ANZCTR - Registration

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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

Condition category

Condition code

Eye

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]

Diagnosis / Prognosis

Comparator / control treatment

central corneal thickness; IOP

Control group

Active

Outcomes

Primary outcome [1]

Central Coneal Thickness
-transversal branch

Timepoint [1]

Measure will be done at the only exam on the inclusion date

Primary outcome [2]

Central Coneal Thickness
-longitudinal branch

Timepoint [2]

Measures will be done at the preoperatory examination and after 6 and 12 month of cataract extraction.

Secondary outcome [1]

Transversal branch:
Applanation Tonometry
Dynamic Contour Tonometry

Timepoint [1]

Measure will be done at the only exam on the inclusion date.

Secondary outcome [2]

Longitudinal branch:
Applanation Tonometry
Dynamic Contour Tonometry

Timepoint [2]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Brazil

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Ophthalmology Department of the State University of Campinas

Address [1]

R. Tessalia Vieira de Camargo, 126
Cidade Universit?ria - Campinas - SP
CEP 13084-970 - Brasil

Country [1]

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]

None

Name [1]

nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Brazillian National System of Research Ethics

Ethics committee address [1]

R. Tessalia Vieira de Camargo, 126
Caixa Postal 6111
Cidade Universit?ria - Campinas - SP
CEP 13084-971 - Brasil

Ethics committee country [1]

Brazil

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

248/2006

Ethics committee name [2]

Research Ethics Comitee of the Medical Sciences School of the State University of Campinas

Ethics committee address [2]

R. Tessalia Vieira de Camargo, 126
Caixa Postal 6111
Cidade Universit?ria - Campinas - SP
CEP 13084-971 - Brasil

Ethics committee country [2]

Brazil

Date submitted for ethics approval [2]

Approval date [2]

Ethics approval number [2]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Alvaro Lupinacci

Address

271 N Lauderdale St apt 101
Memphis, TN - USA
ZIP 38105

Country

United States of America

Phone

1-901-577-9448

Fax

alvaro.lupinacci@gmail.com

Contact person for scientific queries

Name

Alvaro Lupinacci

Address

271 N Lauderdale St apt 101
Memphis, TN - USA
ZIP 38105

Country

United States of America

Phone

1-901-577-9448

Fax

alvaro.lupinacci@gmail.com

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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