NCT02945202

Brief Summary

This study investigates the effects of trabeculectomy and combined phacoemulsification plus trabeculectomy on corneal astigmatism.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

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

First Submitted

Initial submission to the registry

October 20, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 26, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

11 months

First QC Date

October 20, 2016

Last Update Submit

October 26, 2016

Conditions

AstigmatismGlaucoma

Outcome Measures

Primary Outcomes (1)

  • Difference in Astigmatism [Diopters (dpt)]

    preoperative astigmatism compared to 6 months postoperatively

Study Arms (1)

All Eyes

OTHER

All eyes undergo the same interventions. These are the following examinations: Biometry, Refraction and Corneal Topography. The examinations take place 6 months after surgery

Device: BiometryDevice: RefractionDevice: Corneal Topography

Interventions

BiometryDEVICE

All patients undergo all three examinations (biometry, refraction and corneal topography) 6 months after surgery

All Eyes
RefractionDEVICE

All patients undergo all three examinations (biometry, refraction and corneal topography) 6 months after surgery

All Eyes
Corneal TopographyDEVICE

All patients undergo all three examinations (biometry, refraction and corneal topography) 6 months after surgery

All Eyes

Eligibility Criteria

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

You may qualify if:

  • Trabeculectomy or Phaco-Trabeculectomy between 01/2017 and 12/2017
  • Age ≥18 years

You may not qualify if:

  • Acute or chronic corneal diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AstigmatismGlaucoma

Interventions

BiometryRefraction, OcularCorneal Topography

Condition Hierarchy (Ancestors)

Refractive ErrorsEye DiseasesOcular Hypertension

Intervention Hierarchy (Ancestors)

Statistics as TopicEpidemiologic MethodsInvestigative TechniquesEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthVision TestsDiagnostic Techniques, OphthalmologicalDiagnostic Techniques and ProceduresDiagnosisOptical PhenomenaPhysical PhenomenaOcular Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2016

First Posted

October 26, 2016

Study Start

January 1, 2017

Primary Completion

December 1, 2017

Study Completion

February 1, 2018

Last Updated

October 27, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share