Glaucoma, Open-AngleNCT04215575
Baerveldt (BGI) Valve Versus Ahmed(AGV) Valve in Management of Difficult Glaucoma Cases
A study testing glaucoma implant procedure (Baerveldt) and glaucoma implant procedure (Ahmed) in people with Glaucoma, Open-Angle and Glaucoma Secondary, run by Ain Shams University.
Trial summary
Refractory glaucoma is a difficult subject as many glaucoma devices attempt to reduce IOP. Baerveldt implant is considered as a large implant, and, on the contrary, Ahmed implant is considered a small implant as many comparisons have showed. Investigators have previously used two models S2 and FP7 Ahmed implant. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Glaucoma, Open-Angle, Glaucoma Secondary, Glaucoma, Neovascular
- What is being tested?
- glaucoma implant procedure (Baerveldt) and glaucoma implant procedure (Ahmed)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 20 Dec 2016
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1 - patients with glaucoma who underwent a previous failed trabeculectomy or other intraocular surgery.
- 2- patients who had secondary glaucoma and are known to have a high failure rate with trabeculectomy such as neovascular, uveitis, or iridocorneal endothelial syndrome-associated glaucoma, were included in the study.
Who cannot join
- 1 - patients lacked light perception, unwilling or unable to give informed consent, were expected to be unavailable for follow-up visits.
- 2-had previous aqueous shunt implanted in the same eye, other external impediment to supero-temporal drainage device implantation.
- 3- presence of silicone oil, vitreous in the anterior chamber sufficient to require a vitrectomy.
- 4-uveitis associated with a systemic condition like juvenile rheumatoid arthritis, nanophthalmos, Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure.
About this study
Official title: Baerveldt Glaucoma Implant Versus Ahmed Glaucoma Implant in One- Year Follow up, Comparative Study
Refractory glaucoma is a difficult subject as many glaucoma devices attempt to reduce IOP. Baerveldt implant is considered as a large implant, and, on the contrary, Ahmed implant is considered a small implant as many comparisons have showed. Investigators have previously used two models S2 and FP7 Ahmed implant. Currently, investigators use Baerveldt implant in refractory glaucoma cases in order to compare it with the Ahmed implant.
Read the detailed description
Eighty-one participants with glaucoma after ocular surgery or secondary glaucoma with persistent and uncontrolled IOP > 21 mmHg were randomized for placement of Baerveldt implant or Ahmed implant models using a standardized surgical technique.
The primary outcome was failure, which was defined as IOP >16 mmHg with glaucoma medication on 2 consecutive study visits. Secondary outcomes were IOP, medication use, visual acuity, complications, and interventions.
- Being tested
- glaucoma implant procedure (Baerveldt), glaucoma implant procedure (Ahmed)
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma, Neovascular, Glaucoma, Angle-Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glaucoma implant procedure (Baerveldt)Device
Also called glaucoma valve surgery
A 350 mm2 Baerveldt glaucoma implant was placed in the superotemporal quadrant in 25 patients randomized to BGI group. A limbus-based conjunctival flap was dissected, and the implant was sutured to sclera 10 mm posterior to the limbus. A scleral graft was used to cover the limbal portion of the tube, and the conjunctiva was closed.
glaucoma implant procedure (Ahmed)Device
Also called glaucoma valve surgery
A 184 mm2 Ahmed glaucoma implant was placed in the superotemporal quadrant in 56 patients randomized to AGV group. A fornix-based conjunctival flap was dissected, and the implant was sutured to sclera 10 mm posterior to the limbus. The Ahmed tube left patent and viscoelastic substance injected into anterior chamber. A scleral graft was used to cover the limbal portion of the tube, and the conjunctiva was closed.
| Study group | Role | What they receive |
|---|---|---|
| BGI model 101-350 placement (BGI group) | Active comparator | A 350 mm2 Baerveldt glaucoma implant was placed. Follow-up visits were scheduled 1 day, 1 week, 1 month, 3 months, 6 months, 1 year postoperatively. The primary outcome measure was failure that defined as IOP >16 mmHg or less than a 20% reduction below baseline on 2 consecutive study visits.The IOP, the use of glaucoma medications, visual acuity (VA), visual fields, bleb morphology and rates of surgical complications were secondary outcome measures. Receives: Device: glaucoma implant procedure (Baerveldt) |
| AGV model FP7 or S2 placement (AGV group) | Experimental | A 184 mm2 Ahmed glaucoma implant was placed. Follow-up visits were scheduled 1 day, 1 week, 1 month, 3 months, 6 months, 1 year postoperatively. The primary outcome measure was failure that defined as IOP >16 mmHg or less than a 20% reduction below baseline on 2 consecutive study visits. The IOP, the use of glaucoma medications, visual acuity (VA), visual fields, bleb morphology and rates of surgical complications were secondary outcome measures Receives: Device: glaucoma implant procedure (Ahmed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP
mean IOPs
Measured: one year follow up
glaucoma medications
mean number of glaucoma medications
Measured: one year follow up
Secondary outcomes (1)
visual acuity
log MAR Snellen median and interquartile Range values
Measured: one year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start1 Jan 2014
- Primary completion1 Dec 2016
- Study completion20 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized to BGI model 101-350 placement (BGI group) or an AGV model FP7or S2 placement (AGV group). Follow-up visits were scheduled 1 day, 1 week, 1 month, 3 months, 6 months, 1 year postoperatively. The primary outcome measure was failure that defined as IOP \>16 mmHg or less than a 20% reduction below baseline on 2 consecutive study visits.The IOP, the use of glaucoma medications, visual acuity (VA), visual fields, bleb morphology and rates of surgical complications were secondary outcome measures.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, khaled hamdi elbaklish, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215575
- Sponsor's protocol ID
- FWA000017585 FMASU21/2017
- Status last verified
- Dec 2019
- First submitted
- 29 Dec 2019
- Last updated
- 3 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no actual plan
Publications
Elbaklish KH, Saleh SM, Gomaa WA. Baerveldt Glaucoma Implant versus Ahmed Glaucoma Implant in a One-Year Follow Up, Comparative Study. Clin Ophthalmol. 2020 Jan 8;14:29-39. doi: 10.2147/OPTH.S224654. eCollection 2020.
PubMed 32021066
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baerveldt Glaucoma Implant Versus Ahmed Glaucoma Implant in One- Year Follow up, Comparative Study
- ClinicalTrials.gov ID
- NCT04215575
- Acronym / sponsor ID
- FWA000017585 FMASU21/2017
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 20 Dec 2016 (actual)
- First posted
- 2 Jan 2020 (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.
Refractory glaucoma is a difficult subject as many glaucoma devices attempt to reduce IOP. Baerveldt implant is considered as a large implant, and, on the contrary, Ahmed implant is considered a small implant as many comparisons have showed. Investigators have previously used two models S2 and FP7 Ahmed implant. Currently, investigators use Baerveldt implant in refractory glaucoma cases in order to compare it with the Ahmed implant.
Detailed description
Eighty-one participants with glaucoma after ocular surgery or secondary glaucoma with persistent and uncontrolled IOP > 21 mmHg were randomized for placement of Baerveldt implant or Ahmed implant models using a standardized surgical technique.
The primary outcome was failure, which was defined as IOP >16 mmHg with glaucoma medication on 2 consecutive study visits. Secondary outcomes were IOP, medication use, visual acuity, complications, and interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants were randomized to BGI model 101-350 placement (BGI group) or an AGV model FP7or S2 placement (AGV group). Follow-up visits were scheduled 1 day, 1 week, 1 month, 3 months, 6 months, 1 year postoperatively. The primary outcome measure was failure that defined as IOP >16 mmHg or less than a 20% reduction below baseline on 2 consecutive study visits.The IOP, the use of glaucoma medications, visual acuity (VA), visual fields, bleb morphology and rates of surgical complications were secondary outcome measures.
| Arm | Type | Receives |
|---|---|---|
| BGI model 101-350 placement (BGI group) | Active comparator | Device: glaucoma implant procedure (Baerveldt)A 350 mm2 Baerveldt glaucoma implant was placed. Follow-up visits were scheduled 1 day, 1 week, 1 month, 3 months, 6 months, 1 year postoperatively. The primary outcome measure was failure that defined as IOP >16 mmHg or less than a 20% reduction below baseline on 2 consecutive study visits.The IOP, the use of glaucoma medications, visual acuity (VA), visual fields, bleb morphology and rates of surgical complications were secondary outcome measures. |
| AGV model FP7 or S2 placement (AGV group) | Experimental | Device: glaucoma implant procedure (Ahmed)A 184 mm2 Ahmed glaucoma implant was placed. Follow-up visits were scheduled 1 day, 1 week, 1 month, 3 months, 6 months, 1 year postoperatively. The primary outcome measure was failure that defined as IOP >16 mmHg or less than a 20% reduction below baseline on 2 consecutive study visits. The IOP, the use of glaucoma medications, visual acuity (VA), visual fields, bleb morphology and rates of surgical complications were secondary outcome measures |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1 - patients with glaucoma who underwent a previous failed trabeculectomy or other intraocular surgery.
- 2- patients who had secondary glaucoma and are known to have a high failure rate with trabeculectomy such as neovascular, uveitis, or iridocorneal endothelial syndrome-associated glaucoma, were included in the study.
Key exclusion criteria (4 listed)
- 1 - patients lacked light perception, unwilling or unable to give informed consent, were expected to be unavailable for follow-up visits.
- 2-had previous aqueous shunt implanted in the same eye, other external impediment to supero-temporal drainage device implantation.
- 3- presence of silicone oil, vitreous in the anterior chamber sufficient to require a vitrectomy.
- 4-uveitis associated with a systemic condition like juvenile rheumatoid arthritis, nanophthalmos, Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure.
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 |
|---|---|---|
| glaucoma implant procedure (Baerveldt)Also: glaucoma valve surgeryA 350 mm2 Baerveldt glaucoma implant was placed in the superotemporal quadrant in 25 patients randomized to BGI group. A limbus-based conjunctival flap was dissected, and the implant was sutured to sclera 10 mm posterior to the limbus. A scleral graft was used to cover the limbal portion of the tube, and the conjunctiva was closed. | Device | BGI model 101-350 placement (BGI group) |
| glaucoma implant procedure (Ahmed)Also: glaucoma valve surgeryA 184 mm2 Ahmed glaucoma implant was placed in the superotemporal quadrant in 56 patients randomized to AGV group. A fornix-based conjunctival flap was dissected, and the implant was sutured to sclera 10 mm posterior to the limbus. The Ahmed tube left patent and viscoelastic substance injected into anterior chamber. A scleral graft was used to cover the limbal portion of the tube, and the conjunctiva was closed. | Device | AGV model FP7 or S2 placement (AGV group) |
Primary outcome
IOP
Time frame: one year follow up
mean IOPs
glaucoma medications
Time frame: one year follow up
mean number of glaucoma medications
1 secondary outcome
visual acuity
Time frame: one year 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 3 Jan 2020.
- Derived from this study: PubMed 32021066Elbaklish KH, Saleh SM, Gomaa WA. Baerveldt Glaucoma Implant versus Ahmed Glaucoma Implant in a One-Year Follow Up, Comparative Study. Clin Ophthalmol. 2020 Jan 8;14:29-39. doi: 10.2147/OPTH.S224654. eCollection 2020.
- Individual participant dataSharing planned: No. no actual plan
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing glaucoma implant procedure (Baerveldt) and glaucoma implant procedure (Ahmed) in people with Glaucoma, Open-Angle and Glaucoma Secondary, run by Ain Shams University.
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 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 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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 (time frame: one year follow up). 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?
On the ClinicalTrials.gov record for NCT04215575, which also lists 1 linked publication.
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 3 Jan 2020.