Tratamientos tópicos para blefaroqueratoconjuntivitis en niños
Información
- DOI:
- https://doi.org/10.1002/14651858.CD011965.pub2Copiar DOI
- Base de datos:
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- Cochrane Database of Systematic Reviews
- Versión publicada:
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- 07 febrero 2017see what's new
- Tipo:
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- Intervention
- Etapa:
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- Review
- Grupo Editorial Cochrane:
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Grupo Cochrane de Salud ocular y de la visión
- Copyright:
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- Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cifras del artículo
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Autores
Contributions of authors
MH, MOG and ADN developed the protocol, with critical review of the clinical sections by FL and ST and of the statistical sections by CB. MOG and ADN conducted the review of studies. MOG wrote the final manuscript with critical review by ADN.
Sources of support
Internal sources
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National Institute for Health Research (NIHR) Biomedical Research Centre, UK.
The research was supported by the NIHR Biomedical Research Centre based at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology. The views expressed are those of the review authors and not necessarily those of the NHS, the NIHR or the Department of Health.
External sources
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National Institute for Health Research (NIHR), UK.
Richard Wormald, Co‐ordinating Editor for Cochrane Eyes and Vision (CEV) acknowledges financial support for his CEV research sessions from the Department of Health through the award made by the NIHR to Moorfields Eye Hospital National Health Service (NHS) Foundation Trust and University College London Institute of Ophthalmology for a Specialist Biomedical Research Centre for Ophthalmology.
The NIHR also funds the CEV editorial base in London.
The views expressed in this publication are those of the review authors and not necessarily those of the NIHR, the NHS or the Department of Health.
Declarations of interest
MO'G has no known conflicts of interest.
CB has no known conflicts of interest.
MH has no known conflicts of interest.
FL has no known conflicts of interest.
ST has no known conflicts of interest.
ADN has no known conflicts of interest.
Acknowledgements
Cochrane Eyes and Vision created and executed the electronic search strategies. We thank Jimmy Le for his comments on the protocol (O'Gallagher 2015) and Samer Hamada for his comments on the protocol and review. We thank Jennifer Evans and Anupa Shah for their assistance throughout the protocol development.
Version history
| Published | Title | Stage | Authors | Version |
| 2017 Feb 07 | Topical treatments for blepharokeratoconjunctivitis in children | Review | Michael O'Gallagher, Catey Bunce, Melanie Hingorani, Frank Larkin, Stephen Tuft, Annegret Dahlmann‐Noor | |
| 2015 Nov 23 | Topical treatments for blepharokeratoconjunctivitis in children | Protocol | Michael O'Gallagher, Catey Bunce, Melanie Hingorani, Frank Larkin, Stephen Tuft, Annegret Dahlmann‐Noor | |
Differences between protocol and review
Our search of ClinicalTrials.gov identified a trial registry record, which we ascertained had been reported in a paper not identified by our MEDLINE search strategy (Comstock 2012). A search for the term blepharoconjunctivitis would have identified this paper. We amended the search strategy as detailed in the 'Methods' section. Some of the outcomes for the Summary of findings have changed from those of the proposed outline in Appendix 9 of the published protocol (O'Gallagher 2015).
Keywords
MeSH
Medical Subject Headings (MeSH) Keywords
- Administration, Topical;
- Anti‐Allergic Agents [*administration & dosage, adverse effects];
- Anti‐Bacterial Agents [*administration & dosage, adverse effects];
- Blepharitis [*drug therapy];
- Conjunctiva [microbiology];
- Eyelids [microbiology];
- Keratoconjunctivitis [*drug therapy];
- Loteprednol Etabonate [*administration & dosage];
- Randomized Controlled Trials as Topic;
- Tobramycin [*administration & dosage, adverse effects];
Medical Subject Headings Check Words
Child; Child, Preschool; Humans; Infant; Infant, Newborn;
PICO
Study flow diagram.
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
| Topical treatments compared with control for blepharokeratoconjunctivitis in children | ||||||
| Patient or population: children with blepharokeratoconjunctivitis Settings: eye clinic Intervention: topical treatments (antibiotics and/or steroids) Comparison: placebo | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | No of Participants | Certainty (quality) of the evidence | Comments | |
| Assumed risk | Corresponding risk | |||||
| placebo (vehicle) | topical treatments (antibiotics/steroids) | |||||
| Improvement in symptoms, reported by the child or by their parents/carers, preferably measured by a validated tool, at three months (± one month) after start of treatment | ‐ | ‐ | ‐ | 137 (1) | ⊕⊝⊝⊝ | Data on changes in grade of blepharoconjunctivitis measured between baseline and 2 weeks did not suggest any important differences between groups. |
| Elimination of all clinical signs of ocular surface inflammation ('complete success'), preferably measured by a composite grading system, at three months (± one month) after start of treatment | ‐ | ‐ | ‐ | ‐ | ‐ | Not reported |
| Improvement of clinical signs of ocular surface inflammation ('partial success'), preferably measured by a composite grading system, at three months (± one month) after start of treatment | ‐ | ‐ | ‐ | 137 (10 | ⊕⊝⊝⊝ | Data on changes in grade of blepharoconjunctivitis measured between baseline and 2 weeks did not suggest any important differences between groups. |
| Change from baseline in best corrected visual acuity in affected eye(s) in logMAR measured with an ETDRS chart at 4 m, or, in younger children, with a Keeler crowded logMAR chart at 3 m, at three months (± one month) after start of treatment | ‐ | ‐ | ‐ | 137 (1) | ⊕⊝⊝⊝ | Limited data in a form that could not be extracted; not statistically significant differences between groups. |
| Uncontrolled or poorly controlled disease progression due to treatment failure, at three months (± one month) after start of treatment | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Adverse effects of medication, at any time during treatment | Ocular adverse events
Non‐ocular adverse events
| 137 (1) | ⊕⊝⊝⊝ | |||
| Quality of life | ‐ | ‐ | ‐ | ‐ | ‐ | Not reported |
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1 Some data on blepharoconjunctivitis grade reported on trials registry but we were unable to estimate a measure of effect for this outcome. 2 Data were not fully reported and we were unable to estimate a measure of effect for change in visual acuity. 3 Very low certainty due to very low numbers of events. | ||||||
| Author, year | Study type | N | Age | Mean/median follow‐up | Mechanical treatment | Systemic (oral) interventions | Topical interventions | Physician‐reported outcomes | Patient‐reported outcomes | Adverse events from condition | Adverse events from treatment |
| Case series | 7 | 6 to 14 years | 6 months | Lid hygiene | Amoxicillin/ clavulanate | Chloramphenicol (PF) drops, chloramphenicol ointment to lids, prednisolone 0.5% (PF) | Eyelid condition, corneal epitheliopathy, stromal defects | Improvement of symptoms | None | None | |
| Case series | 3 | 30 months to 8 years | Variable | Lid hygiene | Azithromycin | Loteprednol 0.2%, CSA 0.05%, | Chalazia, keratitis, corneal ulcer/scar, phlyctenule, MGD | Improvement of itching | None | None | |
| Case series | 16 | 4 to 16 years | Variable | Lid hygiene | Erythromycin (1 participant only) | Azithromycin 1.5%, CSA 2% | Bulbar conjunctival hyperaemia, conjunctival phlycten, corneal inflammation, blepharitis grade | Ocular redness | None | Ocular irritation (redness, burning, stinging) | |
| Case series | 8 | 3.5 to 13 years | 8.3 months | Lid hygiene | Erythromycin suspension 450 mg divided into 3 doses | Prednisolone 0.5% (PF); hydrocortisone acetate 1% ointment nocte | Bulbar conjunctival redness, inferior superficial corneal vascularisation, punctate corneal epithelial staining, inferior subepithelial vascularisation and infiltrate, conjunctival phlyctenules, corneal phlyctenules, circumferential pannus, corneal scar | Red eyes, photophobia, itching, discharge | Corneal scarring and thinning | Stomach disturbance, diarrhoea | |
| Case series | 615 | 7 months to 16 years | Not reported | Lid hygiene | Erythromycin | Topical steroids and antibiotics (not specified) | Outcomes not reported (presenting signs only) | Outcomes not reported (presenting symptoms only) | None | None | |
| Case series | 10 | 6 to 27 years | 4.4 years | Lid hygiene | Azathioprine, mycophenolate mofetil, prednisolone | Steroids (not specified) | Disease remission/ control of inflammation | None | Corneal perforation | none | |
| Case series | 29 | 2 to 12 years | 5.4 months | Warm compresses | Erythromycin, doxycyclin | Prednisolone 1%, dexamethasone 0.1%, antibiotic, fluorometholone, loteprednol etabonate 0.5% | Eyelid inflammation, superficial punctate keratitis, corneal vascularisation, corneal infiltrates, phlyctenules, corneal scarring | None | Amblyopia | Gastrointestinal distress, mouth ulcers (unrelated) | |
| Case series | 27 | 7 months to 15.9 years | 2.3 years | Warm compresses, lid hygiene | Erythromycin, doxycyclin, flaxseed oil | chloramphenicol, ciprofloxacin, gentamicin, prednisolone 1% or 0.5%, fluorometholone 0.1% | Visual acuity, astigmatism | Discomfort, photophobia | Amblyopia | Vaginal candidiasis | |
| Case series | 5 | 4 to 9 years | Not specified | Erythromycin | Lid hyperaemia and swelling, corneal infiltrates | None | None | None | |||
| Case series | 114 | Mean 9.3 years (± 4.2) | 26.4 months | Lid hygiene | Flaxseed oil, erythromycin | Lubricants (hyaluronate, methylcellulose), erythromycin, ciprofloxacin, steroids (dexamethasone 0.1% (PF), loteprednol 0.5%, fluorometholone 0.1%), CSA 0.05% | Visual acuity | None | None reported | None reported | |
| Case series | 51 | Mean 10.2 years (± 3.6) | 58.9 months | Warm compresses, lid hygiene | Antibiotics (erythromycin, amoxicillin/ clavulanate, doxycycline), steroids | Steroids (dexamethasone 1%, prednisolone 0.12 to 1%, fluorometholone 0.1%) , antibiotics (fucidic acid, levofloxacin, tobramycin), CSA 0.5% | Visual acuity | Redness, tearing, blurred vision, pain, irritation, photophobia, white spot, swelling, discharge, itching, rubbing | Corneal perforation | Raised intraocular pressure, cataract, gastrointestinal disturbance | |
| Case series | 44 | 1 to 14 years | 7 years | Lid hygiene | Erythromycin | Chloramphenicol, steroids | Reduction of clinical signs | Redness, watering, itching, grittiness, discharge, photophobia, pain | None reported | None reported | |
| Abbreviations: CSA: ciclosporin | |||||||||||
| Author, year | Study type | N | Age | Mean/median follow‐up | Mechanical treatment | Systemic (oral) interventions | Topical interventions | Physician‐reported outcomes | Patient‐reported outcomes | Adverse events from condition | Adverse events from treatment |
| RCT | 137 | 0 to 6 years | 15 days | None | None | Loteprednol 0.5% , tobramycin 0.3% | Visual acuity | None | None | Eye pain, conjunctivitis, eye discharge, and eye inflammation | |
| RCT | Total 417; 19 children | Not specified | 15 days | None | None | Azithromycin 1%, dexamethasone 0.1% | Complete bacterial eradication from conjunctiva and eyelids, complete resolution of clinical signs | Complete resolution of symptoms | None | Eye disorder, reduced visual acuity, punctate keratitis, blurred vision, conjunctival oedema, discharge, lid oedema, irritation, pain, itching | |
| RCT | Total 71; number of children not specified | 10 to 86 years | 14 to 15 days | None | None | Gentamycin 0.3%, betamethasone 0.1% | Ocular sign score, specific ocular inflammatory signs, bacterial eradication | None | None | Conjunctival hyperaemia | |
| Abbreviations: N: number of participants | |||||||||||
| Follow‐up | Loteprednol Etabonate and Tobramycin | Loteprednol Etabonate | Tobramycin | Vehicle |
| Mean (SD) N | Mean (SD) N | Mean (SD) N | Mean (SD) N | |
| Day 3 | ‐7.32 (3.27) 34 | ‐7.74 (3.90) 34 | ‐5.94 (4.00) 32 | ‐6.58 (3.46) 31 |
| Day 7 | ‐11.03 (3.20) 34 | ‐10.94 (4.69) 34 | ‐9.90 (3.80) 30 | ‐10.03 (4.63) 30 |
| Day 15 | ‐11.41 (3.29) 34 | ‐11.23 (3.98) 35 | ‐10.68 (4.71) 34 | ‐10.30 (5.19) 33 |
| Loteprednol/tobramycin | Loteprednol | Tobramycin | Vehicle | |
| Ocular AEs | 1/34 (eye pain) | 4/35 (eye pain, conjunctivitis, eye discharge, eye inflammation) | 0/34 | 0/33 |
| Non‐Ocular AEs | 2/34 3 AEs (gastroenteritis, pyrexia, bronchiolitis) | 6/35 9 AEs (ear infection, lip swelling, vomiting, URI, varicella, cough, phyarngolaryngeal pain, rash) | 6/34 9 AEs (ear infection, otitis media acute, diarrhea, pyrexia, bronchioltis, URI, nasophayngitis, respirator distress, dermatitis (diaper) ) | 5/33 7 AEs (ear pain, pyrexia, urticaria, bronchioloitis, URI, tonsilitis, dehydration) |
| Abbreviations: AEs: adverse events | ||||
