Verisyse Phakic Refractive IOL: Outcomes and Complications

1
Verisyse Phakic Refractive IOL Outcomes and
Complications
Richard M. Awdeh1, MD, Alan N. Carlson1, MD Dept.
of Ophthalmology1, Duke University Medical
Center, Durham, NC
Verisyse Phakic Refractive IOL Outcomes and
Complications Richard M. Awdeh, MD, Alan N.
Carlson, MD Department of Ophthalmology Duke
University Medical Center, Durham NC
































2
Verisyse Phakic Refractive IOL Outcomes and
Complications
Richard M. Awdeh1, MD, Alan N. Carlson1, MD Dept.
of Ophthalmology1, Duke University Medical
Center, Durham, NC
Purpose
To determine outcomes and complications in
surgical implantation of the AMO Verisyse phakic
refractive intraocular lens in highly myopic
patients.
































3
Verisyse Phakic Refractive IOL Outcomes and
Complications
Richard M. Awdeh1, MD, Alan N. Carlson1, MD Dept.
of Ophthalmology1, Duke University Medical
Center, Durham, NC
Materials and Methods
A retrospective study was conducted comprising a
total of 19 eyes of 13 patients who underwent
surgical insertion of the Verisyse phakic
refractive lens (PRL) at the Duke University Eye
Center. All procedures were performed by the
same surgeon (AC). Surgical indications included
high myopia in patients considered poor
candidates for LASIK surgery due to one or more
reasons.
































4
Verisyse Phakic Refractive IOL Outcomes and
Complications
Richard M. Awdeh1, MD, Alan N. Carlson1, MD Dept.
of Ophthalmology1, Duke University Medical
Center, Durham, NC
Materials and Methods
Patient age, sex, preoperative keratometry
values, axial length, pachymetry, endothelial
cell count, topography, and visual acuities were
obtained preoperatively. Preoperative best
visual acuity was determined through manifest
refraction in all patients. Patients were
followed with serial examinations at 1 day, 1
week, 1 month, 3 months, 6 months, and 1 year
following intervention.
































5
Verisyse Phakic Refractive IOL Outcomes and
Complications
Richard M. Awdeh1, MD, Alan N. Carlson1, MD Dept.
of Ophthalmology1, Duke University Medical
Center, Durham, NC
Materials and Methods
The average patient age was 40.8 years (range
24 57 years) 5 patients were males and 8 were
female average axial length was 27.85 mm (range
25.8 31.16 mm) average preoperative pachymetry
was 509.5 um (range 464 570 um) and avereage
endothelial cell count was 2988 cells (range
2538 3773 cells).
































6
Verisyse Phakic Refractive IOL Outcomes and
Complications
Richard M. Awdeh1, MD, Alan N. Carlson1, MD Dept.
of Ophthalmology1, Duke University Medical
Center, Durham, NC
Materials and Methods
All patients had a preoperative uncorrected
visual acuity of count fingers. The average best
corrected visual acuity (BCVA) prior to surgery
was 0.037 logMAR (approximately 20/20 2) and
the average preoperative myopia was a spherical
equivalent of -12.18 diopters (range -9.25
19.25 D). The mean follow-up time was 212 days
(range 39 396 days).
































7
Verisyse Phakic Refractive IOL Outcomes and
Complications
Richard M. Awdeh1, MD, Alan N. Carlson1, MD Dept.
of Ophthalmology1, Duke University Medical
Center, Durham, NC
Materials and Methods
Table 1 Summary of Patient Demographics.
































8
Verisyse Phakic Refractive IOL Outcomes and
Complications
Richard M. Awdeh1, MD, Alan N. Carlson1, MD Dept.
of Ophthalmology1, Duke University Medical
Center, Durham, NC
Materials and Methods
Figure 1 Distribution of Preoperative Myopia.
































9
Verisyse Phakic Refractive IOL Outcomes and
Complications
Richard M. Awdeh1, MD, Alan N. Carlson1, MD Dept.
of Ophthalmology1, Duke University Medical
Center, Durham, NC
Results Outcomes
84 of patients retained or improved on their
preoperative best corrected visual acuity (BCVA).
All of our patients had a preoperative
uncorrected visual acuity (UCVA) of count fingers
and the average preoperative BCVA was 0.037
logMAR. This compares with an average
postoperative UCVA of 0.071 logMAR and BCVA of
-0.015 logMAR.
































10
Verisyse Phakic Refractive IOL Outcomes and
Complications
Richard M. Awdeh1, MD, Alan N. Carlson1, MD Dept.
of Ophthalmology1, Duke University Medical
Center, Durham, NC
Results Complications
Three patients had a decreased BCVA (equal to
one line) following the procedure. Complications
following lens implantation included
de-enclavation of a defective lens requiring lens
exchange temporary filtering bleb acute
postoperative angle closure glaucoma early
cataract changes in two eyes elevated
intraocular pressure in three eyes broken suture
resulting in a hyphema.
































11
Verisyse Phakic Refractive IOL Outcomes and
Complications
Richard M. Awdeh1, MD, Alan N. Carlson1, MD Dept.
of Ophthalmology1, Duke University Medical
Center, Durham, NC
Results
Figure 2 Change in Best Corrected Visual Acuity
(BCVA) after Verisyse Implantation.
































12
Verisyse Phakic Refractive IOL Outcomes and
Complications
Richard M. Awdeh1, MD, Alan N. Carlson1, MD Dept.
of Ophthalmology1, Duke University Medical
Center, Durham, NC
Results
Figure 3 Refraction Prediction Results.
































13
Verisyse Phakic Refractive IOL Outcomes and
Complications
Richard M. Awdeh1, MD, Alan N. Carlson1, MD Dept.
of Ophthalmology1, Duke University Medical
Center, Durham, NC
Discussion

• The majority of patients who underwent
  implantation of the Verisyse lens at the Duke Eye
  Center experienced favorable visual outcomes.
  Only 3 patients experienced a decrease in BCVA
  compared with pre-operative BCVA, however, we
  feel that there is a lead-time bias in these
  patients as they have not had adequate follow-up
  yet. Most of our patients required at least 4
  weeks of follow-up before achieving a stable
  BCVA. We feel that the number of patients who
  achieve a BCVA equal to or greater than that
  pre-operatively will increase once adequate
  follow-up has been achieved in all patients.

14
Verisyse Phakic Refractive IOL Outcomes and
Complications
Richard M. Awdeh1, MD, Alan N. Carlson1, MD Dept.
of Ophthalmology1, Duke University Medical
Center, Durham, NC
Discussion

• While lens insertion was achieved without
  complication in most patients, we did experience
  some minor complications. The most serious of
  these was de-enclavation of the iris from the
  iris claws of the Verisyse lens in one patient
  (Figure 4). When surgical re-enclavation was
  attempted, we discovered that one of the arms of
  the lens was defective in its ability to enclave
  iris and a lens exchange was performed.

15
Verisyse Phakic Refractive IOL Outcomes and
Complications
Richard M. Awdeh1, MD, Alan N. Carlson1, MD Dept.
of Ophthalmology1, Duke University Medical
Center, Durham, NC
Discussion
Figure 4 De-enclavation of Verisyse lens.
































16
Verisyse Phakic Refractive IOL Outcomes and
Complications
Richard M. Awdeh1, MD, Alan N. Carlson1, MD Dept.
of Ophthalmology1, Duke University Medical
Center, Durham, NC
Discussion

• One patient experienced acute post-operative
  angle closure glaucoma though she had a surgical
  peripheral iridotomy placed during the procedure.
  A laser peripheral iridotomy was performed
  post-operatively and the patient responded with a
  decrease in IOP. The final post-opertaive BCVA
  in this patient was 20/25 -1.

17
Verisyse Phakic Refractive IOL Outcomes and
Complications
Richard M. Awdeh1, MD, Alan N. Carlson1, MD Dept.
of Ophthalmology1, Duke University Medical
Center, Durham, NC
Discussion

• Another patient developed a temporary superior
  filtering bleb (below) following lens
  implantation. This patient was managed with
  topical antibiotics and steroids and the bleb
  resolved.

18
Verisyse Phakic Refractive IOL Outcomes and
Complications
Richard M. Awdeh1, MD, Alan N. Carlson1, MD Dept.
of Ophthalmology1, Duke University Medical
Center, Durham, NC
Discussion

• Two patients have early cataract formation, one
  has an early nuclear sclerosing cataract and one
  has early anterior subcapsular cataract changes
  (Figure 5).

19
Verisyse Phakic Refractive IOL Outcomes and
Complications
Richard M. Awdeh1, MD, Alan N. Carlson1, MD Dept.
of Ophthalmology1, Duke University Medical
Center, Durham, NC
Discussion
Figure 5 Anterior subcapsular cataract formation
following PRL insertion.
































20
Verisyse Phakic Refractive IOL Outcomes and
Complications
Richard M. Awdeh1, MD, Alan N. Carlson1, MD Dept.
of Ophthalmology1, Duke University Medical
Center, Durham, NC
Discussion
Figure 6 Example of excessive enclavation of
lens claws.
































21
Verisyse Phakic Refractive IOL Outcomes and
Complications
Richard M. Awdeh1, MD, Alan N. Carlson1, MD Dept.
of Ophthalmology1, Duke University Medical
Center, Durham, NC
Discussion
Figure 7 Example of good enclavation of lens
claws.
































22
Verisyse Phakic Refractive IOL Outcomes and
Complications
Richard M. Awdeh1, MD, Alan N. Carlson1, MD Dept.
of Ophthalmology1, Duke University Medical
Center, Durham, NC
Discussion

• Other minor complications include hyphema
  following a suture removal in one patient, which
  resolved without event, and elevated IOP
  following lens insertion which eventually
  returned to normal. IOP. IOP elevation is
  either due to a steroid response or to AC
  inflammation induced by the surgery.

23
Verisyse Phakic Refractive IOL Outcomes and
Complications
Richard M. Awdeh1, MD, Alan N. Carlson1, MD Dept.
of Ophthalmology1, Duke University Medical
Center, Durham, NC
Discussion

• Other minor complications include hyphema
  following a suture removal in one patient, which
  resolved without event, and elevated IOP
  following lens insertion which eventually
  returned to normal. IOP. IOP elevation is
  either due to a steroid response or to AC
  inflammation induced by the surgery.

24
Verisyse Phakic Refractive IOL Outcomes and
Complications
Richard M. Awdeh1, MD, Alan N. Carlson1, MD Dept.
of Ophthalmology1, Duke University Medical
Center, Durham, NC
Discussion
Figure 8 Video of lens enclavation technique.
































25
Verisyse Phakic Refractive IOL Outcomes and
Complications
Richard M. Awdeh1, MD, Alan N. Carlson1, MD Dept.
of Ophthalmology1, Duke University Medical
Center, Durham, NC
Conclusions

• The Verisyse Phakic Refractive Lens is an
  excellent alternative for many patients with high
  myopia who are not suitable candidates for LASIK
  surgery.
• Our preliminary results demonstrate an
  overwhelming majority of patients will maintain
  or improve Best Corrected Visual Acuity following
  lens implantation.
• Minor complications are outlined above longer
  term complications will be reported in a future
  study.
• A learning curve may be present in lens
  implantation.