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NCT03162471 Clinical Trial

How Astigmatism Influences Corneal Biomechanics and Intraocular Pressure

Intraocular Pressure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03162471
Other study ID # RNN/166/17/KE
Secondary ID
Status Completed
Phase N/A
First received May 17, 2017
Last updated May 19, 2017
Start date May 1, 2005
Est. completion date December 1, 2016

Study information
Verified date May 2017
Source Medical Universtity of Lodz
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 39
Est. completion date December 1, 2016
Est. primary completion date December 1, 2016
Accepts healthy volunteers No
Gender All
Age group 52 Years to 90 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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).

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Medical Universtity of Lodz

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