Hyperopic LASIK With Crosslinking Versus Standard LASIK

NCT03224013 | Completed

• 1 other identifier: Hyperopic LASIK
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

Analysis corneal and refractive stability of hyperopic laser-assisted in situ keratomileusis (LASIK) with and without concurrent prophylactic high-fluence cross-linking (CXL).

Conditions

Hyperopia

Outcome Measures

Primary Outcomes (1)

• assessment of changes in refractive spherical equivalent

  assessment of changes in manifest refraction by autorefractometer and then calculate spherical equivalent

  preoperative and 3 months and 6 months postoperative

Study Arms (2)

Hyperopic LASIK with crosslinking

ACTIVE COMPARATOR

group 1:hyperopic customized LASIK with concurrent prophylactic high-fluence cross-linking

Procedure: LASIK

Hyperopic LASIK only

ACTIVE COMPARATOR

group 2: hyperopic customized LASIK only

Procedure: LASIK

Interventions

LASIK PROCEDURE

LASIK with concurrent prophylactic high fluence crosslinking in right eye ( After the excimer laser ablation, and with the flap folded onto itself and protected with a dry sponge, one drop of Vibex Rapid™ , consisting of 0.10% saline-diluted riboflavin (a very slightly hypotonic solution, mixed with hydroxypropyl methylcellulose, a dextran substitute), was placed on the exposed stromal bed afforded by the open LASIK flap and carefully spread over the bed area with an irrigating cannula for 60 seconds and LASIK only in left eye

Hyperopic LASIK only; Hyperopic LASIK with crosslinking

Eligibility Criteria

• Age: 18 Years - 61 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Cases with hyperopia +1diopter to +6 diopters or hyperopic astigmatism up to 4 diopters

You may not qualify if:

• Patients with previous intraocular or corneal surgery, active corneal disease

Sponsors & Collaborators

• Minia University: lead

MeSH Terms

Conditions

Hyperopia

Interventions

Keratomileusis, Laser In Situ

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Corneal Surgery, Laser; Laser Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Keratectomy; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures

Study Officials

• Jorge L Alio, MD

  MD, Phd, FEBO

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Ophthalmology.Faculty of Medicine

Model Details: Interventional prospective consecutive comparative case control series of cases; 50 eyes of 25 patients with mean age 35.7 ± 12.4 (Range 18-61years) with hyperopia or hyperopic astigmatism underwent customized LASIK with concurrent prophylactic high-fluence cross-linking in right eye (group 1) and customized LASIK only in left eye (group 2). Cases with hyperopia +1D to +6D or hyperopic astigmatism up to 4D were included in the study. Patients with previous intraocular or corneal surgery, active corneal disease were excluded from the study. Main outcome measures were uncorrected visual acuity (UCVA), manifest refractive spherical equivalent (MRSE), cycloplegic refractive spherical equivalent (CRSE), keratometric measurments and spherical aberrations at 4 mm and maximum pupilnand their ecolution along 6 months postoperatively.

Study Record Dates

• First Submitted: July 15, 2017
• First Posted: July 21, 2017
• Study Start: January 18, 2016
• Primary Completion: May 12, 2017
• Study Completion: July 12, 2017
• Last Updated: July 21, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share