Trial results comparing the Baerveldt 350 and Ahmed ClearPath 250 tube shunts for the treatment of Glaucoma were posted on ClinicalTrials.gov on 2026-04-17, with 80 participants enrolled.
Background
Glaucoma is a group of eye conditions that damage the optic nerve, often caused by abnormally high pressure inside the eye (intraocular pressure or IOP). It is a leading cause of irreversible blindness worldwide. Current treatments aim to lower IOP to prevent further optic nerve damage and vision loss. When eye drops or laser treatments are insufficient, surgical interventions, such as the implantation of tube shunts, become necessary. This study compares two commonly used tube shunts, the Baerveldt 350 and Ahmed ClearPath 250, to assess their respective safety and efficacy in controlling IOP in glaucoma patients.
Trial design
This completed study, designated as Phase NA, enrolled 80 participants to investigate the treatment of Glaucoma. The trial's objective was to compare the safety and efficacy of Baerveldt 350 and Ahmed ClearPath 250 tube shunts in lowering IOP. Participants received either a Baerveldt 350 or an Ahmed ClearPath 250 tube shunt as a surgical intervention.
Key results
The trial reported several key measurements related to Intraocular Pressure (IOP) for both treatment groups:
- Intraocular Pressure (IOP) for Baerveldt 350 group:
- A mean IOP of 22.58 mmHg (Standard Deviation 8.62) was observed.
- A subsequent mean IOP of 15.0 mmHg (Standard Deviation 4.8) was observed.
- A subsequent mean IOP of 11.7 mmHg (Standard Deviation 4.7) was observed.
- A subsequent mean IOP of 11.3 mmHg (Standard Deviation 4.3) was observed.
- A subsequent mean IOP of 10.0 mmHg (Standard Deviation 3.7) was observed.
- A subsequent mean IOP of 10.9 mmHg (Standard Deviation 4.0) was observed.
- Intraocular Pressure (IOP) for Ahmed ClearPath 250 group:
- A mean IOP of 20.95 mmHg (Standard Deviation 7.00) was observed.
- A subsequent mean IOP of 15.1 mmHg (Standard Deviation 4.8) was observed.
- A subsequent mean IOP of 12.1 mmHg (Standard Deviation 4.3) was observed.
- A subsequent mean IOP of 12.2 mmHg (Standard Deviation 5.3) was observed.
- A subsequent mean IOP of 12.0 mmHg (Standard Deviation 4.4) was observed.
- A subsequent mean IOP of 13.6 mmHg (Standard Deviation 3.7) was observed.
What this means
The reported results indicate that both the Baerveldt 350 and Ahmed ClearPath 250 tube shunts effectively lowered intraocular pressure in glaucoma patients from initial higher levels. The Baerveldt 350 group showed a final mean IOP of 10.9 mmHg, while the Ahmed ClearPath 250 group showed a final mean IOP of 13.6 mmHg among the reported measurements. These specific IOP values provide clinicians with comparative data on the performance of these two surgical devices in managing glaucoma, offering insights into their potential roles in patient care.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study titled "Baerveldt 350 vs Ahmed ClearPath 250 for the Treatment of Glaucoma" were posted on 2026-04-17 on clinicaltrials.gov.