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Trial registered on ANZCTR


Registration number
ACTRN12606000365561
Ethics application status
Approved
Date submitted
10/08/2006
Date registered
22/08/2006
Date last updated
14/03/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Central Corneal Thickness in Aphakic Children and with Congenital Cataract: a Case-Control Study
Scientific title
The Influence of Central Corneal Thickness on Applanation and Dynamic Contour Tonometries in aphakic children and with congenital cataract: a case-control study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congenital cataract 1334 0
Condition category
Condition code
Eye 1422 1422 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 1273 0
Diagnosis / Prognosis
Comparator / control treatment
central corneal thickness; IOP
Control group
Active

Outcomes
Primary outcome [1] 1943 0
Central Coneal Thickness
-transversal branch
Timepoint [1] 1943 0
Measure will be done at the only exam on the inclusion date
Primary outcome [2] 1944 0
Central Coneal Thickness
-longitudinal branch
Timepoint [2] 1944 0
Measures will be done at the preoperatory examination and after 6 and 12 month of cataract extraction.
Secondary outcome [1] 3404 0
Transversal branch:
Applanation Tonometry
Dynamic Contour Tonometry
Timepoint [1] 3404 0
Measure will be done at the only exam on the inclusion date.
Secondary outcome [2] 3405 0
Longitudinal branch:
Applanation Tonometry
Dynamic Contour Tonometry
Timepoint [2] 3405 0
Measures will be done at the preoperatory examination and after 6 and 12 month of cataract extraction.

Eligibility
Key inclusion criteria
- congenital cataract in one or both eyes
- previous congenital cataract extraction in one or both eyes (aphakic or pseudophakic)
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- glaucoma
- previous intraocular surgery (other than cataract extraction)
-previous ocular laser treatment
-history of ocular trauma
-secondary cataract

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 385 0
Brazil
State/province [1] 385 0

Funding & Sponsors
Funding source category [1] 1554 0
University
Name [1] 1554 0
Ophthalmology Department of the State University of Campinas
Country [1] 1554 0
Brazil
Primary sponsor type
Individual
Name
Dr. Vital Paulino Costa
Address
Dept. Otorrino-Oftalmologia da UNICAMP
R. Tessalia Vieira de Camargo, 126
Cidade Universitária - Campinas - SP
CEP 13084-970 - Brasil
Country
Brazil
Secondary sponsor category [1] 1367 0
None
Name [1] 1367 0
nil
Address [1] 1367 0
Country [1] 1367 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2985 0
Brazillian National System of Research Ethics
Ethics committee address [1] 2985 0
R. Tessalia Vieira de Camargo, 126
Caixa Postal 6111
Cidade Universit?ria - Campinas - SP
CEP 13084-971 - Brasil
Ethics committee country [1] 2985 0
Brazil
Date submitted for ethics approval [1] 2985 0
Approval date [1] 2985 0
Ethics approval number [1] 2985 0
248/2006
Ethics committee name [2] 2986 0
Research Ethics Comitee of the Medical Sciences School of the State University of Campinas
Ethics committee address [2] 2986 0
R. Tessalia Vieira de Camargo, 126
Caixa Postal 6111
Cidade Universit?ria - Campinas - SP
CEP 13084-971 - Brasil
Ethics committee country [2] 2986 0
Brazil
Date submitted for ethics approval [2] 2986 0
Approval date [2] 2986 0
Ethics approval number [2] 2986 0
248/2006

Summary
Brief 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.
Trial website
Trial related presentations / publications
Central corneal thickness in eyes with
congenital cataract and aphakic eyes due to congenital cataract: a case-control study
-poster: XII Brazilian Glaucoma Society Simposyum
-poster: 27th Panamerican Congress of Ophthalmology
-poster: 6th Iinternational Glaucoma Simposyum
Public notes

Contacts
Principal investigator
Name 35652 0
Address 35652 0
Country 35652 0
Phone 35652 0
Fax 35652 0
Email 35652 0
Contact person for public queries
Name 10462 0
Alvaro Lupinacci
Address 10462 0
271 N Lauderdale St apt 101
Memphis, TN - USA
ZIP 38105
Country 10462 0
United States of America
Phone 10462 0
1-901-577-9448
Fax 10462 0
Email 10462 0
[email protected]
Contact person for scientific queries
Name 1390 0
Alvaro Lupinacci
Address 1390 0
271 N Lauderdale St apt 101
Memphis, TN - USA
ZIP 38105
Country 1390 0
United States of America
Phone 1390 0
1-901-577-9448
Fax 1390 0
Email 1390 0
[email protected]

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