Glaucoma
Conditions
Brief summary
A randomized controlled trial comparing the efficacy and safety of Paul glaucoma implant and Ahmed glaucoma valve in refractory childhood glaucoma patients
Detailed description
A prospective randomized controlled trial was conducted at Al Watany Eye Hospital in Egypt. Patients with refractory primary or secondary childhood glaucoma who glaucoma specialist has decided to perform a tube implant to control their intraocular pressure are randomized to receive either Paul or Ahmed glaucoma drainage devices. Patients will be followed up for at least one year during which the following data are collected. Age, sex, laterality, preoperative and postoperative intraocular pressure and glaucoma medications at 1,3,6, 9, and 12 months visits. Any intraoperative or postoperative complications will be recorded
Interventions
DEVICEGlaucoma Drainage Device
Both the Paul glaucoma implant (PGI) and Ahmed glaucoma valve (AGV) are types of glaucoma drainage devices (GDDs) used to lower intraocular pressure in patients with refractory glaucoma. Devices will be implanted during a surgical procedure and work by diverting excess fluid from the eye to an external drainage tube, allowing the fluid to drain away from the eye and be absorbed into the surrounding tissue. This will help to lower the pressure inside the eye, which is important for preventing vision loss and other complications associated with glaucoma.
Sponsors
Moorfields Eye Hospital Centre Abu Dhabi
Al Watany Eye Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Childhood glaucoma patients (whether primary or secondary) including Juvenile open angle glaucoma if the age at the time of surgery was ≤18 years. * The included patients are those with refractory glaucoma who require a tube to control their intraocular pressure.
Exclusion criteria
* Any patient with incomplete data or has a follow-up less than 1 year will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IOP Reduction | 1 year | More than 20% change from baseline without development of vision threatening complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glaucoma Medication Alterations | 1 year | Assessment of changes in number of medications for IOP reduction after procedure (i.e., did patients have a reduction or gain in use of medications to reduce their IOP after the procedure?) |
| Post-operative complications | 1 year | — |
Countries
Egypt
Contacts
Primary ContactMohamed ElBaharwy
Outcome results
None listed