Glaucoma Following Pediatric Cataract Surgery(GATT in GFCS)NCT07542522
Outcome of Gonioscopy-Assisted Transluminal Trabeculotomy in Pediatric Glaucoma Following Cataract Surgery.
A study testing gonioscopy assissted transluminal trabeculotomy in people with Glaucoma Following Pediatric Cataract Surgery, run by Cairo University at 1 site in Egypt.
Trial summary
This prospective case series evaluated the 12-month outcomes of gonioscopy-assisted transluminal trabeculotomy (GATT) in children with glaucoma following cataract surgery (GFCS). Read more about this study
- Who is it for?
- Ages 6 months to 13 years
- Conditions the study is for
- Glaucoma Following Pediatric Cataract Surgery
- What is being tested?
- gonioscopy assissted transluminal trabeculotomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2024to 1 Oct 2025
- 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 6 months to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- pediatric glaucoma following cataract surgery with clear cornea allowing visualization of the angle
Who cannot join
- opaque corneas, extensive synechial angle closure, eyes in which >180° incision could not be achieved and patients who could not complete a 12-month follow-up period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome of Gonioscopy-Assisted Transluminal Trabeculotomy in Glaucoma Following Pediatric Cataract Surgery. A Prospective Interventional Case Series.
This prospective case series evaluated the 12-month outcomes of gonioscopy-assisted transluminal trabeculotomy (GATT) in children with glaucoma following cataract surgery (GFCS).
Glaucoma following pediatric cataract surgery is a recognized postoperative complication that may require surgical management when medical therapy is insufficient. Gonioscopy-assisted transluminal trabeculotomy (GATT) is a minimally invasive conjunctiva-sparing procedure designed to improve aqueous outflow through circumferential trabeculotomy.
This prospective interventional case series will evaluate outcomes of GATT in eligible pediatric patients with glaucoma following cataract surgery treated at Cairo University Hospitals. Participants will undergo preoperative ophthalmic assessment, standardized surgical intervention, and scheduled postoperative follow-up visits. Outcomes to be assessed include intraocular pressure, use of glaucoma medications, and safety parameters during follow-up.
Read the detailed description
12-month Outcome of Gonioscopy-assisted Transluminal Trabeculotomy in Pediatric Glaucoma Following Cataract Surgery.
Abstract Introduction Glaucoma following cataract surgery (GFCS) represents the most common vision-threatening complication after pediatric lensectomy, frequently necessitating surgical management. While ab-externo circumferential trabeculotomy has yielded promising results in previous studies, gonioscopy-assisted transluminal trabeculotomy (GATT) offers a minimally invasive, conjunctiva-sparing ab-interno approach for circumferential angle incision. This study evaluated the outcome of GATT in children diagnosed with GFCS.
Methods This prospective interventional case series included 30 eyes of 24 pediatric patients (aged 0.5-13 years) diagnosed with GFCS. We excluded eyes with opaque corneas, extensive synechial angle closure, eyes in which >180° incision could not be achieved and patients who could not complete a 12-month follow-up period. The primary outcomes were IOP reduction and changes in number of antiglaucoma medications; secondary outcomes were surgical success and complications. Success was defined as final IOP ≤21 mmHg without further glaucoma intervention and absence of vision-threatening complications.
- Being tested
- gonioscopy assissted transluminal trabeculotomy
- Keywords
- GATT - GFCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gonioscopy assissted transluminal trabeculotomyProcedure or surgery
The operating microscope is tilted 45 degrees,, the head of the bed is elevated, and the head of the patient is tilted to the opposite side. While sitting on the temporal side of the patient a temporal corneal incision is created by a 23 Gauge MVR. An inferior or superior paracentesis is created. The anterior chamber (AC) is filled using cohesive viscoelastic then the angle is visualized by direct gonioscopy using Swan Jacob lens. Nasal goniotomy for 2 clock is performed by using MVR blade to incise the inner wall of Schlemm's canal. Cohesive OVD is used to open the lips of the incision, then 5/0 prolene after being blunted by cautery pen is threaded inside Schlemm's canal guided it inside the canal using 23-gauge vitreoretinal forceps until we retrieve it from the opposite end of the incision. The two ends of the 5/0 prolene suture are pulled to incise the Schlemm's canal and trabecular meshwork over 360°.The AC is washed by BSS followed by injection of air to tamponade any bleeding t
| Study group | Role | What they receive |
|---|---|---|
| Pediatric glaucoma following cataract surgery | Experimental | All enrolled pediatric eyes with glaucoma following cataract surgery underwent gonioscopy-assisted transluminal trabeculotomy (GATT) as the sole intervention. No comparison or control group was included. Receives: Procedure: gonioscopy assissted transluminal trabeculotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP reduction
Change in intraocular pressure (IOP) from baseline to 12 months after gonioscopy-assisted transluminal trabeculotomy (GATT) in pediatric eyes with glaucoma following cataract surgery
Measured: 12 month post operative
Change in Number of Antiglaucoma Medications
Change in the number of antiglaucoma medications used from baseline to 12 months after GATT in pediatric eyes with glaucoma following cataract surgery.
Measured: 12 month postoperatively
Secondary outcomes (1)
surgical success
Success was defined as final IOP ≤21 mmHg without further glaucoma intervention and absence of vision-threatening complications.
Measured: 12 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start20 May 2024
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
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 Glaucoma Following Pediatric Cataract SurgeryStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Not applicable
- Intervention model
- Single group
- Model description
- This was a single-group interventional study in which all enrolled eyes underwent gonioscopy-assisted transluminal trabeculotomy (GATT) without a comparison group.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Elsayed Soliman Ahmed, Cairo University
- Investigators
- Marwa E Soliman, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542522
- Sponsor's protocol ID
- MD-196-2024
- Acronym
- (GATT in GFCS)
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: individual participant data will be available upon reasonable request for research
Publications
Grover DS, Godfrey DG, Smith O, Feuer WJ, Montes de Oca I, Fellman RL. Gonioscopy-assisted transluminal trabeculotomy, ab interno trabeculotomy: technique report and preliminary results. Ophthalmology. 2014 Apr;121(4):855-61. doi: 10.1016/j.ophtha.2013.11.001. Epub 2014 Jan 10.
PubMed 24412282El Sayed YM, Elhusseiny AM, Gawdat GI, Elhilali HM. One-year results of two-site trabeculotomy in paediatric glaucoma following cataract surgery. Eye (Lond). 2021 Jun;35(6):1637-1643. doi: 10.1038/s41433-020-01138-w. Epub 2020 Aug 21.
PubMed 32827001Freedman SF, Beck AD, Nizam A, Vanderveen DK, Plager DA, Morrison DG, Drews-Botsch CD, Lambert SR; Infant Aphakia Treatment Study Group. Glaucoma-Related Adverse Events at 10 Years in the Infant Aphakia Treatment Study: A Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2021 Feb 1;139(2):165-173. doi: 10.1001/jamaophthalmol.2020.5664.
PubMed 33331850
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Gonioscopy-Assisted Transluminal Trabeculotomy in Glaucoma Following Pediatric Cataract Surgery. A Prospective Interventional Case Series.
- ClinicalTrials.gov ID
- NCT07542522
- Acronym / sponsor ID
- (GATT in GFCS) / MD-196-2024
- Keywords
- GATT - GFCS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 21 Apr 2026 (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.
This prospective case series evaluated the 12-month outcomes of gonioscopy-assisted transluminal trabeculotomy (GATT) in children with glaucoma following cataract surgery (GFCS).
Glaucoma following pediatric cataract surgery is a recognized postoperative complication that may require surgical management when medical therapy is insufficient. Gonioscopy-assisted transluminal trabeculotomy (GATT) is a minimally invasive conjunctiva-sparing procedure designed to improve aqueous outflow through circumferential trabeculotomy.
This prospective interventional case series will evaluate outcomes of GATT in eligible pediatric patients with glaucoma following cataract surgery treated at Cairo University Hospitals. Participants will undergo preoperative ophthalmic assessment, standardized surgical intervention, and scheduled postoperative follow-up visits. Outcomes to be assessed include intraocular pressure, use of glaucoma medications, and safety parameters during follow-up.
Detailed description
12-month Outcome of Gonioscopy-assisted Transluminal Trabeculotomy in Pediatric Glaucoma Following Cataract Surgery.
Abstract Introduction Glaucoma following cataract surgery (GFCS) represents the most common vision-threatening complication after pediatric lensectomy, frequently necessitating surgical management. While ab-externo circumferential trabeculotomy has yielded promising results in previous studies, gonioscopy-assisted transluminal trabeculotomy (GATT) offers a minimally invasive, conjunctiva-sparing ab-interno approach for circumferential angle incision. This study evaluated the outcome of GATT in children diagnosed with GFCS.
Methods This prospective interventional case series included 30 eyes of 24 pediatric patients (aged 0.5-13 years) diagnosed with GFCS. We excluded eyes with opaque corneas, extensive synechial angle closure, eyes in which >180° incision could not be achieved and patients who could not complete a 12-month follow-up period. The primary outcomes were IOP reduction and changes in number of antiglaucoma medications; secondary outcomes were surgical success and complications. Success was defined as final IOP ≤21 mmHg without further glaucoma intervention and absence of vision-threatening complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This was a single-group interventional study in which all enrolled eyes underwent gonioscopy-assisted transluminal trabeculotomy (GATT) without a comparison group.
| Arm | Type | Receives |
|---|---|---|
| Pediatric glaucoma following cataract surgery | Experimental | Procedure: gonioscopy assissted transluminal trabeculotomyAll enrolled pediatric eyes with glaucoma following cataract surgery underwent gonioscopy-assisted transluminal trabeculotomy (GATT) as the sole intervention. No comparison or control group was included. |
Who may qualify
- Ages
- 6 months to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- pediatric glaucoma following cataract surgery with clear cornea allowing visualization of the angle
Key exclusion criteria (1 listed)
- opaque corneas, extensive synechial angle closure, eyes in which >180° incision could not be achieved and patients who could not complete a 12-month follow-up period
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 |
|---|---|---|
| gonioscopy assissted transluminal trabeculotomyThe operating microscope is tilted 45 degrees,, the head of the bed is elevated, and the head of the patient is tilted to the opposite side. While sitting on the temporal side of the patient a temporal corneal incision is created by a 23 Gauge MVR. An inferior or superior paracentesis is created. The anterior chamber (AC) is filled using cohesive viscoelastic then the angle is visualized by direct gonioscopy using Swan Jacob lens. Nasal goniotomy for 2 clock is performed by using MVR blade to incise the inner wall of Schlemm's canal. Cohesive OVD is used to open the lips of the incision, then 5/0 prolene after being blunted by cautery pen is threaded inside Schlemm's canal guided it inside the canal using 23-gauge vitreoretinal forceps until we retrieve it from the opposite end of the incision. The two ends of the 5/0 prolene suture are pulled to incise the Schlemm's canal and trabecular meshwork over 360°.The AC is washed by BSS followed by injection of air to tamponade any bleeding t | Procedure or surgery | Pediatric glaucoma following cataract surgery |
Primary outcome
IOP reduction
Time frame: 12 month post operative
Change in intraocular pressure (IOP) from baseline to 12 months after gonioscopy-assisted transluminal trabeculotomy (GATT) in pediatric eyes with glaucoma following cataract surgery
Change in Number of Antiglaucoma Medications
Time frame: 12 month postoperatively
Change in the number of antiglaucoma medications used from baseline to 12 months after GATT in pediatric eyes with glaucoma following cataract surgery.
1 secondary outcome
surgical success
Time frame: 12 month postoperatively
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 21 Apr 2026.
- Results publication: PubMed 24412282Grover DS, Godfrey DG, Smith O, Feuer WJ, Montes de Oca I, Fellman RL. Gonioscopy-assisted transluminal trabeculotomy, ab interno trabeculotomy: technique report and preliminary results. Ophthalmology. 2014 Apr;121(4):855-61. doi: 10.1016/j.ophtha.2013.11.001. Epub 2014 Jan 10.
- Results publication: PubMed 32827001El Sayed YM, Elhusseiny AM, Gawdat GI, Elhilali HM. One-year results of two-site trabeculotomy in paediatric glaucoma following cataract surgery. Eye (Lond). 2021 Jun;35(6):1637-1643. doi: 10.1038/s41433-020-01138-w. Epub 2020 Aug 21.
- Results publication: PubMed 33331850Freedman SF, Beck AD, Nizam A, Vanderveen DK, Plager DA, Morrison DG, Drews-Botsch CD, Lambert SR; Infant Aphakia Treatment Study Group. Glaucoma-Related Adverse Events at 10 Years in the Infant Aphakia Treatment Study: A Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2021 Feb 1;139(2):165-173. doi: 10.1001/jamaophthalmol.2020.5664.
- Individual participant dataSharing planned: Undecided. individual participant data will be available upon reasonable request for research
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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.
Marwa E Soliman principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gonioscopy assissted transluminal trabeculotomy in people with Glaucoma Following Pediatric Cataract Surgery, run by Cairo 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 1 inclusion and 1 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 21 Apr 2026. 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 reduction (time frame: 12 month post operative). 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 NCT07542522, 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 21 Apr 2026.