (total 270 sec) in Zigzag mode sparing the fourth quadrant for either further intervention or a previous surgery performed. Follow up examination (for at least 6 months) will include assessment of IOP in terms of percentage of IOP reduction and sustainability of results, BCVA, and the number of medications post-operatively.
| Study group | Role | What they receive |
|---|---|---|
| Adult Glaucomatous patients with refractory glaucoma | Experimental | Adult glaucomatous patients with uncontrolled intraocular pressure despite maximal tolerated medical treatment Receives: Device: micropulse transscleral cyclophotocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the of intraocular pressure (in mmHg) using Goldman applanation tonometer to calculate the percentage of reduction.
Intraocular pressure will be measured in (mmHg) using Goldman applanation tonometer (an instrument that is based on Imbert-Fick law. It is considered to be the gold standard instrument for measurement of Intraocular pressure (IOP).It was named after Austrian-Swiss ophthalmologist Hans Goldmann ) before the procedure then measured in the 1 week follow up , 1 month , 3 months and 6 months follow up where each measure will be divided by the preoperative IOP to calculate the percentage of intra ocular pressure reduction and monitor the stability of IOP.
the success rate will be calculated depending on the rate of IOP reduction in the last follow up.
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 posted30 Aug 2022
- Study start1 Mar 2021
- Primary completion1 Mar 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Samy Abohussein, Helwan University
- Investigators
- TareK Aboulnasr, MD, Study director, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521334
- Sponsor's protocol ID
- Ahmed Sami Ahmed
- Status last verified
- Aug 2022
- First submitted
- 3 Aug 2022
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of MicroPulse Transscleral Laser Cyclophotocoagulation With the Zig Zag Mode of Application in Adult Glaucomatous Patients
- ClinicalTrials.gov ID
- NCT05521334
- Acronym / sponsor ID
- Ahmed Sami Ahmed
- Conditions
- Refractory Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 30 Aug 2022 (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 is a prospective single-arm clinical trial in which patients with neovascular or primary open angle glaucoma with uncontrolled intraocular pressure (despite maximal tolerated anti-glaucoma medical treatment) were selected for micro-pulse trans-scleral cyclophotocoagulation using an MP3 handpiece with Iridex Cyclo G6 Laser settings (2000mW of 810 nm infrared diode laser set on micro-pulse delivery mode with 31.3 % duty cycle). The laser will be delivered over three quadrants for 90 seconds for each quadrant (total 270 sec) in Zigzag mode sparing the fourth quadrant for either further intervention or a previous surgery performed. Follow up examination (for at least 6 months) will include assessment of IOP in terms of percentage of IOP reduction and sustainability of results, BCVA, and the number of medications post-operatively.
Detailed description
From the expert opinion, using the ZigZag technique would increase the success rate by 10-20 %.
Type of study: Prospective single arm clinical trial. Participants: 24 eyes of 20 consecutive patients who underwent MP-TSCPC with Zig Zag technique at a private ophthalmology center from March 16,2021 to April 12,2021 and who had at least 6 months of follow-up were included.
All cases were performed in a specialized ophthalmic center in Cairo, Egypt by the same surgeon with the same technique and standardized parameters.
On presentation, proper history was taken from all patients including personal history, history of systemic illness, family history for glaucoma, past ocular history, history of current illness including onset, course, duration of disease, causes of progression and current medication.
Ophthalmic examinations included best corrected visual acuity, anterior segment, posterior segment, gonioscopy and measuring intraocular pressure.
Investigations performed included visual fields which although being important for diagnosis, they could not be done in the majority of cases as VA was severely affected as will be clarified in the results section, OCT optic nerve head, and measurement of central corneal thickness in addition to ocular ultrasonography if fundus could not be examined to detect the pathology and document the retinal condition.
All the data were documented to be compared to post-operative results as IOP reduction, complications and number of medications.
Surgical procedure:
All surgeries were done under peri-bulbar blockage with short duration anesthetic (2% lidocaine) with systemic sedation for ocular anesthesia and akinesia.
Lubricant gel was used to facilitate probe motion.
Micro-pulse TSCPC was done using an MP3 handpiece (IRIDEX, CYCLO G6 Glaucoma Laser System, Mountain View, CA) with Laser settings (2000-mW of 810-nm infrared diode laser set on micro-pulse delivery mode with 31.3 % duty cycle where on-cycle of 0.5-ms followed by off-cycle of 1-ms).
The laser was delivered in Zigzag pattern respecting the anatomy of cilliary body being 6mm in length, and the probe is formulated thus the fiber optic is projected for 0.7 mm with contact diameter of 600 µ placed 3 mm from the limbus, the idea is to cover the largest diameter of ciliary body and ciliary processes putting into consideration the normal variation in ciliary body length and position, so the probe is moved for 2 mm perpendicular to a line 3 mm circumferential to the limbus so as to cover the largest circumference of the area supposed to hinder the cilliary body over three quadrants for 90 seconds for each quadrant (total 270 sec) sparing the fourth quadrant for either further intervention or a previous surgery performed (in all cases the 2 inferior quadrants were treated in addition to superotemporal quadrant being more accessible for Zig Zag pattern sparing the superonasal quadrant for further inrtervention except if a previous glaucoma surgery was performed in supertemporal quadrant where the superonasal quadrant was treated).]
Follow up examination (for at least 6 months) included assessment of IOP in terms of percentage of IOP reduction and sustainability of results, BCVA, the number of medications post-operatively, and reported complications.
Success was defined as either maintaining an IOP of less than 21 mmHg or achieving a reduction of 30% from baseline IOP with or without supplementing topical anti-glaucoma medications which was further classified as complete success where criteria of success were achieved without the need to add antiglaucoma medications, and qualified success where the antiglaucoma medications were needed to reach the target IOP
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Glaucomatous patients with refractory glaucoma | Experimental | Device: micropulse transscleral cyclophotocoagulationAdult glaucomatous patients with uncontrolled intraocular pressure despite maximal tolerated medical treatment |
Who may qualify
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients with uncontrolled intraocular pressure
- on maximally tolerated medical treatment.
- Primary open angle glaucoma or neovascular glaucoma
Key exclusion criteria (1 listed)
- patients with other types of glaucoma.
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 cyclophotocoagulationglaucomatous patients with uncontrolled intraocular pressure (despite maximal tolerated anti-glaucoma medical treatment) were selected for micro-pulse trans-scleral cyclophotocoagulation using an MP3 handpiece with Iridex Cyclo G6 Laser settings (2000mW of 810 nm infrared diode laser set on micro-pulse delivery mode with 31.3 % duty cycle). The laser will be delivered over three quadrants for 90 seconds for each quadrant (total 270 sec) in Zigzag mode sparing the fourth quadrant for either further intervention or a previous surgery performed. Follow up examination (for at least 6 months) will include assessment of IOP in terms of percentage of IOP reduction and sustainability of results, BCVA, and the number of medications post-operatively. | Device | Adult Glaucomatous patients with refractory glaucoma |
Primary outcome
Measuring the of intraocular pressure (in mmHg) using Goldman applanation tonometer to calculate the percentage of reduction.
Time frame: 6 months
Intraocular pressure will be measured in (mmHg) using Goldman applanation tonometer (an instrument that is based on Imbert-Fick law. It is considered to be the gold standard instrument for measurement of Intraocular pressure (IOP).It was named after Austrian-Swiss ophthalmologist Hans Goldmann ) before the procedure then measured in the 1 week follow up , 1 month , 3 months and 6 months follow up where each measure will be divided by the preoperative IOP to calculate the percentage of intra ocular pressure reduction and monitor the stability of IOP. the success rate will be calculated depending on the rate of IOP reduction in the last follow up.
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 30 Aug 2022.
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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.
TareK Aboulnasr, MD study director
Benha University
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 in people with Refractory Glaucoma, run by Helwan University at 1 site in Egypt.
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 3 inclusion and 1 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 30 Aug 2022. 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 Egypt. 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?
Measuring the of intraocular pressure (in mmHg) using Goldman applanation tonometer to calculate the percentage of reduction. (time frame: 6 months). 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 30 Aug 2022; AzTrials last refreshed its copy on 2 Nov 2026.