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OpenTrials
Completed

NCT Number: NCT03162471

How Astigmatism Influences Corneal Biomechanics and Intraocular Pressure

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.

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Key information

Age range

52 year–90 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

non-contact measurement of intraocular pressure

Diagnostic Test

Non-contact measurement of corneal biomechanical properties and intraocular pressure with an Ocular Response Analyzer. Parameters measured: corneal hysteresis (CH), corneal resistance factor (CRF), Goldman-correlated IOP (IOPg), corneal compensated IOP (IOPcc) and waveform score (WS).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Medical University of Lodz

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2016
Study completion
2016
First posted
May 22, 2017
Registry last updated
May 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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