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

Cataract Clinical Trial

— HFDS_abinterno  

Official title:

HFDS ab Interno - to Compare Intraocular Pressure (IOP) Lowering Effect of Combined High Frequency Deep Sclerotomy ab Interno (HFDS ab Interno) With Phacoemulsification and Phacoemulsification Alone, in Primary Open Angle Glaucoma Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02312362
• Other study ID #: HFDS_PS_v9
• Status: Recruiting
• Phase: N/A
• First received: December 5, 2014
• Last updated: December 5, 2014
• Start date: November 2012
• Est. completion date: December 2016

Study information

• Verified date: December 2014
• Source: Oertli Instrumente AG
• Contact: Lothar Knuenz
• Email: lothar.knuenz[@]oertli-instruments.com
• Is FDA regulated: No
• Health authority: Switzerland: HUG CRC - Centre de recherche clinique
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: December 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Glaucoma
• POAG

Intervention

Procedure:
• Combined sclerotomy ab interno and phaco

• Phacoemulsification with IOL implantation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Oertli Instrumente AG	University of Geneva, Switzerland

Countries where clinical trial is conducted

Egypt,  Germany,  India,  Switzerland, 

References & Publications (1)

Pajic B, Pajic-Eggspuehler B, Haefliger I. New minimally invasive, deep sclerotomy ab interno surgical procedure for glaucoma, six years of follow-up. J Glaucoma. 2011 Feb;20(2):109-14. doi: 10.1097/IJG.0b013e3181dddf31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure		Baseline screening till 3 year post-op	Yes
Primary	visual acuity		Baseline screening till 3 year post-op	No
Primary	decrease in anti glaucoma medications		Baseline screening till 3 year post-op	No