NCT02312362

Brief 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

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable

Geographic Reach
4 countries

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 9, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 9, 2014

Status Verified

December 1, 2014

Enrollment Period

2.6 years

First QC Date

December 5, 2014

Last Update Submit

December 5, 2014

Conditions

CataractGlaucomaPOAG

Keywords

HFDSab internoMIGSsurgery

Outcome Measures

Primary Outcomes (3)

  • Intraocular pressure

    Baseline screening till 3 year post-op

  • visual acuity

    Baseline screening till 3 year post-op

  • decrease in anti glaucoma medications

    Baseline screening till 3 year post-op

Study Arms (2)

Combined sclerotomy ab interno and phaco

EXPERIMENTAL

Combined sclerotomy ab interno and phacoemulsification with IOL implantation

Procedure: Combined sclerotomy ab interno and phaco

Phacoemulsification with IOL implantation

ACTIVE COMPARATOR

Phacoemulsification with IOL implantation

Procedure: Phacoemulsification with IOL implantation

Interventions

Combined sclerotomy ab interno and phacoPROCEDURE
Also known as: High Frequency Deep Sclerotomy (=HFDS), HFDS, STT (formerly), abee tip, Cataract surgery combined with HFDS
Combined sclerotomy ab interno and phaco
Phacoemulsification with IOL implantationPROCEDURE
Also known as: Phacoemulsification, Phaco, Cataract Surgery
Phacoemulsification with IOL implantation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Aswān, Egypt

COMPLETED

Unknown Facility

Kiel, Germany

RECRUITING

Unknown Facility

Mumbai, India

RECRUITING

Unknown Facility

Geneva, Switzerland

RECRUITING

Unknown Facility

Reinach, Switzerland

RECRUITING

Related 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.

    PMID: 20520572BACKGROUND

MeSH Terms

Conditions

CataractGlaucoma

Interventions

rhoA GTP-Binding ProteinPhacoemulsificationCataract Extraction

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesOcular Hypertension

Intervention Hierarchy (Ancestors)

rho GTP-Binding ProteinsMonomeric GTP-Binding ProteinsGTP-Binding ProteinsGTP PhosphohydrolasesAcid Anhydride HydrolasesHydrolasesEnzymesEnzymes and CoenzymesCarrier ProteinsProteinsAmino Acids, Peptides, and ProteinsIntracellular Signaling Peptides and ProteinsRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Officials

  • Farhad Hafezi, MD, PhD

    University of Geneva, Switzerland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lothar Knuenz

CONTACT

lothar.knuenz@oertli-instruments.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2014

First Posted

December 9, 2014

Study Start

November 1, 2012

Primary Completion

June 1, 2015

Study Completion

December 1, 2016

Last Updated

December 9, 2014

Record last verified: 2014-12

Locations

DE(1)EG(1)CH(2)IN(1)