Corneal EctasiaNCT03708575
Evaluating Risk Factors of Post-LASIK Ectasia
An observational study of Corneal Ectasia, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Corneal Ectasia
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2018to 10 Aug 2020
- Phase
- Observational
- 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 18 to 45 years
- All sexes
- Adult
Study population: patients presented with post-LASIK corneal ectasia
Who may be able to join
- All subjects presented with ectasia following LASIK
Who cannot join
- Any associated ocular pathology.
- Any previous ocular surgeries other than LASIK.
- Corneal opacities.
- Ocular trauma.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Risk Assessment for Corneal Ectasia Following Laser in Situ Keratomileusis
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.
Read the detailed description
Surgical correction of refractive errors is becoming increasingly popular. In the 1990s, the excimer laser revolutionized the field of corneal refractive surgery with PRK and LASIK, refractive lenticule extraction (ReLEx) of intracorneal tissue using only a femtosecond laser, and lately ReLEx smile (SMILE). The term LASIK (Laser in situ keratomileusis) was first used in 1990 by Pallikaris, in which a microkeratome was used to cut a hinged corneal flap, followed by excimer ablation of the stromal bed and flap repositioning . LASIK is known to be a safe refractive surgical procedure, with good refractive efficacy and predictability and is associated with rapid visual recovery with minimal risk of complications.
Most of complications are flap related and include a free cap, a button hole, an incomplete cut, flap striae, interface debris, diffuse lamellar keratitis (DLK), and epithelial ingrowth. Other complications include undercorrection, overcorrection, decentered ablation, irregular ablation, and ectasia.
Corneal ectasia is a sight-threatening complication of laser refractive surgery characterized by progressive steepening and thinning of the cornea.It is defined as progressive stromal thinning and steepening of the cornea, resulting in refractive aberrations and visual deterioration. The incidence of post- LASIK ectasia is estimated to be between 0.04% and 0.6%.Corneal ectasia has been observed to occur as early as 1 week and as late as several years after LASIK.
The main purpose of assessing risk is to determine what group or groups of people present a higher chance to develop post-LASIK ectasia. The development of postoperative ectasia varies between LASIK centers and depends on the screening tools used to screen candidates, the experience and technical skill of the surgeon, and the tools used during the surgery. Risk factors for the development of post-LASIK ectasia include young age, a personal or family history of keratoconus, forme fruste keratoconus (FFKC), high myopia, low-residual stromal bed (RSB), and deep primary keratotomy resulting in a thick flap.
Although several risk factors have been identified for the likelihood of ectasia development after keratorefractive surgeries, some cases have been reported to develop in an enigmatic way, without the prescence of any of these risk factors.
- Conditions
- Corneal Ectasia
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-LASIK Ectasia
Evaluating back elevation of cornea (in numbers) , corneal curvature (in diopters) , and curvature map (in diopters) using Pentacam oculizer
Measured: 5 minutes
Secondary outcomes (1)
Absolute and relative risk factors of ectasia and their cut-off values.
Degree of refraction error (in diopters) using Autorefractometer , corneal pachymetry (in micrometers) , residual stromal bed (in micrometers) , flap thickness (in micrometers) , ablation depth (in micrometers) using Pentacam oculizer , and time between LASIK and diagnosis of ectasia (in days)
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start10 Dec 2018 (estimated)
- Primary completion10 Dec 2019 (estimated)
- Study completion10 Aug 2020 (estimated)
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 Corneal EctasiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HMTAbdelmoniem, Assiut University
- Investigators
- Khaled A. Mohamed, Lecturer, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708575
- Sponsor's protocol ID
- RFinCE
- Status last verified
- Oct 2018
- First submitted
- 10 Oct 2018
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24636364Pallikaris 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.
PubMed 1841579Pallikaris 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.
PubMed 2233101Deitz 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.
PubMed 8185517dos 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.
PubMed 26812715Sridhar 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.
PubMed 12532491Santhiago 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.
PubMed 27143849Randleman 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.
PubMed 20415319Randleman 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 17624434Chang 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.
PubMed 12842691Randleman 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.
PubMed 12578766Haw 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.
PubMed 11730659Giri P, Azar DT. Risk profiles of ectasia after keratorefractive surgery. Curr Opin Ophthalmol. 2017 Jul;28(4):337-342. doi: 10.1097/ICU.0000000000000383.
PubMed 28594648
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Assessment for Corneal Ectasia Following Laser in Situ Keratomileusis
- ClinicalTrials.gov ID
- NCT03708575
- Acronym / sponsor ID
- RFinCE
- Conditions
- Corneal Ectasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Dec 2018 (estimated)
- Primary completion
- 10 Dec 2019 (estimated)
- Study completion
- 10 Aug 2020 (estimated)
- First posted
- 17 Oct 2018 (actual)
- 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.
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.
Detailed description
Surgical correction of refractive errors is becoming increasingly popular. In the 1990s, the excimer laser revolutionized the field of corneal refractive surgery with PRK and LASIK, refractive lenticule extraction (ReLEx) of intracorneal tissue using only a femtosecond laser, and lately ReLEx smile (SMILE). The term LASIK (Laser in situ keratomileusis) was first used in 1990 by Pallikaris, in which a microkeratome was used to cut a hinged corneal flap, followed by excimer ablation of the stromal bed and flap repositioning . LASIK is known to be a safe refractive surgical procedure, with good refractive efficacy and predictability and is associated with rapid visual recovery with minimal risk of complications.
Most of complications are flap related and include a free cap, a button hole, an incomplete cut, flap striae, interface debris, diffuse lamellar keratitis (DLK), and epithelial ingrowth. Other complications include undercorrection, overcorrection, decentered ablation, irregular ablation, and ectasia.
Corneal ectasia is a sight-threatening complication of laser refractive surgery characterized by progressive steepening and thinning of the cornea.It is defined as progressive stromal thinning and steepening of the cornea, resulting in refractive aberrations and visual deterioration. The incidence of post- LASIK ectasia is estimated to be between 0.04% and 0.6%.Corneal ectasia has been observed to occur as early as 1 week and as late as several years after LASIK.
The main purpose of assessing risk is to determine what group or groups of people present a higher chance to develop post-LASIK ectasia. The development of postoperative ectasia varies between LASIK centers and depends on the screening tools used to screen candidates, the experience and technical skill of the surgeon, and the tools used during the surgery. Risk factors for the development of post-LASIK ectasia include young age, a personal or family history of keratoconus, forme fruste keratoconus (FFKC), high myopia, low-residual stromal bed (RSB), and deep primary keratotomy resulting in a thick flap.
Although several risk factors have been identified for the likelihood of ectasia development after keratorefractive surgeries, some cases have been reported to develop in an enigmatic way, without the prescence of any of these risk factors.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Age groups
- Adult
- Study population
- patients presented with post-LASIK corneal ectasia
Key inclusion criteria (1 listed)
- All subjects presented with ectasia following LASIK
Key exclusion criteria (4 listed)
- Any associated ocular pathology.
- Any previous ocular surgeries other than LASIK.
- Corneal opacities.
- Ocular trauma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post-LASIK Ectasia
Time frame: 5 minutes
Evaluating back elevation of cornea (in numbers) , corneal curvature (in diopters) , and curvature map (in diopters) using Pentacam oculizer
1 secondary outcome
Absolute and relative risk factors of ectasia and their cut-off values.
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Background: PubMed 24636364Vestergaard 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.
- Background: PubMed 1841579Pallikaris 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.
- Background: PubMed 2233101Pallikaris 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.
- Background: PubMed 8185517Deitz 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.
- Background: PubMed 26812715dos 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.
- Background: PubMed 12532491Sridhar 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.
- Background: PubMed 27143849Santhiago 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.
- Background: PubMed 20415319Randleman 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.
- 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 12842691Chang 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.
- Background: PubMed 12578766Randleman 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.
- Background: PubMed 11730659Haw 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.
Related trials for Corneal Ectasia
RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Keratoconus, Ectasia
RecruitingPhase 2/3
Corneal Crosslinking for Treatment of Progressive Keratoconus or Corneal Ectasia
Keratoconus, Corneal Ectasia
RecruitingObservational study
Corneal Elastography and Patient Specific Modeling
Cornea; Ectasia, Refractive Errors
Not yet recruitingPhase 4
Outcomes of CTAK Surgery
Keratoconus, Corneal Ectasia
RecruitingPhase 3
Comparison of Epi-ON Corneal Collagen Crosslinking Performed Using an 18-Minute UVA Exposure vs. a 24-Minute UVA Exposure on Eyes With Ectatic Corneal Diseases
Keratoconus, Ectasia of Cornea
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.
Khaled A. Mohamed, Lecturer study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Ectasia, run by Assiut University.
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 1 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: status not confirmed, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gamal N. Mahmoud, Professor (01223211939, gamalnouby@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-LASIK Ectasia (time frame: 5 minutes). 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 NCT03708575, 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 17 Oct 2018.