RecruitingACTRN12606000365561

Central Corneal Thickness in Aphakic Children and with Congenital Cataract: a Case-Control Study

The Influence of Central Corneal Thickness on Applanation and Dynamic Contour Tonometries in aphakic children and with congenital cataract: a case-control study


Sponsor

Dr. Vital Paulino Costa

Enrollment

30 participants

Start Date

Aug 3, 2006

Study Type

Observational

Conditions

Summary

Bilateral congenital cataract is the most common cause of reversible children blindness around the world. Although, Secondary glaucoma is the most frequent complication following cataract extraction in these children, reaching an incidence of 10%, enhancing the great importance of precise diagnosis and adequate follow-up. Central corneal thickness is one of the factors that interferes with the aplanation tonometry measurement. It has been observed post-operativelly, that these children have a thicker cornea, especially the aphakic ones. Eventhough, the nature of these findings is still unknown. Since intra-ocular pressure is of great importance on glaucoma treating decisions, central corneal thickness becomes an important information on the follow-up of children with cataract. The study objectives are: to compare central corneal thickness of normal children with (1) children with cataract, (2) aphakic children and (3) follow-up central corneal thickness pre and postoperatively of children with congenital cataract. The study design is a case-control study which will take place at the Ophthalmology Department of the State University of Campinas. Children with congenital cataract, normal and aphakic children will be recruited after obtaining their parents informed consent. Measurements of ultrasonic pachymetry, Goldmann aplanation tonometry and dynamic contour tonometry will be taken. There will be five fases of the study: The study will be divided into five fases: (1) transversal case-control study of bilateral aphakic children, (2) transversal case-control study of children with bilateral congenital cataract, (3) transversal case-control study of unilateral aphakic children, (4) transversal case-control study of children with unilateral congenital cataract children and (5) prospective longitudinal study of facectomized children.


Eligibility

Sex: Both males and females

Plain Language Summary

Simplified for easier understanding

This study is looking at corneal thickness (the thickness of the clear front part of the eye) in children who were born with cataracts (cloudy lenses in the eye). Congenital cataracts are the leading cause of treatable childhood blindness worldwide. A common complication after cataract surgery in children is a condition called glaucoma, where pressure inside the eye becomes too high. Corneal thickness affects how we measure eye pressure, so it is important to understand this in children who have had cataract surgery. This study compares corneal thickness in children with cataracts, children who have already had cataract surgery, and children with normal eyes. You may be eligible if: - You are a child with a cataract in one or both eyes, OR - You are a child who has already had cataract surgery (aphakic or pseudophakic) You may NOT be eligible if: - You have glaucoma - You have had any eye surgery other than cataract removal - You have had laser treatment on your eyes - You have had an eye injury - You have a secondary (acquired) cataract Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Interventions which will be done on every included children: - US-Pachymetry: after topical or inhalation general anesthesia (depending on children colaboration to exam) central corneal thickness w

Interventions which will be done on every included children: - US-Pachymetry: after topical or inhalation general anesthesia (depending on children colaboration to exam) central corneal thickness will be measured with Micropach 200P+ (Sonomed, Lake Success, New York, USA). - Applanation Tonometry: after topical or inhalation general anesthesia (depending on children colaboration to exam) applanation tonometry will be done with a Haag-Streit Goldmann Applanation Tonometer model R900 (Haag-Streit, Koeniz, Switzerland) or with a Clement Clark International Perkins Applanation Tonometer (Clement Clark International ltd, London, England) respectivelly. - Dynamic Contour Tonometry: on collaborative children, dynamic contour tonometry will be done with topical anesthesia with the PASCAL Dynamic Contour Tonometer (model 311.011.002 - SMT Swiss Microtechnology - Port - Switzewrland). Time that the measures will be done: - Longitudinal Branch: measures will be taken from children with congenital cataract pre and postoperativelly after 6 and 12 months of surgery (named T0, T6 and T12 respectivelly). -Tranversal Branch: measures will be taken from aphakic children due to previous cataract extraction. Unilateral Cataract or Aphakia: children under this condition will be included as self-control, once one eye is a case and the other eye will be the control. Bilateral Cataract or Aphakia: children under this condition will have a paired control of the same gender, age and ethinic group.


Locations(1)

Brazil

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ACTRN12606000365561


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