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Refractive Surgery clinical trials

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NCT ID: NCT05406973 Completed - Refractive Surgery Clinical Trials

Comparison Between the SBK Microkeratome Versus Femtosecond Laser in Flap Creation During LASIK Surgery for Myopia

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

LASIK is the most commonly performed refractive surgery worldwide. It has been shown to be safe and effective procedure with predictable results over long term follow ups. With the advancement of technology, sub-Bowman keratomileusis allows thin flap of approximately 100 microns thickness thus preserving thicker stromal bed as compared to conventional LASIK. The femtosecond laser corneal flap has th advantage of producing a flap of uniform thickness, adjustable flap diameter, relatively few complications. The disadvantages of this procedure is the high cost of surgery, development of bubbles in the corneal layer and anterior chamber which may affect pupil trackingduring the procedure. Despite the emergence of femtosecond laser-assisted flap creation, mechanical microkeratomes remain the preferred choice in the majority of developing countries. Recent studies have shown that SBK corneal flap has the same advantages as femtosecond laser flap regarding flap uniformity, regularity, and accuracy with less suction time and cost, but with its specific complications as well.

NCT ID: NCT05060094 Completed - Refractive Surgery Clinical Trials

Comparison of Outcomes Between TransPRK and Off-flap Epi-LASIK

Start date: March 1, 2016
Phase:
Study type: Observational

To compare the quantitative and qualitative optical outcomes between single-step transepithelial photorefractive keratectomy (TransPRK) and off-flap epipolis laser in situ keratomileusis (Epi-LASIK) in moderate to high myopia.we included patients with moderate to high myopia who were randomized to have TransPRK in one eye and Epi-LASIK in the other eye. All patients underwent comprehensive ophthalmological examinations, including uncorrected (UDVA) and corrected distance visual acuities (CDVA), manifest refraction, intraocular pressure, anterior and posterior segment examination, corneal topography measured by Scheimpflug scanning-slit topographer (Pentacam, Oculus Optikgerate GmbH), contrast sensitivity (CS) under photopic and mesopic conditions (CSV-1000E, Vector Vision Inc., Greenville, OH, USA) with correction by spectacles, ocular wavefront aberrometry (OPD-Scan II, Nidek Co. Ltd). At each follow-up, CS and aberration measures were repeated 3 times and the average value was analyzed. Optical parameters were repeated 1, 3, 6, and 12 months after surgery.Statistical analysis was performed using SPSS software (version 22.0, SPSS, Chicago, Inc.). Kolmogorov-Smirnov test was used to check the normal distribution of variables. Student t-test or Wilcoxon rank sum test was used based on the normality of data. A P value less than 0.05 was considered statistically significant.

NCT ID: NCT04899258 Completed - Cornea Clinical Trials

Evaluation of the Effect of Myopic Femtosecond Laser Assisted-LASIK on Anterior Chamber Flare Values and Corneal Endothelial Cells: A Prospective Before-and-After Study

Start date: December 12, 2019
Phase: N/A
Study type: Interventional

This study aimed to investigate whether femtosecond laser-assisted LASIK (FS-LASIK) surgery causes inflammation in the anterior chamber and to analyze its effect on endothelial cells.

NCT ID: NCT04684888 Completed - Refractive Errors Clinical Trials

Femto-flap Versus SBK Flap,Predictability and Variability

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Laser Insitu keratomileusis (LASIK) has become the most popular procedure for refractive error correction. Lasik flap creation is the first and critical step during LASIK surgery because of its consensual effect on a residual stromal bed, corneal biomechanics, and hence the future risk of ectasia⁴.In the current study, we compared the Visumax FSL flap thickness predictability, accuracy, and variability with the flap created by single-use Moria SBK microkeratome.

NCT ID: NCT04396990 Completed - Refractive Surgery Clinical Trials

The RESTORE Study, A Randomized, Controlled, Masked (Reading Center) Prospective Study

Start date: June 8, 2020
Phase:
Study type: Observational

To determine patient preference and treatment outcomes with an intracanalicular dexamethasone (0.4mg) insert compared to standard steroid drop regimen in the contralateral eye following bilateral PRK surgery.

NCT ID: NCT03938883 Completed - Refractive Surgery Clinical Trials

Ocular Bandage Gel (OBG) Pivotal Trial in Patients Undergoing Photorefractive Keratectomy ("PRK")

Start date: June 25, 2019
Phase: N/A
Study type: Interventional

Prospective, randomized, masked (reading center), controlled pivotal study of Ocular Bandage Gel (OBG) vs. a bandage contact lens (BCL) in subjects who have undergone bilateral photorefractive keratectomy (PRK).

NCT ID: NCT03791684 Completed - Refractive Surgery Clinical Trials

Accelerated Versus Standard CXL in the Treatment of Ectasia Post Refractive Surgery and Penetrating Keratoplasty.

Start date: January 16, 2016
Phase: N/A
Study type: Interventional

WHAT WAS KNOWN *Standard CXL is the common procedure for treating progressive corneal ectasia. Modifications of the standard protocol were introduces to reduce its complications especially long exposure to ultraviolet rays. The Accelerated protocol, while believed to overcome this issue with comparable outcomes, has not been studied fully in patients with ectasia following corneal refractive surgery and penetrating keratoplasty. WHAT THIS PAPER ADDS Accelerated CXL is as safe and effective as the Standard CXL in halting the progression of ectasia post refractive surgery and penetrating keratoplasty with the benefit of: reduced ultraviolet exposure, reduced operation time, and reduced patient discomfort.

NCT ID: NCT03597906 Completed - Refractive Surgery Clinical Trials

Topography Guided LASIK by Different Protocols for Treatment of Astigmatism

Start date: August 15, 2018
Phase: N/A
Study type: Interventional

Background and Rationale: LASIK has been among the highest satisfaction rates of surgical procedures, ranging from 82%-98%. Different ablation profiles have been developed over the years. The purpose of this study is to validate this novel measurement by comparing the visual outcomes when the TMR is used in myopic astigmatic LASIK to using the standard manifest refraction or the Topolyzer measurements alone. Objectives : To evaluate the safety, efficacy and predictability of topography-guided myopic LASIK with three different refraction treatment strategies.

NCT ID: NCT03569423 Completed - Myopia Clinical Trials

Comparison Between TPRK Versus AAPRK in Correction of Myopia

Start date: February 15, 2017
Phase: N/A
Study type: Interventional

PURPOSE: The aim of the study is to compare visual acuity means, refractive results, safety, and efficacy of TPRK with AAPRK as primary outcomes and surgical time, pain scores, haze levels, and healing time as secondary outcomes. SETTING: Security Forces Hospital, Ophthalmology Department, Riyadh, Kingdom of Saudi Arabia. DESIGN: Prospective, consecutive, nonrandomized case-control comparative study. . METHODS: A total of 200 eyes of 100 patients were included. One hundred eyes underwent TPRK in the right eye (study group) and 100 eyes underwent AAPRK in the left eye (control group). Ablations performed with the Schwind Amaris, 750S. Clinical outcomes were compared Paired student's t-tests and Mann-Whitney tests were used for statistical analysis.

NCT ID: NCT00742950 Completed - Cataract Clinical Trials

Refractive Change Induced by 2.8-mm Corneal Incision

CINPHA
Start date: August 2008
Phase: N/A
Study type: Interventional

The investigators' purpose is to study the induced refractive change caused by different 2.8-mm corneal incision locations in phacoemulsification, because the investigators hypothesize that the effect may be different for nasal, temporal, and superior location, although they are considered astigmatism neutral. Patients will be randomized to nasal or temporal incision, or assigned to superior incision, depending on preexisting astigmatism. Visual acuity, refraction, keratometry, Pentacam analysis, intraocular pressure, biomicroscopy, and funduscopy, will be carried out before and after phacoemulsification. Outcome measures will be induced corneal refractive change (Fourier power vector analysis), ISV change, and visual acuity, at 6 months.