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AzTrials

KeratoconusNCT01691651

Botulinum Toxin A for the Treatment of Keratoconus

A study testing Subcutaneous injection of botulinum toxin type A and Botulinum Toxin Type A in people with Keratoconus, run by Federal University of São Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 10 to 40 years
Conditions the study is for
Keratoconus
What is being tested?
Subcutaneous injection of botulinum toxin type A and Botulinum Toxin Type A
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteBrazil
Study dates
Sep 2012to Oct 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 40 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Federal University of São Paulo, Department of Ophthalmology

    São Paulo, São Paulo, 04023-062

Other trials in Brazil

About this study

Official title: Botulinum Toxin Type A for Keratoconus

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.

Read the detailed 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.

Conditions
Keratoconus
Being tested
Subcutaneous injection of botulinum toxin type A, Botulinum Toxin Type A
Keywords
Keratoconus, Tetanus toxin
Medical subject headings
Keratoconus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Subcutaneous injection of botulinum toxin type AProcedure or surgery

    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.

  • Botulinum Toxin Type ADrug

    Also called Botox (Allergan)

    2.5 units per point of application at two points in a nasal and temporal extent of the orbicularis muscle.

Study groups in NCT01691651
Study groupRoleWhat they receive
Botulinum toxin type AActive comparatorThe group that will be subjected to the injection of botulinum toxin (subcutaneous injection of botulinum toxin type A).Subcutaneous botulinum toxin A injection will be performed in this group, (2.5 units per point application), at two points in a nasal and temporal extent of the orbicularis muscle.
Receives: Procedure: Subcutaneous injection of botulinum toxin type A; Drug: Botulinum Toxin Type A
ControlNo interventionThe group that will not be subjected to any intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Eighteen months.

Secondary outcomes (1)

  1. 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.

    Measured: Eighteen months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01691651
Sponsor's protocol ID
RECUNIFESP-87051
Status last verified
Oct 2014
First submitted
18 Sep 2012
Last updated
21 Oct 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Rabinowitz YS. Keratoconus. Surv Ophthalmol. 1998 Jan-Feb;42(4):297-319. doi: 10.1016/s0039-6257(97)00119-7.

    PubMed 9493273

  • Edwards M, McGhee CN, Dean S. The genetics of keratoconus. Clin Exp Ophthalmol. 2001 Dec;29(6):345-51. doi: 10.1046/j.1442-9071.2001.d01-16.x.

    PubMed 11778802

  • 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. doi: 10.3928/1081-597X-20031101-06.

    PubMed 14640429

  • 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.

    PubMed 19772256

  • 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. doi: 10.1016/s0002-9394(02)02220-1.

    PubMed 12719068

  • 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.

    PubMed 22265143

  • Bawazeer AM, Hodge WG, Lorimer B. Atopy and keratoconus: a multivariate analysis. Br J Ophthalmol. 2000 Aug;84(8):834-6. doi: 10.1136/bjo.84.8.834.

    PubMed 10906086

  • Kim T, Khosla-Gupta B, Debacker C. Blepharoptosis-induced superior keratoconus. Am J Ophthalmol. 2000 Aug;130(2):232-4. doi: 10.1016/s0002-9394(00)00497-9.

    PubMed 11004300

  • Parunovic A. Floppy eyelid syndrome. Br J Ophthalmol. 1983 Apr;67(4):264-6. doi: 10.1136/bjo.67.4.264.

    PubMed 6830745

  • Brown IA. Ankyloblepharon associated with keratoconus. Br J Ophthalmol. 1967 Feb;51(2):138-9. doi: 10.1136/bjo.51.2.138. No abstract available.

    PubMed 6018907

  • Cristina Kenney M, Brown DJ. The cascade hypothesis of keratoconus. Cont Lens Anterior Eye. 2003 Sep;26(3):139-46. doi: 10.1016/S1367-0484(03)00022-5.

    PubMed 16303509

  • Scott AB, Kennedy RA, Stubbs HA. Botulinum A toxin injection as a treatment for blepharospasm. Arch Ophthalmol. 1985 Mar;103(3):347-50. doi: 10.1001/archopht.1985.01050030043017.

    PubMed 3977705

  • 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. doi: 10.1590/s0004-27492006000100005. Epub 2006 Feb 10. Portuguese.

    PubMed 16491229

  • Nicoletti AG, Aoki L, Nahas TR, Matayoshi S. [Essential blepharospasm: literature review]. Arq Bras Oftalmol. 2010 Sep-Oct;73(5):469-73. doi: 10.1590/s0004-27492010000500018. Portuguese.

    PubMed 21225137

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

    PubMed 20590421

Questions about this trial

What is this clinical trial studying?

A study testing Subcutaneous injection of botulinum toxin type A and Botulinum Toxin Type A in people with Keratoconus, run by Federal University of São Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of the palpebral fissure (time frame: Eighteen months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01691651, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2014.

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