Surgical Procedure, UnspecifiedNCT02943967

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

A study testing CXL + PRK group and PRK group in people with Surgical Procedure, Unspecified, 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

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 23 to 51 yearsHealthy volunteers can take part
Conditions the study is for: Surgical Procedure, Unspecified
What is being tested?: CXL + PRK group and PRK group
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteBrazil
Study dates: Jan 2010to Jan 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 23 to 51 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Federal University of São Paulo
São Paulo, São Paulo, 04023-062

Other trials in Brazil

About this study

Official title: Two Years Follow up of Corneal Cor Cross-linking and Refractive Surface Ablation in Patients With Asymmetric Corneal Topography

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.

Read the detailed description

Corneal cross-linking (CXL) by the photosensitizer, riboflavin (vitamin B2), and ultraviolet A (UVA) light increases corneal rigidity and has been described as an effective method for stabilizing the cornea in patients with progressive keratoconus. The photochemical reaction in this procedure causes the collagen to form additional covalent connections between its fibers, which stabilizes the stromal collagen fibers, improving the collagen's structure and the cornea rigidity. It is a relatively safe procedure with low rates of complications Photorefractive keratectomy (PRK) it is a traditional technique for refractive surgery. In cases of irregular corneas or re-operation normally the favorite ablation profile chosen is the guided surgery, topography guided or wavefront guided, showing better results. This technique is also relatively safe procedure with low rates of complications. One of the most unwanted complications of this surgery and also rare is corneal ectasia.

Combining PRK and CXL is already done in patients with keratoconus and suspected keratoconus.

This combined procedure uses the principle that CXL stiffen the cornea making it possible to reduce corneal thickness with PRK without weakening corneal strength. Literature show better results, in keratoconus, with simultaneous procedures. Guedj et al performed PRK in keratoconus suspects and within 5 years he did not found any corneal ectasia.

Conditions: Surgical Procedure, Unspecified
Being tested: CXL + PRK group, PRK group
Keywords: Refractive Surgical Procedures, Photorefractive Keratectomy, Aberrometry

What participants receive

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

CXL + PRK groupProcedure or surgery
Corneal cross-linking with subsequent photorefractive keratotomy after 6 months was performed in one eye
PRK groupProcedure or surgery
Photorefractive keratotomy alone was performed in contra lateral eyes

Study groups in NCT02943967
Study group	Role	What they receive
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 Receives: 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 Receives: Procedure: PRK group

What is being measured

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

Refractive results - spherical equivalent in diopters
Measured: 30 months

Secondary outcomes (5)

Biomicroscopy findings with the slit lamp
Measured: 30 months
Visual acuity in logMar
Measured: 30 months
Aberrometric Results in root mean square
Only coma and spherical aberration
Measured: 18 months
Topographic results in diopters
we will measure the increase in diopters with time
Measured: 30 months
Pachymetric results in micra
Measured: 30 months

Timeline

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

Jan 2010Jan 2014

First posted25 Oct 2016 (estimated)
Study startJan 2010
Primary completionJan 2014
Study completionJan 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Surgical Procedure, UnspecifiedStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02943967
Sponsor's protocol ID: 2088/88
Status last verified: Oct 2016
First submitted: 21 Oct 2016
Last updated: 26 Oct 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: Yes

Publications

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.
PubMed 22569468
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.
PubMed 25532633
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.
PubMed 12498842
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.
PubMed 17624434
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.
PubMed 18041251
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.
PubMed 23102727
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.
PubMed 19631120
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.
PubMed 22333658
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.
PubMed 26896122
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.
PubMed 27012841
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.
PubMed 27191671
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.
PubMed 24857441
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.
PubMed 25870865

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Two Years Follow up of Corneal Cor Cross-linking and Refractive Surface Ablation in Patients With Asymmetric Corneal Topography
ClinicalTrials.gov ID: NCT02943967
Acronym / sponsor ID: 2088/88
Conditions: Surgical Procedure, Unspecified
Keywords: Refractive Surgical Procedures, Photorefractive Keratectomy, Aberrometry
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Federal University of São PauloUniversity, hospital or other
Study start: Jan 2010
Primary completion: Jan 2014 (actual)
Study completion: Jan 2014 (actual)
First posted: 25 Oct 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Combining PRK and CXL is already done in patients with keratoconus and suspected keratoconus.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
CXL + PRK group	Active comparator	Procedure: CXL + PRK groupCorneal 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
PRK group	Active comparator	Procedure: PRK groupPhotorefractive 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

Who may qualify

Ages: 23 to 51 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CXL + PRK groupCorneal cross-linking with subsequent photorefractive keratotomy after 6 months was performed in one eye	Procedure or surgery	CXL + PRK group
PRK groupPhotorefractive keratotomy alone was performed in contra lateral eyes	Procedure or surgery	PRK group

Primary outcome

Refractive results - spherical equivalent in diopters
Time frame: 30 months

5 secondary outcomes

Biomicroscopy findings with the slit lamp
Time frame: 30 months
Visual acuity in logMar
Time frame: 30 months
Aberrometric Results in root mean square
Time frame: 18 months
Topographic results in diopters
Time frame: 30 months
Pachymetric results in micra
Time frame: 30 months

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
Background: PubMed 22569468Cheema 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.
Background: PubMed 25532633Raiskup 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.
Background: PubMed 12498842Carones 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.
Background: PubMed 17624434Randleman 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.
Background: PubMed 18041251Navas 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.
Background: PubMed 23102727Guedj 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.
Background: PubMed 19631120Koller 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.
Background: PubMed 22333658Abib 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.
Background: PubMed 26896122Kontadakis 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.
Background: PubMed 27012841Camellin 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.
Background: PubMed 27191671Shaheen 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.
Background: PubMed 24857441Tomita 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.
Individual participant dataSharing planned: Yes

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mauro Campos, MD principal investigator

Federal University of São Paulo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CXL + PRK group and PRK group in people with Surgical Procedure, Unspecified, 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 4 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 26 Oct 2016. 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?

Refractive results - spherical equivalent in diopters (time frame: 30 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 NCT02943967, which also lists 13 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 26 Oct 2016.