Intraoperative tissue separation and immediate visual quality following SMILE performed with VISUMAX800 using different energy and spot spacing parameters
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- UCVA ,CVA
Study Overview
Brief Summary
Intra-operative tissue separation and immediate visual quality following
SMILE performed with VISUMAX 800 using different energy and spot spacing
parameters
A total of 30 non-consecutive patients will receive treatment with the following 6 groups of spot
separation settings, with n=5 patients ( n=10 eyes) in each group.
During and at the end of the procedure, the following parameters will be
evaluated:
-
Time taken for laser delivery ( sec)
-
Severity of the Opaque Bubble Layer( OBL) graded as <25%, <50%,
<75% and & 100%
- Ease of lenticule extraction using the “ No-dissection/ Lenticuloschisis
technique†on a grade of 1-5
4.Number of times Lenticuloschsis could not be performed or was
converted to conventional dissection technique.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 21.00 Year(s) to 40.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •myopia or myopic astigmatism between -2 to -10D.
Exclusion Criteria
- •patients with keratoconus, dry eye, PMD.
Outcomes
Primary Outcomes
UCVA ,CVA
Time Frame: pod1 , pod 15
MANIFEST FREFRACTION OSI MTF
Time Frame: pod1 , pod 15
Secondary Outcomes
- OSI MTF(post op 3 months)
Investigators
Dr Sri Ganesh
CONSULTANT , NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL