Phacoemulsification Versus Phacoemulsification With Micro-bypass Stent

NCT03647033 | Completed Results DMC FDA Device

• 1 other identifier: 2015/00644
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Assessing the safety and efficacy of a micro-bypass stent in combination with cataract surgery in subjects with primary angle closure. Subjects are randomized into two arms: phacoemulsification cataract surgery alone versus phacoemulsification cataract surgery combined with the micro-bypass stent implantation. Post surgery intraocular eye pressure will be recorded to assess the efficacy of both arms.

Conditions

Primary Angle-Closure Glaucoma; Primary Angle Closure Without Glaucoma Damage

Keywords

istent; primary angle closure

Outcome Measures

Primary Outcomes (1)

• Change in Intraocular Pressure Between Baseline and 1 Year

  change in mean unmedicated intraocular pressure between baseline and 1 year

  1 year

Secondary Outcomes (1)

• Change in Glaucoma Medications

  1 year

Study Arms (2)

phacoemulsification alone

NO INTERVENTION

routine phacoemulsification cataract surgery with intraocular lens implantation

phacoemulsification and iStent

EXPERIMENTAL

phacoemulsification cataract surgery with intraocular lens implantation combined with iStent implantation

Device: iStent implantation

Interventions

iStent implantation DEVICE

The iStent is a FDA and Health Sciences Authority (HSA) approved micro-bypass stent device that bypasses the trabecular meshwork (filtration membrane of the aqueous fluid exit pathway) and reroutes aqueous from the anterior chamber directly into canal of Schlemm and out of the eye. It lowers the intraocular pressure (IOP) by increasing the outflow of fluid from the eye from the micro-bypass. In angle closure, the lens has to be removed to create enough space for the iStent to be inserted.

phacoemulsification and iStent

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• able to provide informed consent
• Previous diagnosis of Primary Angle Closure or Primary Angle Closure Glaucoma
• Intraocular Pressure above 21mmHg at 3 separate visits
• On 1 or more hypotensive medications
• Pre-operative visual acuity of no better than 6/12

You may not qualify if:

• Other glaucoma diagnosis: Primary Open Angle Glaucoma, secondary glaucoma
• Peripheral Anterior Synechiae in the nasal and inferior quadrant
• Cloudy cornea affecting view for iStent implantation
• Previous glaucoma surgery
• History of Ocular trauma
• Ocular surface disease
• Pre-proliferative or proliferative diabetic retinopathy
• Age related macular degeneration with macular scar or macular atrophy

Sponsors & Collaborators

• Khoo Teck Puat Hospital: lead

Study Sites (1)

Khoo Teck Puat Hospital

Singapore, 768828, Singapore

Location

Related Publications (4)

• Craven ER, Katz LJ, Wells JM, Giamporcaro JE; iStent Study Group. Cataract surgery with trabecular micro-bypass stent implantation in patients with mild-to-moderate open-angle glaucoma and cataract: two-year follow-up. J Cataract Refract Surg. 2012 Aug;38(8):1339-45. doi: 10.1016/j.jcrs.2012.03.025.

  PMID: 22814041 BACKGROUND

• Fea AM. Phacoemulsification versus phacoemulsification with micro-bypass stent implantation in primary open-angle glaucoma: randomized double-masked clinical trial. J Cataract Refract Surg. 2010 Mar;36(3):407-12. doi: 10.1016/j.jcrs.2009.10.031.

  PMID: 20202537 BACKGROUND

• Malvankar-Mehta MS, Iordanous Y, Chen YN, Wang WW, Patel SS, Costella J, Hutnik CM. iStent with Phacoemulsification versus Phacoemulsification Alone for Patients with Glaucoma and Cataract: A Meta-Analysis. PLoS One. 2015 Jul 6;10(7):e0131770. doi: 10.1371/journal.pone.0131770. eCollection 2015.

  PMID: 26147908 BACKGROUND

• Samuelson TW, Katz LJ, Wells JM, Duh YJ, Giamporcaro JE; US iStent Study Group. Randomized evaluation of the trabecular micro-bypass stent with phacoemulsification in patients with glaucoma and cataract. Ophthalmology. 2011 Mar;118(3):459-67. doi: 10.1016/j.ophtha.2010.07.007. Epub 2010 Sep 15.

  PMID: 20828829 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Angle-Closure

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Results Point of Contact

• Title: Dr. David Chen
• Organization: National University Hospital

david_chen@nuhs.edu.sg

+6594550281

Study Officials

• Philemon Huang, MMed, FAMS

  National Healthcare Group, Singapore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Shuffled envelope system. Patient will be blinded to the procedure. The intraocular pressure (IOP) measure and reader will be blinded to the procedure. There will be no planned breaking of randomization. Unplanned breaking will happen if any envelopes are damaged or lost. Unmasking will take place after 1 year post operation by the study team to inform the patient of the procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single centre, randomised prospective trial, the patient and the intraocular pressure (IOP)checking staff will be blinded. Randomised by random envelope shuffle technique. 1:1 ratio allocation 2 arms: phacoemulsification alone and phacoemulsification and iStent. 16 patients in each arm, 32 patients in total. The post-operative management is the same for both arms After operation the patient will be followed up at day 1, week 1, week 2, months 1, 3, 6 and 12. At each visit the patient will have the following tests: Tonometry (IOP check) - Not to be taken by the operating surgeon, to be taken by 2 people, one IOP checker and one reader.

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 27, 2018
• Study Start: October 14, 2015
• Primary Completion: August 12, 2016
• Study Completion: August 12, 2017
• Last Updated: October 31, 2018
• Results First Posted: October 2, 2018

Record last verified: 2018-09

Locations

SG (1)