Primary Congenital GlaucomaNCT07550868
Goniotomy in Primary Congenital Glaucoma
An observational study of Primary Congenital Glaucoma and Goniotomy, run by Sun Yat-sen University at 1 site in China.
Trial summary
Brief Summary This is a multicenter cohort study designed to evaluate and compare the efficacy and safety of different surgical extents of goniotomy (GT) - specifically 120°, 240°, and 360° - in the treatment of Primary Congenital Glaucoma (PCG). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Congenital Glaucoma, Goniotomy
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- May 2026to Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants will be recruited from the outpatient clinics of the glaucoma departments or ophthalmology departments at all participating ophthalmic centers or hospitals. Eligible cases meeting the study criteria will be selected from the medical record systems of these participating centers or hospitals.
Who may be able to join
- Diagnosis of primary congenital glaucoma (PCG).
- Underwent goniotomy (GT) of varying extents and grouped by surgical records (120° or 240°or 360°).
- Either gender; no age limit at surgery.
- Voluntary participation, signed informed consent, and compliance with scheduled follow-up. For legally incompetent patients, participation shall be decided by their guardians, who shall provide written informed consent and agree to follow-up.
- Both eyes are included if data are available for both eyes.
Who cannot join
- Concomitant other ocular diseases: including but not limited to diabetic retinopathy, macular degeneration, optic neuropathy, ocular trauma, strabismus, nystagmus, severe dry eye disease, blepharoptosis, or other anterior segment developmental abnormalities.
- The study eye treated with goniotomy (GT) has a history of prior intraocular surgery or ocular trauma.
- Concomitant history of severe systemic diseases: including but not limited to asthma, congenital heart disease, Kawasaki disease, nephropathy, rheumatic and immunologic disorders, digestive system diseases, and malignant neoplasms.
- Women who are pregnant or lactating, or those with an intended pregnancy in the near future.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Different Extents of Goniotomy in Primary Congenital Glaucoma
Brief Summary This is a multicenter cohort study designed to evaluate and compare the efficacy and safety of different surgical extents of goniotomy (GT) - specifically 120°, 240°, and 360° - in the treatment of Primary Congenital Glaucoma (PCG). The study incorporates both retrospective and prospective patient enrollment.
PCG is a rare, severe, and blinding childhood eye disease for which surgery, particularly angle surgery, is the primary treatment. Goniotomy, a minimally invasive glaucoma surgery (MIGS), is increasingly used. However, the optimal extent of the angle incision remains uncertain, with limited and conflicting evidence comparing different ranges.
Read more
The study plans to enroll a total of 120 PCG patients, dividing them into three groups based on the surgical extent received (120°, 240°, or 360°). Patients will be recruited from participating ophthalmic centers across China. The study does not involve interventional assignment; grouping is based on the actual procedure performed as part of standard care.
The primary outcome measure is the qualified surgical success rate post-operatively, defined as intraocular pressure (IOP) ≤21 mmHg (with or without medication), without vision-threatening complications or the need for further glaucoma surgery. IOP will be measured by Goldmann or iCare tonometry. Secondary outcomes include various safety indicators such as intraoperative and postoperative complications, the number of intraocular pressure-lowering medications required, visual acuity, and the need for further surgery.
The study aims to generate comparative evidence to inform clinical decision-making, potentially contributing to optimized surgical guidelines for PCG treatment.
- Conditions
- Primary Congenital Glaucoma, Goniotomy
- Keywords
- Primary congenital glaucoma, goniotomy, Surgery extents
- Medical subject headings
- Hydrophthalmos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 120° goniotomy | By reviewing the surgery record: For 120°GT, in the case of the nasal quadrant, a clear corneal incision, typically 2.2-3.0 mm wide, was made in the temporal quadrant before the injection of ophthalmic viscoelastic devices into the anterior chamber. Subsequently, the patient's head was rotated 35-40 degrees away from the surgeon, and the surgical microscope was tilted 30-40 degrees downward toward the surgeon to enable maximal visualization of the nasal angle. Then, a viscoelastic was applied to the corneal surface, and the surgical goniolens was gently positioned on the cornea and adjusted to observe the nasal angle. A microhook was inserted into the anterior chamber through a corneal incision. The tip of a microhook was then inserted into the Schlemm's canal and moved to incise its inner wall and trabecular meshwork with 120°GT. After aspiration of the ophthalmic viscoelastic devices, the corneal incision was closed. | |
| 240-degree goniotomy | By reviewing the surgery record: For 240°GT, two corneal incisions were made, for example, in the superonasal and superotemporal quadrants or in the temporal and superonasal quadrants. Curved hooks, such as TMH, LAN, were specifically used for the incision in the superonasal position. | |
| 360-degree goniotomy | By reviewing the surgery record: For 360°GT, a corneal incision was made in temporal quadrant firstly. Viscoelastics were then injected into the anterior chamber to deepen it. A 23-gauge tangential paracentesis was performed in either the superonasal or inferonasal quadrant to allow microcatheter entry. A microcatheter was then inserted into the anterior chamber. Under direct visualization with a surgical goniolens, a 1-2 mm goniotomy was performed at the nasal angle using a microblade. Microsurgical forceps were then used to grasp the microcatheter within the anterior chamber and guide its distal tip into the SC at the goniotomy incision. The microsurgical forceps were used to advance the catheter through the canal circumferentially. Once the distal tip was retrieved after the catheter had passed 360 degrees, it was externalized through the temporal corneal incision. Next, traction was applied to the proximal aspect of the catheter and complete the surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualified surgery success
The porportion of participants who achieve Intraocular pressure (IOP) ≤ 21 mmHg regardless of topical hypotensive medications, no vision-threatening complications, and no reoperation. The IOP will be measured using Goldmann applanation tonometry or iCare tonometer.
Measured: Postoperatively Day1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36.
Complete surgery success
The porportion of participants who achieve Intraocular pressure (IOP) ≤ 21 mmHg without any topical hypotensive medications, no vision-threatening complications, and no reoperation. The IOP will be measured using Goldmann applanation tonometry or iCare tonometer.
Measured: Postoperatively Day1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36.
Secondary outcomes (3)
Topical hypotensive medications
Number of intraocular pressure-lowering medications required postoperatively: the number and types of medications in use at each follow-up visit. The information will be documented per visit from the electric medical system.
Measured: Postoperatively Day1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36.
Surgery complications
Intraoperative and postoperative complications (including shallow anterior chamber, hyphema, persistent hypotony, transient intraocular pressure spike, etc.); other unspecified complications will be also documented per visit.
Measured: Postoperatively Day1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36.
Reoperation
Incidence of additional anti-glaucoma surgery after the initial procedure.
Measured: Postoperatively Day1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Primary Congenital GlaucomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiulan Zhang, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550868
- Sponsor's protocol ID
- 2026KYPJ002
- Status last verified
- Apr 2026
- First submitted
- 12 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hu M, Qiao CY, Wang NL. [Research progress in the diagnosis and treatment of childhood glaucoma]. Zhonghua Yan Ke Za Zhi. 2024 May 11;60(5):458-466. doi: 10.3760/cma.j.cn112142-20231202-00266. Chinese.
PubMed 38706086Malek I, Sayadi J, Choura R, et al. Outcomes of trabeculotomy for primary congenital glaucoma in a Tunisian population. 2023.
Al-Hazmi A, Awad A, Zwaan J, Al-Mesfer SA, Al-Jadaan I, Al-Mohammed A. Correlation between surgical success rate and severity of congenital glaucoma. Br J Ophthalmol. 2005 Apr;89(4):449-53. doi: 10.1136/bjo.2004.047761.
PubMed 15774922Elhilali HM, El Sayed YM, Elhusseiny AM, Gawdat GI. Kahook Dual Blade Ab-interno Trabeculectomy Compared With Conventional Goniotomy in the Treatment of Primary Congenital Glaucoma: 1-Year Results. J Glaucoma. 2021 Jun 1;30(6):526-531. doi: 10.1097/IJG.0000000000001780.
PubMed 33394855Mendicino ME, Lynch MG, Drack A, Beck AD, Harbin T, Pollard Z, Vela MA, Lynn MJ. Long-term surgical and visual outcomes in primary congenital glaucoma: 360 degrees trabeculotomy versus goniotomy. J AAPOS. 2000 Aug;4(4):205-10. doi: 10.1067/mpa.2000.106201.
PubMed 10951295Elwehidy AS, Bayoumi NHL, Abd Elfattah D, Hagras SM. Surgical Outcomes of Visco-Circumferential-Suture-Trabeculotomy Versus Rigid Probe Trabeculotomy in Primary Congenital Glaucoma: A 3-Year Randomized Controlled Study. J Glaucoma. 2022 Jan 1;31(1):48-53. doi: 10.1097/IJG.0000000000001944.
PubMed 34628421M Elwan SA, A Abdallah RM, Abdelhalim AS. Microcatheter-assisted circumferential trabeculotomy in primary congenital glaucoma. Saudi J Ophthalmol. 2022 Feb 18;35(2):117-121. doi: 10.4103/1319-4534.337864. eCollection 2021 Apr-Jun.
PubMed 35391820Neustein RF, Beck AD. Circumferential Trabeculotomy Versus Conventional Angle Surgery: Comparing Long-term Surgical Success and Clinical Outcomes in Children With Primary Congenital Glaucoma. Am J Ophthalmol. 2017 Nov;183:17-24. doi: 10.1016/j.ajo.2017.08.008. Epub 2017 Aug 30.
PubMed 28860043Tonset TS, Jakobsen JE, Tveit JH, Jorstad AL, Brevik TB, Sten LB, Drolsum L. Circumferential (360 degrees ) trabeculotomy in primary congenital glaucoma: 19-245 months of follow-up. Acta Ophthalmol. 2021 Dec;99(8):e1449-e1457. doi: 10.1111/aos.14846. Epub 2021 Mar 19.
PubMed 33742566Wagdy FM. Ab externo 240-degree trabeculotomy versus trabeculotomy-trabeculectomy in primary congenital glaucoma. Int Ophthalmol. 2020 Oct;40(10):2699-2706. doi: 10.1007/s10792-020-01453-x. Epub 2020 Jun 1.
PubMed 32488593El Sayed YM, Gawdat GI. Microcatheter-assisted Trabeculotomy Versus 2-site Trabeculotomy With the Rigid Probe Trabeculotome in Primary Congenital Glaucoma. J Glaucoma. 2018 Apr;27(4):371-376. doi: 10.1097/IJG.0000000000000892.
PubMed 29394197Elwehidy AS, Hagras SM, Bayoumi N, AbdelGhafar AE, Badawi AE. Five-year results of viscotrabeculotomy versus conventional trabeculotomy in primary congenital glaucoma: A randomized controlled study. Eur J Ophthalmol. 2021 Mar;31(2):786-795. doi: 10.1177/1120672120922453. Epub 2020 May 26.
PubMed 32450720Kessel L, Pedersen KB, Siersma V, Kappelgaard P, Bach-Holm D. Long-term success after trabeculotomy in primary congenital glaucoma - a study with up to 35 years follow-up. Acta Ophthalmol. 2021 Jun;99(4):362-368. doi: 10.1111/aos.14619. Epub 2020 Sep 10.
PubMed 32914564Yalvac IS, Satana B, Suveren A, Eksioglu U, Duman S. Success of trabeculotomy in patients with congenital glaucoma operated on within 3 months of birth. Eye (Lond). 2007 Apr;21(4):459-64. doi: 10.1038/sj.eye.6702223. Epub 2006 Jan 6.
PubMed 16397613Huang JL, Huang JJ, Zhong YM, Guo XX, Chen XX, Xu XY, Liu X. Surgical Outcomes of Trabeculotomy in Newborns with Primary Congenital Glaucoma. Chin Med J (Engl). 2016 Sep 20;129(18):2178-83. doi: 10.4103/0366-6999.189925.
PubMed 27625089
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Different Extents of Goniotomy in Primary Congenital Glaucoma
- ClinicalTrials.gov ID
- NCT07550868
- Acronym / sponsor ID
- 2026KYPJ002
- Conditions
- Primary Congenital Glaucoma, Goniotomy
- Keywords
- Primary congenital glaucoma, goniotomy, Surgery extents
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 24 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.
Brief Summary This is a multicenter cohort study designed to evaluate and compare the efficacy and safety of different surgical extents of goniotomy (GT) - specifically 120°, 240°, and 360° - in the treatment of Primary Congenital Glaucoma (PCG). The study incorporates both retrospective and prospective patient enrollment.
PCG is a rare, severe, and blinding childhood eye disease for which surgery, particularly angle surgery, is the primary treatment. Goniotomy, a minimally invasive glaucoma surgery (MIGS), is increasingly used. However, the optimal extent of the angle incision remains uncertain, with limited and conflicting evidence comparing different ranges.
The study plans to enroll a total of 120 PCG patients, dividing them into three groups based on the surgical extent received (120°, 240°, or 360°). Patients will be recruited from participating ophthalmic centers across China. The study does not involve interventional assignment; grouping is based on the actual procedure performed as part of standard care.
The primary outcome measure is the qualified surgical success rate post-operatively, defined as intraocular pressure (IOP) ≤21 mmHg (with or without medication), without vision-threatening complications or the need for further glaucoma surgery. IOP will be measured by Goldmann or iCare tonometry. Secondary outcomes include various safety indicators such as intraoperative and postoperative complications, the number of intraocular pressure-lowering medications required, visual acuity, and the need for further surgery.
The study aims to generate comparative evidence to inform clinical decision-making, potentially contributing to optimized surgical guidelines for PCG treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 120° goniotomy | – | –By reviewing the surgery record: For 120°GT, in the case of the nasal quadrant, a clear corneal incision, typically 2.2-3.0 mm wide, was made in the temporal quadrant before the injection of ophthalmic viscoelastic devices into the anterior chamber. Subsequently, the patient's head was rotated 35-40 degrees away from the surgeon, and the surgical microscope was tilted 30-40 degrees downward toward the surgeon to enable maximal visualization of the nasal angle. Then, a viscoelastic was applied to the corneal surface, and the surgical goniolens was gently positioned on the cornea and adjusted to observe the nasal angle. A microhook was inserted into the anterior chamber through a corneal incision. The tip of a microhook was then inserted into the Schlemm's canal and moved to incise its inner wall and trabecular meshwork with 120°GT. After aspiration of the ophthalmic viscoelastic devices, the corneal incision was closed. |
| 240-degree goniotomy | – | –By reviewing the surgery record: For 240°GT, two corneal incisions were made, for example, in the superonasal and superotemporal quadrants or in the temporal and superonasal quadrants. Curved hooks, such as TMH, LAN, were specifically used for the incision in the superonasal position. |
| 360-degree goniotomy | – | –By reviewing the surgery record: For 360°GT, a corneal incision was made in temporal quadrant firstly. Viscoelastics were then injected into the anterior chamber to deepen it. A 23-gauge tangential paracentesis was performed in either the superonasal or inferonasal quadrant to allow microcatheter entry. A microcatheter was then inserted into the anterior chamber. Under direct visualization with a surgical goniolens, a 1-2 mm goniotomy was performed at the nasal angle using a microblade. Microsurgical forceps were then used to grasp the microcatheter within the anterior chamber and guide its distal tip into the SC at the goniotomy incision. The microsurgical forceps were used to advance the catheter through the canal circumferentially. Once the distal tip was retrieved after the catheter had passed 360 degrees, it was externalized through the temporal corneal incision. Next, traction was applied to the proximal aspect of the catheter and complete the surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will be recruited from the outpatient clinics of the glaucoma departments or ophthalmology departments at all participating ophthalmic centers or hospitals. Eligible cases meeting the study criteria will be selected from the medical record systems of these participating centers or hospitals.
Key inclusion criteria (5 listed)
- Diagnosis of primary congenital glaucoma (PCG).
- Underwent goniotomy (GT) of varying extents and grouped by surgical records (120° or 240°or 360°).
- Either gender; no age limit at surgery.
- Voluntary participation, signed informed consent, and compliance with scheduled follow-up. For legally incompetent patients, participation shall be decided by their guardians, who shall provide written informed consent and agree to follow-up.
- Both eyes are included if data are available for both eyes.
Key exclusion criteria (4 listed)
- Concomitant other ocular diseases: including but not limited to diabetic retinopathy, macular degeneration, optic neuropathy, ocular trauma, strabismus, nystagmus, severe dry eye disease, blepharoptosis, or other anterior segment developmental abnormalities.
- The study eye treated with goniotomy (GT) has a history of prior intraocular surgery or ocular trauma.
- Concomitant history of severe systemic diseases: including but not limited to asthma, congenital heart disease, Kawasaki disease, nephropathy, rheumatic and immunologic disorders, digestive system diseases, and malignant neoplasms.
- Women who are pregnant or lactating, or those with an intended pregnancy in the near future.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Qualified surgery success
Time frame: Postoperatively Day1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36.
The porportion of participants who achieve Intraocular pressure (IOP) ≤ 21 mmHg regardless of topical hypotensive medications, no vision-threatening complications, and no reoperation. The IOP will be measured using Goldmann applanation tonometry or iCare tonometer.
Complete surgery success
Time frame: Postoperatively Day1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36.
The porportion of participants who achieve Intraocular pressure (IOP) ≤ 21 mmHg without any topical hypotensive medications, no vision-threatening complications, and no reoperation. The IOP will be measured using Goldmann applanation tonometry or iCare tonometer.
3 secondary outcomes
Topical hypotensive medications
Time frame: Postoperatively Day1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36.
Surgery complications
Time frame: Postoperatively Day1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36.
Reoperation
Time frame: Postoperatively Day1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Background: PubMed 38706086Hu M, Qiao CY, Wang NL. [Research progress in the diagnosis and treatment of childhood glaucoma]. Zhonghua Yan Ke Za Zhi. 2024 May 11;60(5):458-466. doi: 10.3760/cma.j.cn112142-20231202-00266. Chinese.
- BackgroundMalek I, Sayadi J, Choura R, et al. Outcomes of trabeculotomy for primary congenital glaucoma in a Tunisian population. 2023.
- Background: PubMed 15774922Al-Hazmi A, Awad A, Zwaan J, Al-Mesfer SA, Al-Jadaan I, Al-Mohammed A. Correlation between surgical success rate and severity of congenital glaucoma. Br J Ophthalmol. 2005 Apr;89(4):449-53. doi: 10.1136/bjo.2004.047761.
- Background: PubMed 33394855Elhilali HM, El Sayed YM, Elhusseiny AM, Gawdat GI. Kahook Dual Blade Ab-interno Trabeculectomy Compared With Conventional Goniotomy in the Treatment of Primary Congenital Glaucoma: 1-Year Results. J Glaucoma. 2021 Jun 1;30(6):526-531. doi: 10.1097/IJG.0000000000001780.
- Background: PubMed 10951295Mendicino ME, Lynch MG, Drack A, Beck AD, Harbin T, Pollard Z, Vela MA, Lynn MJ. Long-term surgical and visual outcomes in primary congenital glaucoma: 360 degrees trabeculotomy versus goniotomy. J AAPOS. 2000 Aug;4(4):205-10. doi: 10.1067/mpa.2000.106201.
- Background: PubMed 34628421Elwehidy AS, Bayoumi NHL, Abd Elfattah D, Hagras SM. Surgical Outcomes of Visco-Circumferential-Suture-Trabeculotomy Versus Rigid Probe Trabeculotomy in Primary Congenital Glaucoma: A 3-Year Randomized Controlled Study. J Glaucoma. 2022 Jan 1;31(1):48-53. doi: 10.1097/IJG.0000000000001944.
- Background: PubMed 35391820M Elwan SA, A Abdallah RM, Abdelhalim AS. Microcatheter-assisted circumferential trabeculotomy in primary congenital glaucoma. Saudi J Ophthalmol. 2022 Feb 18;35(2):117-121. doi: 10.4103/1319-4534.337864. eCollection 2021 Apr-Jun.
- Background: PubMed 28860043Neustein RF, Beck AD. Circumferential Trabeculotomy Versus Conventional Angle Surgery: Comparing Long-term Surgical Success and Clinical Outcomes in Children With Primary Congenital Glaucoma. Am J Ophthalmol. 2017 Nov;183:17-24. doi: 10.1016/j.ajo.2017.08.008. Epub 2017 Aug 30.
- Background: PubMed 33742566Tonset TS, Jakobsen JE, Tveit JH, Jorstad AL, Brevik TB, Sten LB, Drolsum L. Circumferential (360 degrees ) trabeculotomy in primary congenital glaucoma: 19-245 months of follow-up. Acta Ophthalmol. 2021 Dec;99(8):e1449-e1457. doi: 10.1111/aos.14846. Epub 2021 Mar 19.
- Background: PubMed 32488593Wagdy FM. Ab externo 240-degree trabeculotomy versus trabeculotomy-trabeculectomy in primary congenital glaucoma. Int Ophthalmol. 2020 Oct;40(10):2699-2706. doi: 10.1007/s10792-020-01453-x. Epub 2020 Jun 1.
- Background: PubMed 29394197El Sayed YM, Gawdat GI. Microcatheter-assisted Trabeculotomy Versus 2-site Trabeculotomy With the Rigid Probe Trabeculotome in Primary Congenital Glaucoma. J Glaucoma. 2018 Apr;27(4):371-376. doi: 10.1097/IJG.0000000000000892.
- Background: PubMed 32450720Elwehidy AS, Hagras SM, Bayoumi N, AbdelGhafar AE, Badawi AE. Five-year results of viscotrabeculotomy versus conventional trabeculotomy in primary congenital glaucoma: A randomized controlled study. Eur J Ophthalmol. 2021 Mar;31(2):786-795. doi: 10.1177/1120672120922453. Epub 2020 May 26.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Congenital Glaucoma and Goniotomy, run by Sun Yat-sen University at 1 site in China.
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 5 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: opening soon, as of the sponsor's last update on 24 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bin Xie, Medical Doctor (+86 17302024374, xiebdoct@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualified surgery success (time frame: Postoperatively Day1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36.). 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 NCT07550868, which also lists 34 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 24 Apr 2026; AzTrials last refreshed its copy on 29 Oct 2026.