High Frequency Deep Sclerotomy (HFDS) ab Interno a Combination Surgical Intervention Using Cataract Surgery to Lower IOP (HFDS_abinterno)

Oertli Instruments

Status: Unknown

Conditions: POAG; Cataract; Glaucoma

Treatments: Procedure: Phacoemulsification with IOL implantation; Procedure: Combined sclerotomy ab interno and phaco

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02312362

HFDS_PS_v9

Details and patient eligibility

About

Objective:

To compare intraocular pressure lowering effect of combined sclerotomy ab interno with phacoemulsification and phacoemulsification alone, in primary or secondary open angle glaucoma patients.

Study design:

Prospective, randomized, case- control interventional surgical trial

Enrollment: 108 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients suffering from primary open-angle glaucoma (POAG) inadequately controlled with maximum tolerated medical therapy and who will be treated with cataract surgery.

Exclusion criteria

• One eyed patients
• Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits
• The presence of extreme narrow angle with complete or partial closure in either eye, except for occludable angles treated with a patent iridectomy
• Any abnormality preventing reliable applanation tonometry, any opacity or patient uncooperativeness that would restrict adequate examination of the ocular fundus or anterior chamber of either eye
• The risk of visual field or visual acuity worsening as a consequence of participation in the trial, in the investigator's opinion
• Any clinically significant, serious, or severe medical or psychiatric condition; any condition that, in the investigator's opinion, would interfere with optimal participation in the study or present a special risk to the patient
• Participation in any other investigational study within 30 days prior to baseline visit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Combined sclerotomy ab interno and phaco

Experimental group

Description:

Combined sclerotomy ab interno and phacoemulsification with IOL implantation

Treatment:

Procedure: Combined sclerotomy ab interno and phaco

Phacoemulsification with IOL implantation

Active Comparator group

Description:

Phacoemulsification with IOL implantation

Treatment:

Procedure: Phacoemulsification with IOL implantation