UnknownNot Applicable

Contribution of SA and Coma to The Total Ocular HOA Before and After FS-LASIK Using An Aspheric Ablation Profile

Egypt17 participantsStarted 2021-07-10

Plain-language summary

Laser-assisted in situ keratomileusis (LASIK) is the most frequently performed refractive surgery procedure for the correction of myopia, hyperopia, and astigmatism. There is a continuous upgrade and development in LVC surgeries correlated with the evolution of new machines and enhancement of the ablation profiles. One of the main undesirable effects of corneal refractive surgeries using conventional ablation profiles is the increase in HOAs which is associated with haloes, glare, ghost images, starburst patterns and monocular diplopia, especially in low lighting conditions and during night driving. Over the years many ablation profiles have been developed such as wavefront-guided, wavefront optimized, topography guided, Q- Value based and aspheric ablation profiles. These profiles aim to abolish LOAs and to prevent induction or increase of pre-existing HOAs aiming to improve the quality of vision experienced post-operative. In spite of the vast body of research in this area, there remains a gap in the literature investigating higher-order aberrations' components in-depth. Therefore, this study aims to investigate the contribution of spherical aberration and coma to the total higher order aberration before and after femtosecond assisted laser in situ keratomileusis using an aspheric ablation profile. This current study is a Descriptive analytical study that was conducted on 34 eyes of 17 patients who underwent corneal refractive surgery. The results were analyzed to compare the effect of FS-LASIK surgery on corneal coma and SA, and the contribution of each of them on total ocular HOAs preoperative and post-operative.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age: between 18 years and 45 years
. Myopes from -1.50 D to -8.00 D
. Astigmatism less than -4.00 D
. Normal Corneal Tomography with a Belin Ambrosio big D value of less than 1.6

Exclusion criteria

. Unstable refraction for 1 year
. Corneal thickness less than 500 microns
. Expected Post Lasik Residual Stromal bed less than 300 microns

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in percentage of contribution of coma and spherical aberration from total ocular HOA before and after FS-LASIK.

Timeframe: 6 months

Trial details

NCT IDNCT04966806

SponsorKasr El Aini Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10-15

View on ClinicalTrials.gov More FS-LASIK Surgery Effect on Higher Order Aberrations trials