Intraocular Pressure Variation by Pneumatic Tonometer Before and After Phacoemulsification (IPOFACO)

January 6, 2017 updated by: Rodrigo Egidio da Silva, VER Excelência em Oftalmologia
The objective of this study is to evaluate the IOP variation before and 30 days after performing phacoemulsification through pneumatic tonometry, in addition to evaluating the factors possibly related to this variation.

Study Overview

Status

Completed

Conditions

Detailed Description

Cataracts represent the major cause of treatable blindness in developing countries. According to data , there are 45 million blind people in the world, of which 40% is due to cataract etiology. In Brazil, there are about 350,000 individuals blinded by cataracts.

One of the consequences observed after the cataract surgery is the variation of intraocular pressure (IOP). IOP is directly related to the volume of aqueous humor in the anterior chamber. Reports of oscillations after a cataract surgery range from +1.3 to -2.5 mmHg. The duration of this oscillation varies according to the literature studied. Some studies show that the oscillation seen in the first postoperative year was maintained for the 10-year period and was similar in patients of all ages. However, other authors have identified a non-permanent oscillation, which makes this topic controversial in ophthalmology.

There are a number of factors related to the degree of IOP reduction after a cataract surgery. Studies have shown that the preoperative IOP value, the depth of the anterior chamber, the volume of irrigation used during surgery and the age of the patients may interfere with the IOP variation in the postoperative period.

However, the gold standard tonometer for IOP measurement is Goldmann's. This measurement is closely related to important characteristics of the cornea, such as its thickness and curvature, and may underestimate or overestimate IOP values.

Another way to measure IOP is through a non-contact tonometer, blow or pneumatic. The blow tonometer has a pneumatic system that produces a jet of air, which leads to flattening of the cornea and on the surface of which a beam of parallel light rays is projected, in which only the reflected parallel and coaxial rays are picked up by the receiver of the device, obtaining a maximum peak of light reception when the cornea is flattened. Its main advantage is in its use in screening programs, the need for the use of eye drops and the lowest rates of contamination. The blow tonometer, as well as the flattening tonometer, is influenced by corneal factors, such as curvature and thickness, presenting the same parameters of under and overestimation of IOP.

The objective of this study is to evaluate the IOP variation before and 30 days after performing phacoemulsification through pneumatic tonometry, in addition to evaluating the factors possibly related to this variation.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • GO
      • Goiania, GO, Brazil, 74180-010
        • Rodrigo Egidio da Silva

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

People with cataract and with good systemic health

Description

Inclusion Criteria:

  • older than 18 years
  • deep anterior chamber visualized by the slit lamp with open angle estimation using the Van Herick technique
  • IOP lower than 21 mmHg
  • without surgical intercurrences, submitted to phacoemulsification

Exclusion Criteria:

  • younger than 18 years
  • shallow anterior chamber visualized by slit lamp with estimation of narrow angle
  • preoperative surgical complications
  • IOP greater than 21 mmHg
  • contact lens wearers
  • eye surgeries and/or ocular diseases and/or systemic disorders.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intraocular Pressure Variation by Pneumatic Tonometer Before and After Phacoemulsification
Time Frame: Six months
Six months

Collaborators and Investigators

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

Sponsor

VER Excelência em Oftalmologia

Collaborators

Francisco Welington Rodrigues

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

January 6, 2017

First Submitted That Met QC Criteria

January 6, 2017

First Posted (Estimate)

January 10, 2017

Study Record Updates

Last Update Posted (Estimate)

January 10, 2017

Last Update Submitted That Met QC Criteria

January 6, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VEREO 3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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