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Completed

NCT Number: NCT02816905

Ocular-hypertensive Response to Topical Steroids in Children After Bilateral Strabismus Surgery

This study aims to compare the effects of topical (Rimexolone versus Dexamethasone) on the IOP in children under 13 years of age who underwent bilateral strabismus surgery, and to compare the effects of topical (Rimexolone versus Fluorometholone) on the IOP in the children under 13 years of age who underwent bilateral strabismus surgery.

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Key information

Age range

Up to 13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cairo University Hospitals

Cairo, Egypt

About this study

Children under the age of 13 years undergoing bilateral strabismus surgery in Cairo University Hospitals (Cairo University Specialized Pediatric Hospital and Kasr Al Ainy Hospital). will be randomized using simple randomization method, computer software for randomization, into two equal groups:

  • First group: One eye is randomized to receive topical 0.1% Dexamethasone, whereas the fellow eye will receive topical 1% Rimexolone four times per day for 2 weeks.
  • Second group: One eye is randomized to receive topical 0.1% Fluorometholone, whereas the fellow eye will receive topical 1% Rimexolone four times per day for 2 weeks.

IOP will be measured on the day before operation using the Tono-Pen®. Three reliable measurements will be obtained from each eye and the mean will be taken.

IOP will be measured at postoperative weeks 1, 2, 3, 4 and 6 using the Tono-Pen®.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children younger than 13 years of age.
  • Children who underwent bilateral recession strabismus surgeries.
  • Preoperative IOP of 21.00 mmHg or less, with a cup-disc ratio of 0.3 or less.
  • The absence of systemic disease and ocular disease (apart from strabismus) in both eyes.
  • Children who can comply with the IOP measurements using the Tono-Pen®, as no type of anesthesia will be used, except for the topical anesthesia.

Exclusion criteria

  • Patients that are 13 years of age or older.
  • Children who need resection muscle surgeries, surgeries for the vertical, or the oblique muscles.
  • Preoperative IOP of more than 21.00 mmHg, or a cup-disc ratio of more than 0.3
  • Family history of glaucoma or high myopia.
  • A history of steroid usage in the past year.
  • Failure to comply with IOP measurements or the follow-up schedule.

Treatment and study plan

0.1 % Dexamethasone

Drug

20 eyes are randomized to receive topical 0.1% Dexamethasone four times per day for 2 weeks.

Other names: Topical steroid

0.1% Fluorometholone

Drug

20 eyes are randomized to receive topical 0.1% Fluorometholone four times per day for 2 weeks.

Other names: Topical steroid

1% Rimexolone

Drug

40 eyes are randomized to receive topical 1% Rimexolone four times per day for 2 weeks. 20 of these eyes were the contralateral eyes of the patients who received 0.1% Dexamethasone in their first eye. The other 20 eyes were the contralateral eyes of the patients who received 0.1% Fluorometholone in their first eye

Other names: Topical steroid

Primary outcomes

  1. Measuring the rise in intraocular pressure using the Tono-Pen® after topical steroids are used in children under 12 years of age, who underwent bilateral strabismus surgery

    Time frame: IOP will be followed up for 6 weeks after initial use

    Measuring the rise in intraocular pressure using the Tono-Pen® after topical steroid use in children. IOP will be measured at postoperative weeks 1, 2, 3, 4 and 6. And will be compared with pre-operative values.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Ocular-hypertensive Response to Topical Steroids in Children After Bilateral Strabismus Surgery (Topical Rimexolone Versus Topical Dexamethasone and Topical Fluorometholone)

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 29, 2016
Registry last updated
Jun 29, 2016

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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