Documentazione distribuita da A.I.CHE. - Associazione Italiana CHEratoconici ONLUS (www.assocheratocono.org)
Clinical results phase II study
6 months follow-up
Farhad Hafezi, MD
Institute for Refractive and Ophthalmic surgery
Zurich, Switzerland
Farhad Hafezi, MD
Phase II study, 6 months follow-up
Documentazione distribuita da A.I.CHE. - Associazione Italiana CHEratoconici ONLUS (www.assocheratocono.org)
IROC
Clinical phase II study
Farhad Hafezi, MD
Phase II study, 6 months follow-up
Documentazione distribuita da A.I.CHE. - Associazione Italiana CHEratoconici ONLUS (www.assocheratocono.org)
Study sites with data of 6 months follow-up
• Number of study sites: 11
• Total of eyes enrolled in all study sites: 87 (dec 2006)
• 6 months follow-up:
• Zurich
14 eyes
• Brussels
4 eyes
• Milan
14 eyes
Farhad Hafezi, MD
Phase II study, 6 months follow-up
Documentazione distribuita da A.I.CHE. - Associazione Italiana CHEratoconici ONLUS (www.assocheratocono.org)
Data analyzed
• Rare complications
all sites
• Pre- and post-op max K-values
all sites
• Pre- and post-op BSCVA
all sites
• Keratoconus index
Zurich
• EC counting
Milan
Farhad Hafezi, MD
Phase II study, 6 months follow-up
Documentazione distribuita da A.I.CHE. - Associazione Italiana CHEratoconici ONLUS (www.assocheratocono.org)
Rare complications
• Feasibility and proof of concept given by phase I study
• Aim of phase II study
• Detect rare complications
• Further refinement of the method
No complications found in study patients
Farhad Hafezi, MD
Phase II study, 6 months follow-up
Documentazione distribuita da A.I.CHE. - Associazione Italiana CHEratoconici ONLUS (www.assocheratocono.org)
Maximal K- values: change after 6 months
• Significant decrease:
- 0.6 D ± 1.7
(p = 0.049, t = 2.055 )
• Degree of change of K-values does not correlate with the
height of preoperative K-values
Farhad Hafezi, MD
Phase II study, 6 months follow-up
Documentazione distribuita da A.I.CHE. - Associazione Italiana CHEratoconici ONLUS (www.assocheratocono.org)
Maximal K- values: change after 6 months
• Significant decrease: - 0.6 D ± 1.7
(p = 0.049, t = 2.055 )
• Degree of change of K-values does not correlate with the
height of preoperative K-values
Farhad Hafezi, MD
Phase II study, 6 months follow-up
Documentazione distribuita da A.I.CHE. - Associazione Italiana CHEratoconici ONLUS (www.assocheratocono.org)
BSCVA pre- and post-operative
• Zurich and Brussels, 22 eyes
• No significant change
• P = 0.44, t = 0.78
• Mean LogMAR VA
• Preoperative 0.25 (SD 0.22, Range 0-0.70 )
• Postoperative 0.25 (SD 0.21, Range 0-0.70 )
• 6 months follow-up too early
Farhad Hafezi, MD
Phase II study, 6 months follow-up
Documentazione distribuita da A.I.CHE. - Associazione Italiana CHEratoconici ONLUS (www.assocheratocono.org)
Keratoconus index
• Zurich: 14 eyes
• No significant change after 6 months
• Longer waiting time for follow-up
Farhad Hafezi, MD
Phase II study, 6 months follow-up
Documentazione distribuita da A.I.CHE. - Associazione Italiana CHEratoconici ONLUS (www.assocheratocono.org)
Endothelial cell loss
• Milan, 14 eyes
• Preoperative EC count
Mean 2’613 ± 250
Range 2’109 to 3’030
• Postoperative EC count
Mean 2’334 ± 330
Range 1’680 to 2’739
• Absolute changes
-272 ± 359
• Relative changes
-9.91% ± 13%
Farhad Hafezi, MD
Phase II study, 6 months follow-up
Range 4.1% to -39%
Documentazione distribuita da A.I.CHE. - Associazione Italiana CHEratoconici ONLUS (www.assocheratocono.org)
Endothelial cell loss
• Milan, 14 eyes
Farhad Hafezi, MD
Phase II study, 6 months follow-up
Documentazione distribuita da A.I.CHE. - Associazione Italiana CHEratoconici ONLUS (www.assocheratocono.org)
Endothelial cell loss
Milan, 14 eyes
•
Distinct trend: Correlation between
preoperative corneal thickness and
endothelial cell loss
•
Central EC loss after phaco: up to 28%
Is a rise in the minimal preoperative corneal thickness necessary?
Probably yes!
Farhad Hafezi, MD
Phase II study, 6 months follow-up
Documentazione distribuita da A.I.CHE. - Associazione Italiana CHEratoconici ONLUS (www.assocheratocono.org)
3nd International Congress of Corneal Cross Linking
Hotel Hilton Airport, Zurich/ Switzerland
December 7-8, 2007
www.ccl-congress.ch
Farhad Hafezi, MD
Phase II study, 6 months follow-up