GlaucomaNCT04417920
Express Implant Versus Trabeculectomy After Late Failure Trabeculectomy
A study testing Express implant device in people with Glaucoma, run by Menoufia University at 1 site in Egypt.
Trial summary
To compare between outcome of Express implant and subscleral trabeculectomy (SST) in management of glaucoma after previous trabeculectomy with a fibrotic bleb. Read more about this study
- Who is it for?
- Ages 42 to 55 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Express implant device
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2017to 20 May 2020
- 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 42 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- elevated intraocular pressure (IOP) with fibrotic bleb despite previous SST since more than 4 months
- follow up 12mo after the second surgery
Who cannot join
- SST failure other than fibrotic bleb were also excluded
- follow up less than 4mo after the first surgery, and those less than 12mo after the second surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Express Implant Versus Trabeculectomy in a Fibrotic Bleb With Late Failure After Previous Trabeculectomy
To compare between outcome of Express implant and subscleral trabeculectomy (SST) in management of glaucoma after previous trabeculectomy with a fibrotic bleb.
Read the detailed description
Trabeculectomy is the main glaucoma surgery. Despite the good decline in intraocular pressure (IOP) that occur rapidly after the procedure, there is still failure occurring due to progressive subconjunctival fibrosis, with associated increased IOP.
If the bleb is revived by needling with adjunctive 5-fluorouracil (5FU) and mitomycin C (MMC) that used intraoperatively for the majority of these cases , the associated rise in IOP was controlled if the revision occured early within the first three months after surgery. But less success occurred if the bleb revision was delayed.
If these interventions fail, alternative approaches include new augmented trabeculectomy or aqueous shunt implantation.
Express shunt allows aqueous to pass from anterior chamber to subconjunctival space like trabeculectomy .Express shunt is a non valved shunt, It has an advantage of less traumatic, less complications, low diffuse bleb and high success rate.
- Conditions
- Glaucoma
- Being tested
- Express implant device
- Keywords
- Express valve, Failed Trabeculectomy
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Express implant deviceProcedure or surgery
Also called Trabeculectomy with Mitomycin-C
Operative technique in group I (Express implant) was as in group II (trabeculectomy) except with no sclerectomy or peripheral iridectomy , the steps included conjunctival peritomy superior-temporally away from the site of the fibrotic bleb at 12 o'clock, placed on the episclera under the conjunctiva and Tenon's capsule for a contact time of 3 minutes, ,triangular scleral flap , scleral dissection forward to the clear cornea to allow exposure of scleral spur then creation of a pilot hole is fashioned using a sapphire blade (Alcon laboratories,USA) then Express shunt 3 mm long device and external diameter 400 microns was implanted followed by closure of scleral flap and conjunctiva.
While in group II, Trabeculectomy with Mitomycin-C was done in superior-temporal region away from the fibrotic bleb at 12 o, clock.
| Study group | Role | What they receive |
|---|---|---|
| group I (Express implant) | Active comparator | conjunctival peritomy superior-temporally away from the site of the fibrotic bleb at 12 o'clock, placed on the episclera under the conjunctiva and Tenon's capsule for a contact time of 3 minutes, ,triangular scleral flap , scleral dissection forward to the clear cornea to allow exposure of scleral spur then creation of a pilot hole is fashioned using a sapphire blade (Alcon laboratories,USA) then Express shunt 3 mm long device and external diameter 400 microns was implanted followed by closure of scleral flap and conjunctiva Receives: Procedure: Express implant device |
| group II (trabeculectomy) | Active comparator | Trabeculectomy with Mitomycin-C was done in superior-temporal region away from the fibrotic bleb at 12 o, clock.
conjunctival peritomy superior-temporally away from the site of the fibrotic bleb at 12 o'clock, placed on the episclera under the conjunctiva and Tenon's capsule for a contact time of 3 minutes, ,triangular scleral flap , scleral dissection forward to the clear cornea to allow exposure of scleral spur then creation of sclerectomy and peripheral iridectomy and closed scleral flab and conjunctiva by nylon 10/0 sutures Receives: Procedure: Express implant device |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of intra ocular pressure (IOP)
IOP measured with Goldmann applanation tonometry:
Complete success in IOP considered as IOP less than 20 mmHg without treatment and a qualified success in IOP considered as IOP less than 20 mmHg with medical treatment and a failure in IOP control considered if IOP more than or equal 20 mmHg after surgery
Measured: one year follow up
Secondary outcomes (3)
Visual acuity changes by Decimal
glaucoma changes follow up
Measured: one year follow up
Glaucomatous visual field (VF) changes in median deviation by decibels (dB)
glaucoma changes follow up
Measured: one year follow up
Changes in optic Cup-to-Disc ratio by Volk+90 non-contact lens
glaucoma changes follow up
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 posted5 Jun 2020
- Study start1 Jul 2017
- Primary completion1 May 2019
- Study completion20 May 2020
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 GlaucomaStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Alnagdy, Menoufia University
- Investigators
- Faried Wagdy, Prof., Study chair, Gamal Abd El Nasr st. - Shebin ElKoum - Menofia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417920
- Sponsor's protocol ID
- late failure trabeculectomy
- Status last verified
- Jun 2020
- First submitted
- 21 May 2020
- Last updated
- 5 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Park J, Rittiphairoj T, Wang X, E JY, Bicket AK. Device-modified trabeculectomy for glaucoma. Cochrane Database Syst Rev. 2023 Mar 13;3(3):CD010472. doi: 10.1002/14651858.CD010472.pub3.
PubMed 36912740
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Express Implant Versus Trabeculectomy in a Fibrotic Bleb With Late Failure After Previous Trabeculectomy
- ClinicalTrials.gov ID
- NCT04417920
- Acronym / sponsor ID
- late failure trabeculectomy
- Conditions
- Glaucoma
- Keywords
- Express valve, Failed Trabeculectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 5 Jun 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.
To compare between outcome of Express implant and subscleral trabeculectomy (SST) in management of glaucoma after previous trabeculectomy with a fibrotic bleb.
Detailed description
Trabeculectomy is the main glaucoma surgery. Despite the good decline in intraocular pressure (IOP) that occur rapidly after the procedure, there is still failure occurring due to progressive subconjunctival fibrosis, with associated increased IOP.
If the bleb is revived by needling with adjunctive 5-fluorouracil (5FU) and mitomycin C (MMC) that used intraoperatively for the majority of these cases , the associated rise in IOP was controlled if the revision occured early within the first three months after surgery. But less success occurred if the bleb revision was delayed.
If these interventions fail, alternative approaches include new augmented trabeculectomy or aqueous shunt implantation.
Express shunt allows aqueous to pass from anterior chamber to subconjunctival space like trabeculectomy .Express shunt is a non valved shunt, It has an advantage of less traumatic, less complications, low diffuse bleb and high success rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group I (Express implant) | Active comparator | Procedure: Express implant deviceconjunctival peritomy superior-temporally away from the site of the fibrotic bleb at 12 o'clock, placed on the episclera under the conjunctiva and Tenon's capsule for a contact time of 3 minutes, ,triangular scleral flap , scleral dissection forward to the clear cornea to allow exposure of scleral spur then creation of a pilot hole is fashioned using a sapphire blade (Alcon laboratories,USA) then Express shunt 3 mm long device and external diameter 400 microns was implanted followed by closure of scleral flap and conjunctiva |
| group II (trabeculectomy) | Active comparator | Procedure: Express implant deviceTrabeculectomy with Mitomycin-C was done in superior-temporal region away from the fibrotic bleb at 12 o, clock. conjunctival peritomy superior-temporally away from the site of the fibrotic bleb at 12 o'clock, placed on the episclera under the conjunctiva and Tenon's capsule for a contact time of 3 minutes, ,triangular scleral flap , scleral dissection forward to the clear cornea to allow exposure of scleral spur then creation of sclerectomy and peripheral iridectomy and closed scleral flab and conjunctiva by nylon 10/0 sutures |
Who may qualify
- Ages
- 42 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- elevated intraocular pressure (IOP) with fibrotic bleb despite previous SST since more than 4 months
- follow up 12mo after the second surgery
Key exclusion criteria (2 listed)
- SST failure other than fibrotic bleb were also excluded
- follow up less than 4mo after the first surgery, and those less than 12mo after the second surgery
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 |
|---|---|---|
| Express implant deviceAlso: Trabeculectomy with Mitomycin-COperative technique in group I (Express implant) was as in group II (trabeculectomy) except with no sclerectomy or peripheral iridectomy , the steps included conjunctival peritomy superior-temporally away from the site of the fibrotic bleb at 12 o'clock, placed on the episclera under the conjunctiva and Tenon's capsule for a contact time of 3 minutes, ,triangular scleral flap , scleral dissection forward to the clear cornea to allow exposure of scleral spur then creation of a pilot hole is fashioned using a sapphire blade (Alcon laboratories,USA) then Express shunt 3 mm long device and external diameter 400 microns was implanted followed by closure of scleral flap and conjunctiva. While in group II, Trabeculectomy with Mitomycin-C was done in superior-temporal region away from the fibrotic bleb at 12 o, clock. | Procedure or surgery | group I (Express implant), group II (trabeculectomy) |
Primary outcome
change of intra ocular pressure (IOP)
Time frame: one year follow up
IOP measured with Goldmann applanation tonometry: Complete success in IOP considered as IOP less than 20 mmHg without treatment and a qualified success in IOP considered as IOP less than 20 mmHg with medical treatment and a failure in IOP control considered if IOP more than or equal 20 mmHg after surgery
3 secondary outcomes
Visual acuity changes by Decimal
Time frame: one year follow up
Glaucomatous visual field (VF) changes in median deviation by decibels (dB)
Time frame: one year follow up
Changes in optic Cup-to-Disc ratio by Volk+90 non-contact lens
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 5 Jun 2020.
- Derived from this study: PubMed 36912740Park J, Rittiphairoj T, Wang X, E JY, Bicket AK. Device-modified trabeculectomy for glaucoma. Cochrane Database Syst Rev. 2023 Mar 13;3(3):CD010472. doi: 10.1002/14651858.CD010472.pub3.
- Individual participant dataSharing planned: Undecided
Related trials for Glaucoma
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)
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
Recruiting
Effects of Balance Training in Individuals With Glaucoma
Glaucoma
Not yet recruiting
Glaucoma Drop Aids Part 2
Glaucoma, Intraocular Pressure
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.
Faried Wagdy, Prof. study chair
Gamal Abd El Nasr st. - Shebin ElKoum - Menofia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Express implant device in people with Glaucoma, run by Menoufia 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 2 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 5 Jun 2020. 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?
change of intra ocular pressure (IOP) (time frame: one year follow up). 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 NCT04417920, 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 5 Jun 2020.