Refractory GlaucomaNCT04921098
CPC in Adult Refractory Glaucoma
A study testing Diode Laser Cyclophotocoagulation in people with Refractory Glaucoma, run by Sohag University at 1 site in Egypt.
Trial summary
The purpose of this study is to assess the relative effectiveness and safety of diode laser cyclophotocoagulation procedure to reduce IOP and relieve pain in adult patients with refractory glaucoma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractory Glaucoma
- What is being tested?
- Diode Laser Cyclophotocoagulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2021to 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with refractory glaucoma aging 18 years and older.
- Both sexes are included.
- Patients Capable of giving informed consent.
- Pseudophkic glaucoma.
- Aphakic glaucoma.
- Silicon oil induced glaucoma.
- Neovascular glaucoma.
- Inflammatory glaucoma.
Who cannot join
- Patients <18 years of age.
- Patients controlled on regular antiglaucomatous therapy.
- Patients who cannot do regular follow up visits.
- Diffuse scleral staphyloma at the site of CPC.
Trial locations and contacts
1 site in 1 country.
Ismail M Abdellatif, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University
Sohag
Osama R Elsherif, Professor
About this study
Official title: Evaluation of Diode Laser Cyclophotocoagulation in Adult Refractory Glaucoma
The purpose of this study is to assess the relative effectiveness and safety of diode laser cyclophotocoagulation procedure to reduce IOP and relieve pain in adult patients with refractory glaucoma.
Read the detailed description
A hospital -based, prospective interventional non comparative case series study.This study will be conducted on patients with refractory glaucoma whose ages are 18 years and older.They will be subjected to Transscleral Diode Laser Cyclophotocoagulation.
Postoperative evaluation will be scheduled for the first day postoperative, then 1 week later and then at 1st, 3rd, month postoperative.
- Conditions
- Refractory Glaucoma
- Being tested
- Diode Laser Cyclophotocoagulation
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diode Laser CyclophotocoagulationProcedure or surgery
A handpiece (G probe) is used to deliver the diode laser energy with a wavelength of 810 nm.
| Study group | Role | What they receive |
|---|---|---|
| Refractory glaucoma | Experimental | Not described Receives: Procedure: Diode Laser Cyclophotocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in intraocular pressure
IOP measuring using Goldmann applanation tonometer.
Measured: First day postoperative and 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start1 Jul 2021
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Abdelmalek Besada, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921098
- Sponsor's protocol ID
- Soh-Med-21-05-01
- Status last verified
- Jan 2022
- First submitted
- 30 May 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ansari E, Gandhewar J. Long-term efficacy and visual acuity following transscleral diode laser photocoagulation in cases of refractory and non-refractory glaucoma. Eye (Lond). 2007 Jul;21(7):936-40. doi: 10.1038/sj.eye.6702345. Epub 2006 Apr 21.
PubMed 16628239Lai JS, Tham CC, Chan JC, Lam DS. Diode laser transscleral cyclophotocoagulation in the treatment of chronic angle-closure glaucoma: a preliminary study. J Glaucoma. 2003 Aug;12(4):360-4. doi: 10.1097/00061198-200308000-00011.
PubMed 12897582Nassiri N, Kamali G, Rahnavardi M, Mohammadi B, Nassiri S, Rahmani L, Nassiri N. Ahmed glaucoma valve and single-plate Molteno implants in treatment of refractory glaucoma: a comparative study. Am J Ophthalmol. 2010 Jun;149(6):893-902. doi: 10.1016/j.ajo.2010.01.025. Epub 2010 May 8.
PubMed 20451896
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diode Laser Cyclophotocoagulation in Adult Refractory Glaucoma
- ClinicalTrials.gov ID
- NCT04921098
- Acronym / sponsor ID
- Soh-Med-21-05-01
- Conditions
- Refractory Glaucoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 10 Jun 2021 (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 purpose of this study is to assess the relative effectiveness and safety of diode laser cyclophotocoagulation procedure to reduce IOP and relieve pain in adult patients with refractory glaucoma.
Detailed description
A hospital -based, prospective interventional non comparative case series study.This study will be conducted on patients with refractory glaucoma whose ages are 18 years and older.They will be subjected to Transscleral Diode Laser Cyclophotocoagulation.
Postoperative evaluation will be scheduled for the first day postoperative, then 1 week later and then at 1st, 3rd, month postoperative.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Refractory glaucoma | Experimental | Procedure: Diode Laser Cyclophotocoagulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
Key exclusion criteria (4 listed)
- Patients <18 years of age.
- Patients controlled on regular antiglaucomatous therapy.
- Patients who cannot do regular follow up visits.
- Diffuse scleral staphyloma at the site of CPC.
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 |
|---|---|---|
| Diode Laser CyclophotocoagulationA handpiece (G probe) is used to deliver the diode laser energy with a wavelength of 810 nm. | Procedure or surgery | Refractory glaucoma |
Primary outcome
change in intraocular pressure
Time frame: First day postoperative and 1 week
IOP measuring using Goldmann applanation tonometer.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Background: PubMed 16628239Ansari E, Gandhewar J. Long-term efficacy and visual acuity following transscleral diode laser photocoagulation in cases of refractory and non-refractory glaucoma. Eye (Lond). 2007 Jul;21(7):936-40. doi: 10.1038/sj.eye.6702345. Epub 2006 Apr 21.
- Background: PubMed 12897582Lai JS, Tham CC, Chan JC, Lam DS. Diode laser transscleral cyclophotocoagulation in the treatment of chronic angle-closure glaucoma: a preliminary study. J Glaucoma. 2003 Aug;12(4):360-4. doi: 10.1097/00061198-200308000-00011.
- Background: PubMed 20451896Nassiri N, Kamali G, Rahnavardi M, Mohammadi B, Nassiri S, Rahmani L, Nassiri N. Ahmed glaucoma valve and single-plate Molteno implants in treatment of refractory glaucoma: a comparative study. Am J Ophthalmol. 2010 Jun;149(6):893-902. doi: 10.1016/j.ajo.2010.01.025. Epub 2010 May 8.
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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.
Ismail M Abdellatif, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diode Laser Cyclophotocoagulation in people with Refractory Glaucoma, run by Sohag 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 8 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: status not confirmed, as of the sponsor's last update on 11 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mina A Besada, Resident (01280899267, mena011205@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in intraocular pressure (time frame: First day postoperative and 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04921098, which also lists 3 linked publications.
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 11 Jan 2022.