Corneal Cross-linking and Refractive Surface Ablation in Patients With Asymmetric Corneas

NCT02943967 | Completed

• 1 other identifier: 2088/88
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate safety and efficacy of corneal cross-linking and photorefractive keratectomy for refractive correction in patients with bilateral asymmetric topography.

Conditions

Surgical Procedure, Unspecified

Keywords

Refractive Surgical Procedures; Photorefractive Keratectomy; Aberrometry

Outcome Measures

Primary Outcomes (1)

• Refractive results - spherical equivalent in diopters

  30 months

Secondary Outcomes (5)

• Biomicroscopy findings with the slit lamp

  30 months

• Visual acuity in logMar

  30 months

• Aberrometric Results in root mean square

  18 months

• Topographic results in diopters

  30 months

• Pachymetric results in micra

  30 months

Study Arms (2)

CXL + PRK group

ACTIVE COMPARATOR

Corneal cross-linking surgery is perfomed in one eye : deepithelization of the cornea and instillation of 0,1% riboflavin (ophthalmos - Brazil) for 30 minutes and UVA for irradiated for 30 minutes with ultraviolet-A of 365nm light with an irradiance of 3 mW/cm2 using Xlink (Opto - São Carlos) Photorefractive keratotomy will be perfomed in the same eye using excimer laser Ladarvision (Alcon - USA) with 0,02 % mitomicin for 30 seconds (Ophthalmos - Brasil) simultaneously with the other eye. Both procedures will have the same post operative treatment : gatifloxacin 0,3% 6/6h for 10 days prednisolone acetate 0,12% 6/6h por 14 days

Procedure: CXL + PRK group

PRK group

ACTIVE COMPARATOR

Photorefractive keratotomy will be perfomed in the fellow eye using excimer laser Ladarvision (Alcon - USA) with 0,02 % mitomicin for 30 seconds (Ophthalmos - Brasil) simultaneously with the other eye. Both procedures will have the same post operative treatment : gatifloxacin 0,3% 6/6h for 10 days prednisolone acetate 0,12% 6/6h por 14 days

Procedure: PRK group

Interventions

CXL + PRK group PROCEDURE

Corneal cross-linking with subsequent photorefractive keratotomy after 6 months was performed in one eye

CXL + PRK group

PRK group PROCEDURE

Photorefractive keratotomy alone was performed in contra lateral eyes

PRK group

Eligibility Criteria

• Age: 23 Years - 51 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• bilateral asymmetric topography with inferior steepening
• corneal thickness of 440 micra at the thinnest point
• inferior-to-superior index (I-S) between 1.0D and 1.4D
• maximum keratometric steepness \< 47.00D
• stable refraction more than 1 year.

You may not qualify if:

• forme fruste keratoconus and keratoconus
• previous eye surgery
• previous eye trauma
• confirmed pregnancy

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of São Paulo

São Paulo, São Paulo, 04023-062, Brazil

Location

Related Publications (13)

• Cheema AS, Mozayan A, Channa P. Corneal collagen crosslinking in refractive surgery. Curr Opin Ophthalmol. 2012 Jul;23(4):251-6. doi: 10.1097/ICU.0b013e3283543cbd.

  PMID: 22569468 BACKGROUND

• Raiskup F, Theuring A, Pillunat LE, Spoerl E. Corneal collagen crosslinking with riboflavin and ultraviolet-A light in progressive keratoconus: ten-year results. J Cataract Refract Surg. 2015 Jan;41(1):41-6. doi: 10.1016/j.jcrs.2014.09.033.

  PMID: 25532633 BACKGROUND

• Carones F, Vigo L, Scandola E, Vacchini L. Evaluation of the prophylactic use of mitomycin-C to inhibit haze formation after photorefractive keratectomy. J Cataract Refract Surg. 2002 Dec;28(12):2088-95. doi: 10.1016/s0886-3350(02)01701-7.

  PMID: 12498842 BACKGROUND

• Randleman JB, Woodward M, Lynn MJ, Stulting RD. Risk assessment for ectasia after corneal refractive surgery. Ophthalmology. 2008 Jan;115(1):37-50. doi: 10.1016/j.ophtha.2007.03.073. Epub 2007 Jul 12.

  PMID: 17624434 BACKGROUND

• Navas A, Ariza E, Haber A, Fermon S, Velazquez R, Suarez R. Bilateral keratectasia after photorefractive keratectomy. J Refract Surg. 2007 Nov;23(9):941-3. doi: 10.3928/1081-597X-20071101-14.

  PMID: 18041251 BACKGROUND

• Guedj M, Saad A, Audureau E, Gatinel D. Photorefractive keratectomy in patients with suspected keratoconus: five-year follow-up. J Cataract Refract Surg. 2013 Jan;39(1):66-73. doi: 10.1016/j.jcrs.2012.08.058. Epub 2012 Oct 24.

  PMID: 23102727 BACKGROUND

• Koller T, Mrochen M, Seiler T. Complication and failure rates after corneal crosslinking. J Cataract Refract Surg. 2009 Aug;35(8):1358-62. doi: 10.1016/j.jcrs.2009.03.035.

  PMID: 19631120 BACKGROUND

• Abib FC, Holzchuh R, Schaefer A, Schaefer T, Godois R. The endothelial sample size analysis in corneal specular microscopy clinical examinations. Cornea. 2012 May;31(5):546-50. doi: 10.1097/ICO.0b013e3181cc7961.

  PMID: 22333658 BACKGROUND

• Kontadakis GA, Kankariya VP, Tsoulnaras K, Pallikaris AI, Plaka A, Kymionis GD. Long-Term Comparison of Simultaneous Topography-Guided Photorefractive Keratectomy Followed by Corneal Cross-linking versus Corneal Cross-linking Alone. Ophthalmology. 2016 May;123(5):974-83. doi: 10.1016/j.ophtha.2016.01.010. Epub 2016 Feb 17.

  PMID: 26896122 BACKGROUND

• Camellin M, Guidotti JM, Arba Mosquera S. Corneal-Wavefront guided transepithelial photorefractive keratectomy after corneal collagen cross linking in keratoconus. J Optom. 2017 Jan-Mar;10(1):52-62. doi: 10.1016/j.optom.2016.02.001. Epub 2016 Mar 21.

  PMID: 27012841 BACKGROUND

• Shaheen MS, Shalaby Bardan A, Pinero DP, Ezzeldin H, El-Kateb M, Helaly H, Khalifa MA. Wave Front-Guided Photorefractive Keratectomy Using a High-Resolution Aberrometer After Corneal Collagen Cross-Linking in Keratoconus. Cornea. 2016 Jul;35(7):946-53. doi: 10.1097/ICO.0000000000000888.

  PMID: 27191671 BACKGROUND

• Tomita M, Yoshida Y, Yamamoto Y, Mita M, Waring G 4th. In vivo confocal laser microscopy of morphologic changes after simultaneous LASIK and accelerated collagen crosslinking for myopia: one-year results. J Cataract Refract Surg. 2014 Jun;40(6):981-90. doi: 10.1016/j.jcrs.2013.10.044.

  PMID: 24857441 BACKGROUND

• Guell JL, Verdaguer P, Elies D, Gris O, Manero F. Persistent stromal scar after PRK and CXL: different preoperative findings, similar complication. J Refract Surg. 2015 Mar;31(3):211-2. No abstract available.

  PMID: 25870865 BACKGROUND

Study Officials

• Mauro Campos, MD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: October 25, 2016
• Study Start: January 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: October 26, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)