Refractory Glaucoma
Conditions
Keywords
Ahmed valve, single-plate Molteno implant, refractory glaucoma, surgical treatment
Brief summary
The purpose of this study is to investigate the efficacy and safety of the Ahmed valve implant (AVI) and the Molteno single-plate implant (MSPI) in eyes with refractory glaucoma during a follow-up period of 24 months.
Interventions
DEVICEAhmed valve implant
184 mm2 surface area Ahmed Glaucoma Valve (AGV Model FP7; New World Medical Inc., Rancho Cucamonga, California, USA)
DEVICEMolteno single-plate implant (MSPI)
134 mm2 surface area single-plate Molteno implant (Molteno Ophthalmic Limited, Dunedin, New Zealand)
Sponsors
Vanak Eye Surgery Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* refractory glaucoma, defined as uncontrolled IOP despite maximal anti-glaucoma medication, previously failed nonseton surgical treatment, or a combination thereof.
Exclusion criteria
* age less than 40 years * a visual acuity of no light perception * lens opacity * elevated IOP associated with silicone oil previous glaucoma drainage device implantation in the same eye * previous cyclodestructive treatment * increased risk of endophthalmitis posterior segment disorders * pre-existing ocular comorbidities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intra Ocular pressure (IOP) | Month 24 |
Secondary
| Measure | Time frame |
|---|---|
| Intra Ocular pressure (IOP) | day 1,week 1, and months 1, 3, 6, 9, 12 and 18 |
| Changes in visual acuity | day 1,week 1, and months 1, 3, 6, 9, 12, 18, and 24. |
| Number of anti-glaucoma medications | week 1, and months 1, 3, 6, 9, 12, 18, and 24 |
| Mean deviation of visual field, | week 1, and months 1, 3, 6, 9, 12, 18, and 24 |
| Rate of intra- and postoperative complications | week 1, and months 1, 3, 6, 9, 12, 18, and 24 |
Countries
Iran
Outcome results
None listed