NCT03708575

Brief Summary

Ectasia after refractive surgery is a relatively rare complication which can lead to sight-threatening complications if not detected and treated in time. It is important to continue our quest to improve our methods of identifying absolute and relative risk factors of ectasia following various keratorefractive surgical procedures.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

December 10, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2020

Completed
Last Updated

October 17, 2018

Status Verified

October 1, 2018

Enrollment Period

1 year

First QC Date

October 10, 2018

Last Update Submit

October 13, 2018

Conditions

Corneal Ectasia

Outcome Measures

Primary Outcomes (1)

  • Post-LASIK Ectasia

    Evaluating back elevation of cornea (in numbers) , corneal curvature (in diopters) , and curvature map (in diopters) using Pentacam oculizer

    5 minutes

Secondary Outcomes (1)

  • Absolute and relative risk factors of ectasia and their cut-off values.

    5 minutes

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients presented with post-LASIK corneal ectasia

You may qualify if:

  • All subjects presented with ectasia following LASIK

You may not qualify if:

  • Any associated ocular pathology.
  • Any previous ocular surgeries other than LASIK.
  • Corneal opacities.
  • Ocular trauma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • Vestergaard AH. Past and present of corneal refractive surgery: a retrospective study of long-term results after photorefractive keratectomy and a prospective study of refractive lenticule extraction. Acta Ophthalmol. 2014 Mar;92 Thesis 2:1-21. doi: 10.1111/aos.12385.

    PMID: 24636364BACKGROUND

  • Pallikaris IG, Papatzanaki ME, Siganos DS, Tsilimbaris MK. A corneal flap technique for laser in situ keratomileusis. Human studies. Arch Ophthalmol. 1991 Dec;109(12):1699-702. doi: 10.1001/archopht.1991.01080120083031.

    PMID: 1841579BACKGROUND

  • Pallikaris IG, Papatzanaki ME, Stathi EZ, Frenschock O, Georgiadis A. Laser in situ keratomileusis. Lasers Surg Med. 1990;10(5):463-8. doi: 10.1002/lsm.1900100511.

    PMID: 2233101BACKGROUND

  • Deitz MR, Sanders DR, Raanan MG, DeLuca M. Long-term (5- to 12-year) follow-up of metal-blade radial keratotomy procedures. Arch Ophthalmol. 1994 May;112(5):614-20. doi: 10.1001/archopht.1994.01090170058022.

    PMID: 8185517BACKGROUND

  • dos Santos AM, Torricelli AA, Marino GK, Garcia R, Netto MV, Bechara SJ, Wilson SE. Femtosecond Laser-Assisted LASIK Flap Complications. J Refract Surg. 2016 Jan;32(1):52-9. doi: 10.3928/1081597X-20151119-01.

    PMID: 26812715BACKGROUND

  • Sridhar MS, Rao SK, Vajpayee RB, Aasuri MK, Hannush S, Sinha R. Complications of laser-in-situ-keratomileusis. Indian J Ophthalmol. 2002 Dec;50(4):265-82.

    PMID: 12532491BACKGROUND

  • Santhiago MR, Giacomin NT, Smadja D, Bechara SJ. Ectasia risk factors in refractive surgery. Clin Ophthalmol. 2016 Apr 20;10:713-20. doi: 10.2147/OPTH.S51313. eCollection 2016.

    PMID: 27143849BACKGROUND

  • Randleman JB. Evaluating risk factors for ectasia: what is the goal of assessing risk? J Refract Surg. 2010 Apr;26(4):236-7. doi: 10.3928/1081597X-20100318-02. No abstract available.

    PMID: 20415319BACKGROUND

  • 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: 17624434BACKGROUND

  • Chang AW, Tsang AC, Contreras JE, Huynh PD, Calvano CJ, Crnic-Rein TC, Thall EH. Corneal tissue ablation depth and the Munnerlyn formula. J Cataract Refract Surg. 2003 Jun;29(6):1204-10. doi: 10.1016/s0886-3350(02)01918-1.

    PMID: 12842691BACKGROUND

  • Randleman JB, Russell B, Ward MA, Thompson KP, Stulting RD. Risk factors and prognosis for corneal ectasia after LASIK. Ophthalmology. 2003 Feb;110(2):267-75. doi: 10.1016/S0161-6420(02)01727-X.

    PMID: 12578766BACKGROUND

  • Haw WW, Manche EE. Iatrogenic keratectasia after a deep primary keratotomy during laser in situ keratomileusis. Am J Ophthalmol. 2001 Dec;132(6):920-1. doi: 10.1016/s0002-9394(01)01148-5.

    PMID: 11730659BACKGROUND

  • Giri P, Azar DT. Risk profiles of ectasia after keratorefractive surgery. Curr Opin Ophthalmol. 2017 Jul;28(4):337-342. doi: 10.1097/ICU.0000000000000383.

    PMID: 28594648BACKGROUND

Study Officials

  • Khaled A. Mohamed, Lecturer

    Assiut University

    STUDY CHAIR

Central Study Contacts

Gamal N. Mahmoud, Professor

CONTACT

01223211939gamalnouby@live.com

Ahmed Mahmoud F. Fathalla, Assist prof.

CONTACT

01223971401ahmedfathalla@yahoo.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal Investigator

Study Record Dates

First Submitted

October 10, 2018

First Posted

October 17, 2018

Study Start

December 10, 2018

Primary Completion

December 10, 2019

Study Completion

August 10, 2020

Last Updated

October 17, 2018

Record last verified: 2018-10