Congenital GlaucomaPhase 1NCT01460017
Comparison Between Deep Sclerectomy and Traditional Trabeculotomy & Trabeculectomy in Congenital Glaucoma
A Phase 1 study testing Deep Sclerectomy and Combined Trab in people with Congenital Glaucoma, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
The investigators hypothesize that deep sclerectomy in congenital glaucoma is a safer procedure and may yield better results than trabeculotomy trabeculectomy approach. Read more about this study
- Who is it for?
- Ages 1 day to 12 years
- Conditions the study is for
- Congenital Glaucoma
- What is being tested?
- Deep Sclerectomy and Combined Trab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Nov 2011to Dec 2013
- Phase
- Phase 1
- 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 1 day to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Any case diagnosed as congenital glaucoma with enlarged corneal diameter more than 11 mm and intra-ocular pressure above 21 mmHg, including corneal edema or Habb's Stria with or without optic disc cupping.
- Any case diagnosed as primary or secondary congenital glaucoma to ocular or systemic abnormalities.
- Within the age of (0 - 12).
Who cannot join
- Cases of congenital glaucoma with previous intervention.
- Age above 12 Yrs.
- Cases with secondary glaucoma caused by surgical intervention, ocular co-morbidity, medications or trauma
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Abdul Aziz University Hospital
Riyadh, Riyadh Region, 11411
Saleh A. Al-Obeidan, MD, +96614786100 ext. 1425, alobeidan@yahoo.com
Essam A. Osman, FRCS, +966507449080, essam.osman065@gmail.com
About this study
Official title: Comparison Between The Outcome of Deep Sclerectomy and Traditional Trabeculotomy and Trabeculectomy Surgeries in Congenital Glaucoma
The investigators hypothesize that deep sclerectomy in congenital glaucoma is a safer procedure and may yield better results than trabeculotomy trabeculectomy approach.
Read the detailed description
Non penetrating glaucoma surgery depends on filtration through trabeculo-descmeto window as well as supra-choroidal space less to sub-conjunctival rout. the nature of the operation keeps the globe intact without penetration that leads to less complications compared to penetrating trabeculectomy combined with trabeculotomy.
- Conditions
- Congenital Glaucoma
- Being tested
- Deep Sclerectomy, Combined Trab
- Medical subject headings
- Hydrophthalmos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep SclerectomyProcedure or surgery
Also called Non penetrating DS
Non penetrating glaucoma surgery is a new procedure in adults that has less post operative complications with good results, it is to be applied in children.
Combined TrabProcedure or surgery
Also called Combined Trabeculectomy Trabeculotomy
Combined trabeculectomy and trabeculotomy is a standard surgery for congenital glaucoma, however, it has its known complications.
| Study group | Role | What they receive |
|---|---|---|
| DS arm | Active comparator | Deep sclerectomy surgery will be conduct in this arm Receives: Procedure: Deep Sclerectomy |
| Trab arm | Active comparator | combined Trabeculectomy and Trabeculotomy surgery will be conducted in this arm Receives: Procedure: Combined Trab |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in IOP
decrease in the intraocular pressure to the normal limit (<22 - >6) mmHg
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ahmed Mousa, King Saud University
- Investigators
- Saleh A. Al-Obeidan, MD, Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01460017
- Sponsor's protocol ID
- E-11-487
- Status last verified
- Oct 2011
- First submitted
- 25 Oct 2011
- Last updated
- 26 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between The Outcome of Deep Sclerectomy and Traditional Trabeculotomy and Trabeculectomy Surgeries in Congenital Glaucoma
- ClinicalTrials.gov ID
- NCT01460017
- Acronym / sponsor ID
- E-11-487
- Conditions
- Congenital Glaucoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 26 Oct 2011 (estimated)
- 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 investigators hypothesize that deep sclerectomy in congenital glaucoma is a safer procedure and may yield better results than trabeculotomy trabeculectomy approach.
Detailed description
Non penetrating glaucoma surgery depends on filtration through trabeculo-descmeto window as well as supra-choroidal space less to sub-conjunctival rout. the nature of the operation keeps the globe intact without penetration that leads to less complications compared to penetrating trabeculectomy combined with trabeculotomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DS arm | Active comparator | Procedure: Deep SclerectomyDeep sclerectomy surgery will be conduct in this arm |
| Trab arm | Active comparator | Procedure: Combined Trabcombined Trabeculectomy and Trabeculotomy surgery will be conducted in this arm |
Who may qualify
- Ages
- 1 day to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Any case diagnosed as congenital glaucoma with enlarged corneal diameter more than 11 mm and intra-ocular pressure above 21 mmHg, including corneal edema or Habb's Stria with or without optic disc cupping.
- Any case diagnosed as primary or secondary congenital glaucoma to ocular or systemic abnormalities.
- Within the age of (0 - 12).
Key exclusion criteria (3 listed)
- Cases of congenital glaucoma with previous intervention.
- Age above 12 Yrs.
- Cases with secondary glaucoma caused by surgical intervention, ocular co-morbidity, medications or trauma
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 |
|---|---|---|
| Deep SclerectomyAlso: Non penetrating DSNon penetrating glaucoma surgery is a new procedure in adults that has less post operative complications with good results, it is to be applied in children. | Procedure or surgery | DS arm |
| Combined TrabAlso: Combined Trabeculectomy TrabeculotomyCombined trabeculectomy and trabeculotomy is a standard surgery for congenital glaucoma, however, it has its known complications. | Procedure or surgery | Trab arm |
Primary outcome
reduction in IOP
Time frame: 6 month
decrease in the intraocular pressure to the normal limit (<22 - >6) mmHg
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2011.
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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.
Saleh A. Al-Obeidan, MD principal investigator
King Saud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Deep Sclerectomy and Combined Trab in people with Congenital Glaucoma, run by King Saud University at 1 site in Saudi Arabia.
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 3 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 26 Oct 2011. 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 Saudi Arabia. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction in IOP (time frame: 6 month). 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 26 Oct 2011.