Botulinum Toxin A for the Treatment of Keratoconus

Keratoconus Clinical Trial

Official title:

Botulinum Toxin Type A for Keratoconus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01691651
• Other study ID #: RECUNIFESP-87051
• Status: Completed
• Phase: N/A
• First received: September 18, 2012
• Last updated: October 18, 2014
• Start date: September 2012
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to associate the use of botulinum toxin type A for patients with keratoconus to demonstrate that tension eyelid has an important role in disease progression.

Description:

Subcutaneous injection of botulinum toxin type A will be performed at two points in a nasal and temporal extent of the orbicularis muscle of a group of patients with keratoconus (Botulinum toxin A group).The idea is to evaluate the change in palpebral fissure in patients from group botulinum toxin A over a period of 18 months.The measurements of the palpebral fissure will be performed by the Image J (version 1.34s) program, developed by the National Institutes of Health (USA).The unit of measure is the millimetre.The patients of the botulinum toxin A group will be compared with a control group, without any intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 40 Years

Eligibility

Inclusion Criteria:

• patients with documented keratoconus

• best-corrected visual acuity measurable at refraction test

• age between 10-40 years

• good health

• understand the procedure and its limitations

Exclusion Criteria:

• only one functional eye

• previous ocular surgery

• concurrent corneal infection and other ocular diseases that modified the visual acuity

• known allergy to botulinum toxin

• pregnancy

• poor collaboration for performing the examinations and the procedure

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Keratoconus

Intervention

Procedure:
• Subcutaneous injection of botulinum toxin type A
Subcutaneous injection of botulinum toxin type A (2.5 units per application point) at two points in a nasal and temporal extent of the orbicularis muscle will be performed in the Botulinum toxin type A group.

Drug:
• Botulinum Toxin Type A
2.5 units per point of application at two points in a nasal and temporal extent of the orbicularis muscle.

Locations

Country	Name	City	State
Brazil	Federal University of São Paulo, Department of Ophthalmology	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (16)

Bawazeer AM, Hodge WG, Lorimer B. Atopy and keratoconus: a multivariate analysis. Br J Ophthalmol. 2000 Aug;84(8):834-6. — View Citation

Brown IA. Ankyloblepharon associated with keratoconus. Br J Ophthalmol. 1967 Feb;51(2):138-9. — View Citation

Coscarelli JM. Essential blepharospasm. Semin Ophthalmol. 2010 May;25(3):104-8. doi: 10.3109/08820538.2010.488564. Review. — View Citation

Cristina Kenney M, Brown DJ. The cascade hypothesis of keratoconus. Cont Lens Anterior Eye. 2003 Sep;26(3):139-46. — View Citation

Edwards M, McGhee CN, Dean S. The genetics of keratoconus. Clin Experiment Ophthalmol. 2001 Dec;29(6):345-51. Review. — View Citation

Kim T, Khosla-Gupta B, Debacker C. Blepharoptosis-induced superior keratoconus. Am J Ophthalmol. 2000 Aug;130(2):232-4. — View Citation

Krumeich JH, Daniel J, Knülle A. Live-epikeratophakia for keratoconus. J Cataract Refract Surg. 1998 Apr;24(4):456-63. — View Citation

Kymionis GD, Kontadakis GA, Kounis GA, Portaliou DM, Karavitaki AE, Magarakis M, Yoo S, Pallikaris IG. Simultaneous topography-guided PRK followed by corneal collagen cross-linking for keratoconus. J Refract Surg. 2009 Sep;25(9):S807-11. doi: 10.3928/1081597X-20090813-09. Epub 2009 Sep 11. — View Citation

Miranda D, Sartori M, Francesconi C, Allemann N, Ferrara P, Campos M. Ferrara intrastromal corneal ring segments for severe keratoconus. J Refract Surg. 2003 Nov-Dec;19(6):645-53. — View Citation

Nicoletti AG, Aoki L, Nahas TR, Matayoshi S. [Essential blepharospasm: literature review]. Arq Bras Oftalmol. 2010 Sep-Oct;73(5):469-73. Review. Portuguese. — View Citation

Parunovic A. Floppy eyelid syndrome. Br J Ophthalmol. 1983 Apr;67(4):264-6. — View Citation

Rabinowitz YS. Keratoconus. Surv Ophthalmol. 1998 Jan-Feb;42(4):297-319. Review. — View Citation

Renesto Ada C, Melo LA Jr, Sartori Mde F, Campos M. Sequential topical riboflavin with or without ultraviolet a radiation with delayed intracorneal ring segment insertion for keratoconus. Am J Ophthalmol. 2012 May;153(5):982-993.e3. doi: 10.1016/j.ajo.2011.10.014. Epub 2012 Jan 20. — View Citation

Schellini SA, Matai O, Igami TZ, Padovani CR, Padovani CP. [Essential blepharospasm and hemifacial spasm: characteristic of the patient, botulinum toxin A treatment and literature review]. Arq Bras Oftalmol. 2006 Jan-Feb;69(1):23-6. Epub 2006 Feb 10. Review. Portuguese. — View Citation

Scott AB, Kennedy RA, Stubbs HA. Botulinum A toxin injection as a treatment for blepharospasm. Arch Ophthalmol. 1985 Mar;103(3):347-50. — View Citation

Wollensak G, Spoerl E, Seiler T. Riboflavin/ultraviolet-a-induced collagen crosslinking for the treatment of keratoconus. Am J Ophthalmol. 2003 May;135(5):620-7. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Corrected visual acuity	We will evaluate the corrected visual acuity (unit of measure=logMAR)by 18 months.These time points will be included:baseline, 3, 6, 12 and 18 months.	Eighteen months.	No
Primary	Measurement of the palpebral fissure	We will evaluate the change in palpebral fissure (unit of measure=millimetre)by 18 months.These time points will be included:baseline, 3, 6, 12 and 18 months.	Eighteen months.	No
Secondary	Corneal topography	We will evaluate corneal topography [flattest keratometry, steepest keratometry and average keratometry(unit of measure=diopters)]by 18 months.These time points will be included:baseline, 3, 6,12 and 18 months.	Eighteen months.	No

External Links

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