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Completed

NCT Number: NCT03016507

Intraocular Pressure Variation by Pneumatic Tonometer Before and After Phacoemulsification

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rodrigo Egidio da Silva

Goiânia, Goiás, 74180-010, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Intraocular Pressure Variation by Pneumatic Tonometer Before and After Phacoemulsification

    Time frame: Six months

Sponsors and collaborators

Lead sponsor

VER Excelência em Oftalmologia

Other

Collaborators

  • Francisco Welington Rodrigues

Registry information

Acronym: IPOFACO

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 10, 2017
Registry last updated
Jan 10, 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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