Combined Corneal Wavefront-guided TPRK and ACXL Following ICRS Implantation in Management of Moderate Keratoconus

NCT04383301 | Completed

• 1 other identifier: Minia University & SFH-2
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Keratoconus leads to gradual progressive loss of vision in young and adult patients. For visual rehabilitation and to hinder keratoconus progressionthe investigators designed this study to help the keratoconus patients to improve and stabilize their vision. Design: This is a prospective consecutive uncontrolled study. Patients and Methods: This study includes 36 eyes of 36 patients with moderate degree o keratoconus (KC) undergoing combined wave front guided transepithelial photorefractive keratectomy (TPRK) and accelerated corneal collagen crosslinking (ACXL) after intracorneal ring segment (ICRS) implantation. Uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), manifest refraction spherical equivalent (MRSE), corneal indices based on Scheimpflug tomography, higher-order aberrations (HOAs) will be evaluated at baseline, after ICRS implantation, and at1, 3, 6, and 12 months after combined TPRK and CXL.

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (4)

• UDVA

  Uncorrected distance visual acuity

  one year

• CDVA

  corrected distance visual acuity

  one year

• Refractive changes

  Refractive changes in the mean sphere, mean cylinder and manifest refractive spherical equivalent (MRSE)

  one year

• Corneal Indices

  All corneal indices including steep, flat, mean and maximal keratometries

  0ne year

Secondary Outcomes (1)

• HOA and coma aberrations

  1 year

Study Arms (2)

Intra corneal ring segment

ACTIVE COMPARATOR

Intra corneal ring segment implantation for moderate keratoconus patients

Procedure: Intracorneal ring segment implantaion as the first stage

Corneal Wavefront-guided TPRK and ACXL

ACTIVE COMPARATOR

Combined Corneal Wavefront-guided Transepithelial Photorefractive Keratectomy and Accelerated Corneal Collagen Cross-linking following intracorneal ring segment by at least three months

Procedure: ACXL and wafe front guieded TPRK as the second stage

Interventions

Intracorneal ring segment implantaion as the first stage PROCEDURE

Intracorneal ring segment (ICRS)

Also known as: ICRS

Intra corneal ring segment

ACXL and wafe front guieded TPRK as the second stage PROCEDURE

Accelerated corneal cross linking (ACXL) and wafe front guided transepithelial photorefractive keratotomy (TPRK)

Also known as: ACXL and TPRK

Corneal Wavefront-guided TPRK and ACXL

Eligibility Criteria

• Age: 20 Years - 48 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patient with age \> 20 years old and intolerant to contact lense use
• patients had moderate keratoconus (45-54 D in both meridians) without corneal scarring
• Central pachymetry ≥ 400 μm and if progression had been noted over the previous 6 months.

You may not qualify if:

• Patients with central or paracentral corneal scarring
• Central pachymetry \<400 μm, systemic autoimmune disease
• History of herpetic keratitis, pregnancy, lactation, or severe dry eye syndrome.

Sponsors & Collaborators

• Shaaban Elwan: lead

Study Sites (1)

Security forces hospital

Riyadh, Central, 11481-3643, Saudi Arabia

Location

Related Publications (3)

• Al-Tuwairqi WS, Osuagwu UL, Razzouk H, Ogbuehi KC. One-Year Clinical Outcomes of a Two-Step Surgical Management for Keratoconus-Topography-Guided Photorefractive Keratectomy/Cross-Linking After Intrastromal Corneal Ring Implantation. Eye Contact Lens. 2015 Nov;41(6):359-66. doi: 10.1097/ICL.0000000000000135.

  PMID: 25839343 BACKGROUND

• Lee H, Kang DSY, Ha BJ, Choi JY, Kim EK, Seo KY, Kim TI. Visual rehabilitation in moderate keratoconus: combined corneal wavefront-guided transepithelial photorefractive keratectomy and high-fluence accelerated corneal collagen cross-linking after intracorneal ring segment implantation. BMC Ophthalmol. 2017 Dec 29;17(1):270. doi: 10.1186/s12886-017-0666-1.

  PMID: 29284455 BACKGROUND

• Koh IH, Seo KY, Park SB, Yang H, Kim I, Kim JS, Hwang DG, Nam SM. One-Year Efficacy and Safety of Combined Photorefractive Keratectomy and Accelerated Corneal Collagen Cross-Linking after Intacs SK Intracorneal Ring Segment Implantation in Moderate Keratoconus. Biomed Res Int. 2019 Jul 8;2019:7850216. doi: 10.1155/2019/7850216. eCollection 2019.

  PMID: 31360724 BACKGROUND

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Ashraf M Bakhsh, MD

  Security Forces Hospital Program

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor of ophthalmology

Model Details: Intracorneal ring segment (ICRS) followed by accelerated corneal cross linking (ACXL) and wafe front guided transepithelial photorefractive keratotomy (TPRK)

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 12, 2020
• Study Start: October 1, 2018
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: May 13, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)