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

Primary Purpose

Keratoconus

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Intracorneal ring segment implantaion as the first stage
ACXL and wafe front guieded TPRK as the second stage
Sponsored by
Shaaban Elwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus

Eligibility Criteria

20 Years - 48 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Security forces hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intra corneal ring segment

Corneal Wavefront-guided TPRK and ACXL

Arm Description

Intra corneal ring segment implantation for moderate keratoconus patients

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

Outcomes

Primary Outcome Measures

UDVA
Uncorrected distance visual acuity
CDVA
corrected distance visual acuity
Refractive changes
Refractive changes in the mean sphere, mean cylinder and manifest refractive spherical equivalent (MRSE)
Corneal Indices
All corneal indices including steep, flat, mean and maximal keratometries

Secondary Outcome Measures

HOA and coma aberrations
final root mean square (RMS) high orders aberrations (HOAs) and coma aberrations from baseline.

Full Information

First Posted
May 7, 2020
Last Updated
May 11, 2020
Sponsor
Shaaban Elwan
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1. Study Identification

Unique Protocol Identification Number
NCT04383301
Brief Title
Combined Corneal Wavefront-guided TPRK and ACXL Following ICRS Implantation in Management of Moderate Keratoconus
Official Title
Combined Corneal Wavefront-guided Transepithelial Photorefractive Keratectomy and Accelerated Corneal Collagen Cross-linking Following Intra Corneal Ring Segment Implantation in Management of Moderate Keratoconus
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shaaban Elwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Patients and Methods: This study conducted upon 36 eyes of 36 patients with moderate keratoconus who undergoing combined corneal wavefront-guided TPRK and accelerated corneal CXL at least 3 months after ICRS implantation in the period between October, 2018 and April 2020, at the Security Forces Hospital, Ophthalmology Department, Riyadh, Kingdom of Saudi Arabia. The study was approved by SFHP ethical board committee (IRB registraion number: 18-289-54) and was adhered to the tenets of the Declaration of Helsinki as well as followed good clinical practices. All patients provided informed written consent for the study and for publication. All included patients undergoing combined corneal wavefront guided TPRK and corneal ACXL at least 3 months after ICRS implantation. Grading of keratoconus was based on the Amsler Krumeich classification. Progression was defined as one or more of the following changes over a period of 6 months: an increase of ≥1.00 diopter (D) in maximal keratometry values, an increase of ≥1.00 D in manifest cylinder, and an increase of ≥ 0.50 D in MRSE. Examinations and measurements:- At baseline, the preoperative examination included UDVA, CDVA, manifest and cycloplegic refraction, slit lamp biomicroscopy, tonometry, Pentacam camera, tomography, and dilated fundus examination using binocular ophthalmoscopy. If patient use contact lenses it should be stopped 3 weeks before exam date, and medical history, including any systemic diseases, were recorded. After ICRS implantation (before combined TPRK and ACXL), and at 1, 3, 6, and 12 months after combined TPRK and CXL, all patients undergoing complete ophthalmic examinations, which included examinations for UDVA and CDVA with a Snellen chart, manifest refraction (MR). The corneal indices measured at the 8-mm zone using the Scheimpflug tomography system with Pentacam camera (OCULUS- Netzteil Art., Pentacam HR, Germany), and for measuring changes in corneal aberrations, including HOAs, coma, and spherical aberrations, corneal wavefront analysis implemented using corneal topographic data with tomography (Sirius, SCHWIND eye-tech-solutions GmbH, Kleinostheim, Germany). Root mean square (RMS) values of the corneal HOAs, with analysis up to the 7th order by expanding the set of Zernike polynomials, were calculated. Any postoperative complications, corneal haze , wound healing time were estimated. Patients overall satisfaction for the procedure were asked at last follow up and all data were recorded. Surgical technique:- First step procedure: Before the surgery, tetracaine hydrochloride 0.5% ophthalmic solution (Bausch & Lomb, Minims) and moxifloxacin 0.5% (Vigamox, Alcon Co.) drops were instilled 3 times within a 5-minutes interval. The eyelids were prepared with antiseptic Chlorohexidine Gluconate 0.05% solution (Saudi Medical Solution Company). All patients undergoing femtosecond laser enabled ICRS implantation. An Intacs SK intra-corneal ring (6.0 mm optical zone; fixed arc length of 150∘; angulation 30∘) was implanted in the cornea. The ring segment thickness sizes were decided according to the nomogram provided by the manufacturer. The incision was placed at the steepest meridian and the depth of the ring tunel was set at 75-80% of the thinnest pachymetry reading. After surgery, a bandage contact lens (BIOMEDICS Evolution CL ocufilcon D 45%, water 55%) was placed to be removed after incision healing. Postoperative use of moxifloxacin 0.5% (Vigamox, Alcon Co.) eye drops 4 times/ day for two weeks, tobradex eye drops (Tobramycin 0.3%- dexamethasone 0.1%, Alcon Co.) with tapering dose for 1 month, and sodium hyaluronate 0.2% ( Hyfresh eye drops, Jamjoom Pharma Co.) eye drops QID for 3 months. Second step procedure: After at least 3 months with average 3.9 ± 2.2 and range (3-5) months from the ICRS implantation and when the mean keratometry stabilized and not decreased > 1 diopter from the previous visit, all patients were scheduled for combined corneal wavefront-guided TPRK and accelerated CXL. TPRK between the corneal ring segments were performed using Amaris excimer LASER 193 nm, version 750 S (Schwind eye-tech-solutions GmbH& Co. KG, Mainparkstrasse, Kleinostheim, Germany. The ablation profile was planned using the integrated Optimized Refractive Keratectomy-Custom Ablation Manager software (Schwind eye-tech-solutions GmbH and Co KG). Using this software, ablation was planned based on clinical parameters, including manifest refraction, pachymetry, and corneal wavefront data (up to the 7th order aberrations) and topography obtained with the Sirius topographer. The maximum ablation depth was limited to ( 50- 60 micro m), and then mitomycin C 0.02% (MMC) was applied for 20 seconds to reduce postoperative haze followed by eye irrigation with balanced saline solution (BSS). Riboflavin 0.1 % with hydroxypropyl methylcellulose (Vibex Rapid; Avedro Inc., Waltham, MA, USA) is soaked onto the corneal surface for 10 minutes immediately after excimer laser ablation. Riboflavin solution were added at 2 minutes interval during the soaking process after which the eye was irrigated with cold BSS. After completion of soaking, Ultra viollet A exposure (wavelength: 365 nm) was performed for 10 minutes at an irradiance of 9 mW/cm², to give a total radiant exposure of 5.4 J/cm² and intermittent riboflavin drops application during radiant exposure. At the end of the surgery a bandage contact lens was placed, and the same previous postoperative medications were used beside pain keller oral tablet was perscribed if needed. Statistical Analysis:- The investigators recorded all patients' data in Microsoft Excel Sheet, then copied and analyzed using A Graph Pad Prism 8 program; Paired student's t-test was used for the UDVA & CDVA means in log MAR values and for MRSE means. One way ANOVA was used for corneal indices. For all tests, a (P value < 0.05) was considered statistically significant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Intracorneal ring segment (ICRS) followed by accelerated corneal cross linking (ACXL) and wafe front guided transepithelial photorefractive keratotomy (TPRK)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intra corneal ring segment
Arm Type
Active Comparator
Arm Description
Intra corneal ring segment implantation for moderate keratoconus patients
Arm Title
Corneal Wavefront-guided TPRK and ACXL
Arm Type
Active Comparator
Arm Description
Combined Corneal Wavefront-guided Transepithelial Photorefractive Keratectomy and Accelerated Corneal Collagen Cross-linking following intracorneal ring segment by at least three months
Intervention Type
Procedure
Intervention Name(s)
Intracorneal ring segment implantaion as the first stage
Other Intervention Name(s)
ICRS
Intervention Description
Intracorneal ring segment (ICRS)
Intervention Type
Procedure
Intervention Name(s)
ACXL and wafe front guieded TPRK as the second stage
Other Intervention Name(s)
ACXL and TPRK
Intervention Description
Accelerated corneal cross linking (ACXL) and wafe front guided transepithelial photorefractive keratotomy (TPRK)
Primary Outcome Measure Information:
Title
UDVA
Description
Uncorrected distance visual acuity
Time Frame
one year
Title
CDVA
Description
corrected distance visual acuity
Time Frame
one year
Title
Refractive changes
Description
Refractive changes in the mean sphere, mean cylinder and manifest refractive spherical equivalent (MRSE)
Time Frame
one year
Title
Corneal Indices
Description
All corneal indices including steep, flat, mean and maximal keratometries
Time Frame
0ne year
Secondary Outcome Measure Information:
Title
HOA and coma aberrations
Description
final root mean square (RMS) high orders aberrations (HOAs) and coma aberrations from baseline.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashraf M Bakhsh, MD
Organizational Affiliation
Security Forces Hospital Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
Security forces hospital
City
Riyadh
State/Province
Central
ZIP/Postal Code
11481-3643
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25839343
Citation
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.
Results Reference
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PubMed Identifier
29284455
Citation
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.
Results Reference
background
PubMed Identifier
31360724
Citation
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.
Results Reference
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Combined Corneal Wavefront-guided TPRK and ACXL Following ICRS Implantation in Management of Moderate Keratoconus

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