Condition category
Eye Diseases
Date applied
22/09/2007
Date assigned
10/10/2007
Last edited
10/10/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jaime Tejedor

ORCID ID

Contact details

Ctra Colmenar km 9100
Madrid
28034
Spain
+34 91 336 9008
jtejedor.hrc@salud.madrid.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

04/0643

Study information

Scientific title

Acronym

POPA

Study hypothesis

Amblyopia may be differentially treated with pharmacologic and optical penalisation.

Ethics approval

Ethics Committee of Hospital Ramon y Cajal approved the study on the 15th June 2007 (ref: PI 04/0643).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Amblyopia

Intervention

70 children 2 to 10 years of age are randomised to atropine or optical penalisation for the treatment of amblyopia.

1% atropine (Colircusi Atropina 1%, AlconCusi, Barcelona, Spain) will be prescribed twice a week when interocular acuity difference is present, and once a week for maintenance therapy (equal visual acuity in both eyes) until the next follow-up visit. Atropine will be withdrawn when visual acuity remains equal in the amblyopic and sound eye in two consecutive follow-up visits, but monitoring without treatment will continue. Atropine will be discontinued when allergy or intolerance occurs, and when reverse amblyopia is suspected. Sunglasses will be used at discretion of the child and family. Atropine will be interrupted within one week before follow-up examination, to measure visual acuity and maintain some cycloplegic effect, and the ability to monitor compliance by dynamic retinoscopy.

Optical penalisation will be achieved by positive defocus of the sound eye (overplus glass). Using a vectographic projector showing the 20/50 letter at a distance where the amblyopic eye can read it, the patient wears polaroid glasses over best correction in a trial frame. Sphere is added to the sound eye until the patient can read only letters seen by the amblyopic eye. We will use the minimal amount of defocus necessary, checked by fixation switch to the amblyopic eye at distance using this control (in children with strabismic deviation vectographic control is not necessary). Optical penalisation will be carefully checked and readjusted if necessary in every follow-up visit. Defocus will be discontinued when visual acuity remains equal in the amblyopic and sound eye for two consecutive visits, and visual acuity will continue to be monitored.

Follow-up will be scheduled with intervals of 2 - 6 months, depending on the severity of amblyopia and response to treatment. At least two follow-up visits will be required during the 6 month period of the study. The outcome measures will be determined at 6 months (i.e., after 6 months of treatment).

Intervention type

Drug

Phase

Not Specified

Drug names

Atropine

Primary outcome measures

Lines of improvement of visual acuity of the amblyopic eye at 6 months.

Secondary outcome measures

Stereoacuity measurement at 6 months.

Overall trial start date

01/11/2007

Overall trial end date

01/10/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 2 - 10 years
2. Ability to cooperate with measurement of visual acuity by the logarithmic Minimal Angle Resolution (logMAR) crowded test with at least 2 logMAR lines of difference in visual acuity between the two eyes

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

35 in each group (total 70)

Participant exclusion criteria

1. Previous amblyopia treatment
2. Previous eye surgery
3. Ocular disease

Recruitment start date

01/11/2007

Recruitment end date

01/10/2008

Locations

Countries of recruitment

Spain

Trial participating centre

Ctra Colmenar km 9100
Madrid
28034
Spain

Sponsor information

Organisation

Hospital Ramon y Cajal (Spain)

Sponsor details

Ctra Colmenar km 9100
Madrid
28034
Spain
+34 91 336 8000
hrc@hrc.es

Sponsor type

Hospital/treatment centre

Website

http://www.hrc.es/

Funders

Funder type

Government

Funder name

Research Funding Agency of the Spanish Ministry of Health (Fondo de Investigacion Sanitaria [FIS]) (Spain) (ref: 040643)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes