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

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ClinicalTrials.gov Identifier: NCT03016507
Recruitment Status : Completed
First Posted : January 10, 2017
Last Update Posted : January 10, 2017
Sponsor:
Collaborator:
Francisco Welington Rodrigues
Information provided by (Responsible Party):
Rodrigo Egidio da Silva, VER Excelência em Oftalmologia

Brief Summary:
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.

Condition or disease
Intraocular Pressure Cataracts Senile

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.

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Study Type : Observational
Actual Enrollment : 100 participants
Time Perspective: Cross-Sectional
Official Title: Intraocular Pressure Variation by Pneumatic Tonometer Before and After Phacoemulsification
Study Start Date : July 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017



Primary Outcome Measures :
  1. Intraocular Pressure Variation by Pneumatic Tonometer Before and After Phacoemulsification [ Time Frame: Six months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
People with cataract and with good systemic health
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016507


Locations
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Brazil
Rodrigo Egidio da Silva
Goiania, GO, Brazil, 74180-010
Sponsors and Collaborators
VER Excelência em Oftalmologia
Francisco Welington Rodrigues
Publications:

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Responsible Party: Rodrigo Egidio da Silva, Ophtalmologist, VER Excelência em Oftalmologia
ClinicalTrials.gov Identifier: NCT03016507    
Other Study ID Numbers: VEREO 3
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rodrigo Egidio da Silva, VER Excelência em Oftalmologia:
intraocular pressure
phacoemulsification
cataract
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases