GlaucomaNCT05299281
Micropulse Transscleral Diode Laser Cyclophotocoagulation (MP-TSCPC) as a Treatment Modality for Glaucoma Patients
A study testing Micropulse transscleral cyclophotocoagulation (MP-TSCPC) in people with Glaucoma, run by Benha University at 1 site in Egypt.
Trial summary
The study objective was to evaluate the efficacy and safety of transscleral cyclophotocoagulation (TSCPC) using micropulse diode laser treatment in patients with various types of glaucoma. Read more about this study
- Who is it for?
- Ages 3 to 70 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Micropulse transscleral cyclophotocoagulation (MP-TSCPC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 1 Jul 2021
- 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 3 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients previously diagnosed with glaucoma if they had uncontrolled Intraocular pressure despite maximal tolerated medical therapy.
- Patients who are unable to maintain compliance with the prescribed topical medications.
- Patients who need filtering glaucoma surgery for controlling Intraocular pressure but are not generally fit for the surgery.
- Patients who refused incisional procedures like subscleral trabeculectomy.
Who cannot join
- Patients who were unable to give informed consent.
- Patients who had undergone previous conventional transscleral diode laser cyclophotocoagulation (TSCPC).
- Patients with significant scleral thinning defined as thinning of more than one clock hour noticed on scleral transillumination.
- Patients with ongoing ocular infection or inflammation.
Trial locations and contacts
1 site in 1 country.
About this study
The study objective was to evaluate the efficacy and safety of transscleral cyclophotocoagulation (TSCPC) using micropulse diode laser treatment in patients with various types of glaucoma.
Read the detailed description
Evaluation of the efficacy and safety of a new form of transscleral cyclophotocoagulation (TSCPC) using micropulse diode laser treatment in patients with various types of glaucoma.
In this study, 810 nm infrared diode laser radiation in the micro- pulse mode was used in conjunction with a G probe (IRIDEX Medical Instruments, Mountain View, CA, USA).
The laser settings ranged from 2000- 2500 mW of 810 nm infrared diode laser set on micro- pulse mode, delivered over 100-200 seconds (envelope of micropulses) depending on severity of the case and other patient factors. With duty cycle 31.3% (This translates to 0.5 ms "on" time and 1.1 ms "off" time), which allows the tissue to cool down between laser shots, thus greatly reducing thermal damage.
- Conditions
- Glaucoma
- Being tested
- Micropulse transscleral cyclophotocoagulation (MP-TSCPC)
- 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 cyclophotocoagulation (MP-TSCPC)Device
patients undergone micropulse laser transscleral cyclophotocoagulation. The laser settings ranged from 2000- 2500 mW of 810 nm infrared diode laser radiation set on micro- pulse mode (Iris Medical Instruments, Mountain View, CA, USA), delivered over 100-200 s (envelope of micropulses) depending on severity of the case and other patient factors.
Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma patients | Other | Patients were enrolled from outpatient clinic with glaucoma during the period between January 2020 and July 2021 Receives: Device: Micropulse transscleral cyclophotocoagulation (MP-TSCPC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure (IOP)
significant change in IOP in mmHg.
Measured: Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively
best corrected visual acuity (BCVA)
change in BCVA using snellen's chart
Measured: Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively
Secondary outcomes (3)
complication rate.
Describing any complications related to the procedure.
Measured: Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively
change in number of postoperative glaucoma medications.
Number of postoperative glaucoma medications.
Measured: Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively
retreatment rate.
percentage of patients needing further treatment.
Measured: Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start1 Jan 2020
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
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.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gehad Hassan Abdelhalim Mohamed Youssef, Benha University
- Investigators
- Gehad H Youssef, Msc, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299281
- Sponsor's protocol ID
- MS 9-222
- Status last verified
- Mar 2022
- First submitted
- 9 Mar 2022
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micropulse Transscleral Diode Laser Cyclophotocoagulation (MP-TSCPC) as a Treatment Modality for Glaucoma Patients
- ClinicalTrials.gov ID
- NCT05299281
- Acronym / sponsor ID
- MS 9-222
- Conditions
- Glaucoma
- Keywords
- glaucoma, micropulse laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 29 Mar 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.
The study objective was to evaluate the efficacy and safety of transscleral cyclophotocoagulation (TSCPC) using micropulse diode laser treatment in patients with various types of glaucoma.
Detailed description
Evaluation of the efficacy and safety of a new form of transscleral cyclophotocoagulation (TSCPC) using micropulse diode laser treatment in patients with various types of glaucoma.
In this study, 810 nm infrared diode laser radiation in the micro- pulse mode was used in conjunction with a G probe (IRIDEX Medical Instruments, Mountain View, CA, USA).
The laser settings ranged from 2000- 2500 mW of 810 nm infrared diode laser set on micro- pulse mode, delivered over 100-200 seconds (envelope of micropulses) depending on severity of the case and other patient factors. With duty cycle 31.3% (This translates to 0.5 ms "on" time and 1.1 ms "off" time), which allows the tissue to cool down between laser shots, thus greatly reducing thermal damage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glaucoma patients | Other | Device: Micropulse transscleral cyclophotocoagulation (MP-TSCPC)Patients were enrolled from outpatient clinic with glaucoma during the period between January 2020 and July 2021 |
Who may qualify
- Ages
- 3 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients previously diagnosed with glaucoma if they had uncontrolled Intraocular pressure despite maximal tolerated medical therapy.
- Patients who are unable to maintain compliance with the prescribed topical medications.
- Patients who need filtering glaucoma surgery for controlling Intraocular pressure but are not generally fit for the surgery.
- Patients who refused incisional procedures like subscleral trabeculectomy.
Key exclusion criteria (4 listed)
- Patients who were unable to give informed consent.
- Patients who had undergone previous conventional transscleral diode laser cyclophotocoagulation (TSCPC).
- Patients with significant scleral thinning defined as thinning of more than one clock hour noticed on scleral transillumination.
- Patients with ongoing ocular infection or inflammation.
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 cyclophotocoagulation (MP-TSCPC)patients undergone micropulse laser transscleral cyclophotocoagulation. The laser settings ranged from 2000- 2500 mW of 810 nm infrared diode laser radiation set on micro- pulse mode (Iris Medical Instruments, Mountain View, CA, USA), delivered over 100-200 s (envelope of micropulses) depending on severity of the case and other patient factors. Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively. | Device | Glaucoma patients |
Primary outcome
Intraocular pressure (IOP)
Time frame: Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively
significant change in IOP in mmHg.
best corrected visual acuity (BCVA)
Time frame: Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively
change in BCVA using snellen's chart
3 secondary outcomes
complication rate.
Time frame: Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively
change in number of postoperative glaucoma medications.
Time frame: Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively
retreatment rate.
Time frame: Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively
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 29 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Glaucoma
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
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.
Gehad H Youssef, Msc principal investigator
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 (MP-TSCPC) in people with Glaucoma, run by Benha 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 4 inclusion and 4 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 29 Mar 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?
Intraocular pressure (IOP) (time frame: Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively). The study lists 2 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 29 Mar 2022.