How Astigmatism Influences Corneal Biomechanics and Intraocular Pressure

May 19, 2017 updated by: Zofia Pniakowska, Medical University of Lodz

Impact of Preoperative Astigmatism on Corneal Biomechanics and Accurate Intraocular Pressure Measurement After Micro-incision Phacoemulsification

The aim of the study was to identify whether preoperative corneal astigmatism can influence corneal biomechanics and the assessment of intraocular pressure (IOP) following micro-incision phacoemulsification.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

39

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

52 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

39 patients diagnosed with cataracts were enrolled in the study

Description

Inclusion Criteria:

  • diagnosis and qualification for cataract surgery, corneal astigmatism of equal to or less than 2.25 Dcyl

Exclusion Criteria:

  • corneal astigmatism higher than 2.25 Dcyl, history of any other corneal disease (infection, trauma, ulceration, autoimmune inflammation, Fuchs Dystrophy, keratoconus, corneal scars, preoperative insufficiency of corneal endothelium), glaucoma and chronic use of non-glaucoma eye drops, blepharitis, dry eye, use of contact lenses diabetes or a history of corneal refractive surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of corneal compensated IOP (IOPcc)
Time Frame: Parameter measured preoperatively and one day, one week, one month postoperatively
Intraocular pressure and corneal biomechanical properties were measured using an Ocular Response Analyzer.
Parameter measured preoperatively and one day, one week, one month postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of corneal hysteresis (CH)
Time Frame: Parameter measured preoperatively and one day, one week, one month postoperatively
Intraocular pressure and corneal biomechanical properties were measured using an Ocular Response Analyzer.
Parameter measured preoperatively and one day, one week, one month postoperatively
change of corneal resistance factor (CRF)
Time Frame: Parameter measured preoperatively and one day, one week, one month postoperatively
Intraocular pressure and corneal biomechanical properties were measured using an Ocular Response Analyzer.
Parameter measured preoperatively and one day, one week, one month postoperatively
change of Goldman-correlated IOP (IOPg)
Time Frame: Parameter measured preoperatively and one day, one week, one month postoperatively
Intraocular pressure and corneal biomechanical properties were measured using an Ocular Response Analyzer.
Parameter measured preoperatively and one day, one week, one month postoperatively
change of waveform score (WS)
Time Frame: Parameter measured preoperatively and one day, one week, one month postoperatively
Intraocular pressure and corneal biomechanical properties were measured using an Ocular Response Analyzer.
Parameter measured preoperatively and one day, one week, one month postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Lodz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2005

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

May 17, 2017

First Submitted That Met QC Criteria

May 19, 2017

First Posted (Actual)

May 22, 2017

Study Record Updates

Last Update Posted (Actual)

May 22, 2017

Last Update Submitted That Met QC Criteria

May 19, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNN/166/17/KE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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