Pharmacologic versus Optical Penalisation in the treatment of Amblyopia
| ISRCTN | ISRCTN89210627 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89210627 |
| Secondary identifying numbers | 04/0643 |
- Submission date
- 22/09/2007
- Registration date
- 10/10/2007
- Last edited
- 23/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Jaime Tejedor
Scientific
Scientific
Ctra Colmenar km 9100
Madrid
28034
Spain
| Phone | +34 91 336 9008 |
|---|---|
| jtejedor.hrc@salud.madrid.org |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Pharmacologic versus Optical Penalisation in the treatment of Amblyopia |
| Study acronym | POPA |
| Study objectives | Amblyopia may be differentially treated with pharmacologic and optical penalisation. |
| Ethics approval(s) | Ethics Committee of Hospital Ramon y Cajal approved the study on the 15th June 2007 (ref: PI 04/0643). |
| Health condition(s) or problem(s) studied | 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 Atropine will be withdrawn when visual acuity remains equal in the amblyopic and sound eye in two consecutive follow-up visits, but monitoring without treatment will continue.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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Atropine |
| Primary outcome measure | Lines of improvement of visual acuity of the amblyopic eye at 6 months. |
| Secondary outcome measures | Stereoacuity measurement at 6 months. |
| Overall study start date | 01/11/2007 |
| Completion date | 01/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 10 Years |
| Sex | Both |
| Target number of participants | 35 in each group (total 70) |
| Total final enrolment | 70 |
| Key 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 |
| Key exclusion criteria | 1. Previous amblyopia treatment 2. Previous eye surgery 3. Ocular disease |
| Date of first enrolment | 01/11/2007 |
| Date of final enrolment | 01/10/2008 |
Locations
Countries of recruitment
- Spain
Study participating centre
Ctra Colmenar km 9100
Madrid
28034
Spain
28034
Spain
Sponsor information
Hospital Ramon y Cajal (Spain)
Hospital/treatment centre
Hospital/treatment centre
Ctra Colmenar km 9100
Madrid
28034
Spain
| Phone | +34 91 336 8000 |
|---|---|
| hrc@hrc.es | |
| Website | http://www.hrc.es/ |
"ROR" |
https://ror.org/050eq1942 |
Funders
Funder type
Government
Research Funding Agency of the Spanish Ministry of Health (Fondo de Investigacion Sanitaria [FIS]) (Spain) (ref: 040643)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2008 | 23/05/2019 | Yes | No |
Editorial Notes
23/05/2019: Publication reference and total final enrolment added.
