Safety and Efficacy of Canaloplasty and Non-penetrating Deep Sclerectomy With Phacoemulsification to Treat Glaucoma and Cataract

Military Institute od Medicine National Research Institute

Status: Unknown

Conditions: Cataract; Open Angle Glaucoma

Treatments: Procedure: Non-penetrating deep sclerectomy and phacoemulsification; Procedure: Canaloplasty and phacoemulsification

Study type: Interventional

Funder types: Other

Identifiers

NCT01726543

BW1 151/12

BW1151/12 (Other Identifier)

Details and patient eligibility

About

It is a comparative study of Safety and Efficacy of Canaloplasty and Non-penetrating Deep Sclerectomy Combined With Phacoemulsification to Treat Glaucoma and Cataract. It is a Randomised, Prospective Study.

Enrollment: 80 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• co-existing glaucoma and cataract
• glaucoma types ( open angle glaucoma,pseudoexfoliation syndrome, pigmentary glaucoma)
• eye with characteristic glaucoma changes (biomicroscopic,visual field) with IOP >16mmHg on medication or without, or IOP<16mmHg on 2 or more medications.
• uncontrolled IOP
• patients not tolerating antiglaucoma medications,
• patients with poor compliance
• progression in visual field

Exclusion criteria

• previous surgical glaucoma procedure
• previous cataract surgery
• visual function under 0,004
• closed angle glaucoma
• poorly controlled diabetes mellitus
• advanced AMD
• active inflammatory disease
• pregnancy
• mental disease or emotional instability, that could

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Canaloplasty and phacoemulsification

Active Comparator group

Treatment:

Procedure: Canaloplasty and phacoemulsification

Non-penetrating deep sclerectomy and phacoemulsification

Active Comparator group

Treatment:

Procedure: Non-penetrating deep sclerectomy and phacoemulsification