Clinical trial NCT04748198: Effect of Intracorneal Ring Segments on Posterior Corneal Tomography in Eyes With Keratoconus
Official title: Effect of Intracorneal Ring Segments on Posterior Corneal Tomography in Eyes With Keratoconus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratoconus
Keratoconus Posterior
Keywords: keratoconus
intracorneal ring segments
posterior corneal surface
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Posterior corneal astigmatism
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Visual Acuity
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
citation: Sogutlu E, Pinero 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.
citation: 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.
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.