A Clinical Trial of Phacoemulsification Versus Phacoemulsification & the iStent Implantation in POAG Patients

NCT ID: NCT00847158

Last Updated: 2009-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2008-03-31

Brief Summary

This was a prospective, double-masked, 15-month clinical trial comparing efficacy of phacoemulsification alone to combined phacoemulsification and implantation of the iStent® trabecular micro-bypass stent in patients with primary open-angle glaucoma.

Detailed Description

This was a prospective, randomized open-label study of 36 patients with POAG scheduled to undergo phacoemulsification with intraocular lens implantation ("cataract surgery"). Patients were randomized 2:1 to receive either cataract surgery alone (control group) or cataract surgery and iStent implantation (combined surgery group).

Implantation of the study stent occurred after cataract extraction and IOL insertion using the same small, temporal, clear-corneal incision (approximately 3 mm) used to perform phacoemulsification and IOL placement. The study stent was guided into Schlemm's canal using ab-interno gonioscopy (using a Swan-Jacobs gonioscope). (Figure 1) If no complications occurred during phacoemulsification, acetylcholine was injected in the anterior chamber after the IOL implantation to constrict the pupil. The anterior chamber was then filled with a viscoelastic agent to reform the anterior chamber and provide more clearance in the angle.

The anterior chamber was traversed with the applicator (the implant was on the tip of applicator) and the trabecular meshwork located. The leading edge of the device was gently slid through the trabecular meshwork and into Schlemm's canal at the nasal position (3 to 4 o'clock for the right eye; 9 to 8 o'clock for the left eye) with the tip of the implant directed inferiorly. If difficulty was encountered with the insertion at the primary location, we tried inserting about 0.5 clock hour inferiorly; and continued to move inferiorly as needed for subsequent attempts. Next, the device was released by pushing the button on the applicator, position of the stent was verified and the applicator was withdrawn.

The patients were instructed to discontinue all glaucoma medications after surgery. Standard post cataract extraction antibiotic and anti-inflammatory drug regimen was prescribed. Target pressure for each patient was determined prior to study entry. Following the assigned procedure, any patient with an IOP (as measured between 8 and 10 AM) that was greater than 2 mm Hg over their target was instructed to return twice in the following three days for re-measurement of their IOP. If the patient's IOP was > 2 mm Hg over their target pressure, ocular hypotensive agents were added. The medications were added in a pre-set schedule, with beta-blockers first, angiotensin-converting enzyme (ACE) inhibitors second, and prostaglandins third. If, however, on the third consecutive visit the patient's IOP was within 2 mm Hg of target, patient re-entered the normal visit schedule. Investigators were masked to treatment assignment both when measuring IOP and when determining when or if to add medications.

Conditions

Primary Open Angle Glaucoma and Cataracts

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

phacoemulsification alone

Group Type: ACTIVE_COMPARATOR

phacoemulsification alone

Intervention Type: PROCEDURE

phacoemulsification alone

2

phacoemulsification and implantation of the iStent® trabecular micro-bypass stent

Group Type: ACTIVE_COMPARATOR

iStent Trabecular Micro-Bypass Stent

Intervention Type: DEVICE

phacoemulsification and implantation of the iStent® trabecular micro-bypass stent

Interventions

phacoemulsification alone

phacoemulsification alone

Intervention Type: PROCEDURE

iStent Trabecular Micro-Bypass Stent

phacoemulsification and implantation of the iStent® trabecular micro-bypass stent

Intervention Type: DEVICE

Other Intervention Names

cataract surgery; Phaco; iStent, Trabecular micro-bypass stent, GTS100L, GTS100R

Eligibility Criteria

Inclusion Criteria

• a previous diagnosis of POAG
• an IOP of > 18 mm Hg at three separate visits if on one medication, or subjects on at least two medications with uncontrolled IOP on three separate visits.
• all patients were deemed likely to follow surgeon instructions and were able to give informed consent.

Exclusion Criteria

• any glaucoma diagnosis other than POAG
• the presence of peripheral anterior synechiae (PAS)
• a cloudy cornea likely to inhibit gonioscopic view of the angle
• any previous ocular surgery
• history of trauma or ocular surface disease
• the presence of peripheral anterior synechiae (PAS)
• a cloudy cornea likely to inhibit gonioscopic view of the angle

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

University of Turin, Italy

Principal Investigators

Antonio Fea, MD

Role: PRINCIPAL_INVESTIGATOR

University of Torino

References

Fea AM, Consolandi G, Zola M, Pignata G, Cannizzo P, Lavia C, Rolle T, Grignolo FM. Micro-Bypass Implantation for Primary Open-Angle Glaucoma Combined with Phacoemulsification: 4-Year Follow-Up. J Ophthalmol. 2015;2015:795357. doi: 10.1155/2015/795357. Epub 2015 Oct 26.

Reference Type: DERIVED

PMID: 26587282 (View on PubMed)

Other Identifiers

iStent Washout study

Identifier Type: -

Identifier Source: org_study_id