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How Astigmatism Influences Corneal Biomechanics and Intraocular Pressure

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ClinicalTrials.gov Identifier: NCT03162471
Recruitment Status : Completed
First Posted : May 22, 2017
Last Update Posted : May 22, 2017
Sponsor:
Information provided by (Responsible Party):
Zofia Pniakowska, Medical Universtity of Lodz

Brief Summary:
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.

Condition or disease Intervention/treatment
Corneal Astigmatism Intraocular Pressure Cataract Senile Diagnostic Test: non-contact measurement of intraocular pressure

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Study Type : Observational
Actual Enrollment : 39 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Impact of Preoperative Astigmatism on Corneal Biomechanics and Accurate Intraocular Pressure Measurement After Micro-incision Phacoemulsification
Actual Study Start Date : May 1, 2005
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : December 1, 2016

Intervention Details:
  • Diagnostic Test: non-contact measurement of intraocular pressure
    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 Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   52 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
39 patients diagnosed with cataracts were enrolled in the study
Criteria

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

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Responsible Party: Zofia Pniakowska, M.D., Medical Universtity of Lodz
ClinicalTrials.gov Identifier: NCT03162471     History of Changes
Other Study ID Numbers: RNN/166/17/KE
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: May 22, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zofia Pniakowska, Medical Universtity of Lodz:
Corneal astigmatism
Cataract surgery
Corneal hysteresis
Corneal resistance factor
Intraocular pressure

Additional relevant MeSH terms:
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Cataract
Astigmatism
Lens Diseases
Eye Diseases
Refractive Errors