Effect of Intracorneal Ring Segments on Posterior Corneal Tomography in Eyes With Keratoconus

Keratoconus Clinical Trial

Official title:

Effect of Intracorneal Ring Segments on Posterior Corneal Tomography in Eyes With Keratoconus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04748198
• Other study ID #: FMASU MD 140/2018
• Status: Completed
• Phase: N/A
• Start date: June 10, 2018
• Est. completion date: June 15, 2020

Study information

• Verified date: February 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Our purpose is to analyze the changes induced in the posterior corneal surface in patients implanted with intracorneal ring segments for treatment of keratoconus. Patients are assessed with corneal imaging device preoperatively and at 1, 3, 6 and 12 months postoperatively.

Description:

Procedure: Femtosecond laser assisted implantation of intracorneal ring segments in keratoconus patients Uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA), refraction, keratometric (K) readings of the anterior and posterior surface, corneal asphericity (Q value) of the anterior and posterior surface, and anterior and posterior elevations are evaluated using a corneal imaging device preoperatively and at 1, 3, 6 and 12 months after surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 15, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria

• Patients with keratoconus grade 1, 2 or 3 according to Amsler-Krumeich classification.

• Best corrected visual acuity (BCVA) = 6/12.

• Mean front keratometric (K) readings = 60 diopters (D).

• Corneal thickness = 400 µm at the location of ICRS implantation.

• Clear central cornea

Exclusion Criteria

• Central corneal opacity.

• Previous corneal laser refractive surgery.

• Previous corneal collagen cross linking.

• Previous cataract surgery or phakic IOL implantation.

• History of herpetic keratitis.

• History of acute hydrops.

• Ocular comorbidities such as cataract, glaucoma or retinal disease.

• Systemic diseases affecting healing process such as autoimmune or connective tissue disease.

Related Conditions & MeSH terms

• Keratoconus
• Keratoconus Posterior

Intervention

Procedure:
• Intracorneal ring segment implantation
Surgical procedure for keratoconus treatment. A tunnel is created in the corneal stroma with femtosecond laser and ring segments are implanted in the corneal stroma

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Muftuoglu O, Aydin R, Kilic Muftuoglu I. Persistence of the Cone on the Posterior Corneal Surface Affecting Corneal Aberration Changes After Intracorneal Ring Segment Implantation in Patients With Keratoconus. Cornea. 2018 Mar;37(3):347-353. doi: 10.1097/ICO.0000000000001492. — View Citation

Rho CR, Na KS, Yoo YS, Pandey C, Park CW, Joo CK. Changes in anterior and posterior corneal parameters in patients with keratoconus after intrastromal corneal-ring segment implantation. Curr Eye Res. 2013 Aug;38(8):843-50. doi: 10.3109/02713683.2013.788723. Epub 2013 Apr 22. — View Citation

Sögütlü E, Piñero DP, Kubaloglu A, Alio JL, Cinar Y. Elevation changes of central posterior corneal surface after intracorneal ring segment implantation in keratoconus. Cornea. 2012 Apr;31(4):387-95. doi: 10.1097/ICO.0b013e31822481df. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Posterior corneal astigmatism	It is measured by corneal imaging device preoperatively and postoperatively	Baseline to 12 months
Secondary	Visual Acuity	It is measured by Snellen Chart Acuity	Baseline to 12 months