GlaucomaNCT05231252
The Effect of Direct Cyclophotocoagulation Using Endolaser in Silicon Induced Glaucoma: a Pilot Study.
A study testing Cyclophotocoagulation in people with Glaucoma, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
Transcleral cyclophotocoagulation has been used to treat glaucoma secondary to silicone oil Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Cyclophotocoagulation
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 1 Jan 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- . Patients above 18 years of age. .Silicon filled for more than 2 months. .IOP more than 21 mmHg on triple topical antiglaucoma eye drops.
- Exclusion Criteria: . History of glaucoma prior to the initial retinal surgery. . Immediate rise of IOP after SOI. . History of previous laser application to the ciliary body. . Any contraindications for silicone oil removal.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Transcleral cyclophotocoagulation has been used to treat glaucoma secondary to silicone oil
- Conditions
- Glaucoma
- Being tested
- Cyclophotocoagulation
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophotocoagulationProcedure or surgery
Transcleral cyclophotocoagulation is used to treat glaucoma secondary to silicone oil.
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP lowering in patients with silicon induced glaucoma
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 Feb 2022
- Study start1 Jun 2021
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
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 Kafrelsheikh 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
- Non-randomised
- Intervention model
- Single group
- Model description
- pilot
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hashiem, Kafrelsheikh University
- Investigators
- Ahmed A.Mohamed, PhD, Study director, Ain Shams University,Faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231252
- Sponsor's protocol ID
- 27-12-22
- Status last verified
- Nov 2022
- First submitted
- 28 Jan 2022
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: will not be shared til manuscript publishment
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Direct Cyclophotocoagulation Using Endolaser in Silicon Induced Glaucoma: a Pilot Study.
- ClinicalTrials.gov ID
- NCT05231252
- Acronym / sponsor ID
- 27-12-22
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 9 Feb 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.
Transcleral cyclophotocoagulation has been used to treat glaucoma secondary to silicone oil
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- pilot
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- . Patients above 18 years of age. .Silicon filled for more than 2 months. .IOP more than 21 mmHg on triple topical antiglaucoma eye drops.
- Exclusion Criteria: . History of glaucoma prior to the initial retinal surgery. . Immediate rise of IOP after SOI. . History of previous laser application to the ciliary body. . Any contraindications for silicone oil removal.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| CyclophotocoagulationTranscleral cyclophotocoagulation is used to treat glaucoma secondary to silicone oil. | Procedure or surgery | – |
Primary outcome
IOP lowering in patients with silicon induced glaucoma
Time frame: 6 months
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 23 Nov 2022.
- Individual participant dataSharing planned: No. will not be shared til manuscript publishment
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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.
Ahmed A.Mohamed, PhD study director
Ain Shams University,Faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyclophotocoagulation in people with Glaucoma, run by Kafrelsheikh 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 2 inclusion and 0 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 23 Nov 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?
IOP lowering in patients with silicon induced glaucoma (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 23 Nov 2022.