NCT04335825

Brief Summary

The aim of the study is to examine surgical and refractive outcomes of glaucoma combined surgery in six months period of follow up

Trial Health

100
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Status
completed

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

January 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 6, 2020

Completed
Last Updated

April 6, 2020

Status Verified

April 1, 2020

Enrollment Period

3 years

First QC Date

March 28, 2020

Last Update Submit

April 3, 2020

Conditions

GlaucomaOcular HypertensionFiltering Surgery

Keywords

glaucoma combined surgerypostoperative astigmatismpostsurgery refractive error

Outcome Measures

Primary Outcomes (1)

  • IOP

    the change in the level of intraocular pressure

    baseline and six months after surgery

Secondary Outcomes (2)

  • Best corrected visual acuity (BCVA)

    baseline and six months after surgery

  • astigmatism

    baseline and six months after surgery

Study Arms (2)

phacotrabeculectomy

ACTIVE COMPARATOR

patients undergoing phacotrabeculectomy

Procedure: phacotrabeculectomy

ExPress device implantation

ACTIVE COMPARATOR

patients undergoing ExPress antiglaucoma surgery combined with phacoemulsification

Procedure: ExPress antiglaucoma surgery combined with phacoemulsification

Interventions

phacotrabeculectomyPROCEDURE

combined antiglaucoma procedure: trabeculectomy with phacoemulsification

phacotrabeculectomy
ExPress antiglaucoma surgery combined with phacoemulsificationPROCEDURE

combined antiglaucoma procedure: ExPress device implantation with phacoemulsification

ExPress device implantation

Eligibility Criteria

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

You may qualify if:

  • Glaucoma with coexisting cataract graded Nuclear-Cortical 1 (NC1) and Nuclear-Cortical 2 (NC2), according to the The Lens Opacities Classification System III (LOCS III scale), was an indication for surgery.
  • Patients with primary open-angle glaucoma (POAG), pseudoexfoliation glaucoma (PXG) and pigmentary glaucoma (PG), in which satisfactory intraocular pressure (IOP \>21 mmHg) was not achieved despite maximally-tolerated topical and systemic medication, were qualified for treatment.

You may not qualify if:

  • Lack of consent to participate in the study,
  • History of eye surgery or laser procedures within the eye,
  • Closed or narrow angle glaucoma,
  • Diabetes,
  • Advanced macular degeneration
  • Active inflammatory disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Chan HHL, Kong YXG. Glaucoma surgery and induced astigmatism: a systematic review. Eye Vis (Lond). 2017 Nov 17;4:27. doi: 10.1186/s40662-017-0090-x. eCollection 2017.

    PMID: 29177182RESULT

  • Hong YJ, Choe CM, Lee YG, Chung HS, Kim HK. The effect of mitomycin-C on postoperative corneal astigmatism in trabeculectomy and a triple procedure. Ophthalmic Surg Lasers. 1998 Jun;29(6):484-9.

    PMID: 9640570RESULT

  • Alvani A, Pakravan M, Esfandiari H, Safi S, Yaseri M, Pakravan P. Ocular Biometric Changes after Trabeculectomy. J Ophthalmic Vis Res. 2016 Jul-Sep;11(3):296-303. doi: 10.4103/2008-322X.188399.

    PMID: 27621788RESULT

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Design

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

Study Record Dates

First Submitted

March 28, 2020

First Posted

April 6, 2020

Study Start

January 1, 2016

Primary Completion

January 1, 2019

Study Completion

December 30, 2019

Last Updated

April 6, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share

De-identified data of each participant will be available upon email request for all primary and secondary outcome measures

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available on email request for six months after completing the study
Access Criteria
e mail request, after Data Access Agreement is sign