# Presentation: 258711

## Anterior Segment Surgeon Training

- The Implantable Miniature Telescope (IMTTM by Dr. Isaac Lipshitz) is an investigational device limited by federal law to investigational use. VisionCare, headquartered in Saratoga, CA, with research facilities in Petah Tikva, Israel, was founded by device inventors Yossi Gross and Dr. Isaac Lipshitz.

**Anterior Segment Surgeon Training**
**for the Implantable Miniature Telescope**

## Outline

- Background
- AMD and Visual Impairment
- Visual Prosthetic Device: IMTTM (by Dr. Isaac Lipshitz)
- Pivotal Clinical Trial Results
- Patient Selection
- Product Description
- Device Implantation Procedure
- Corneal Endothelial Protection
- Complication Management
- Intraoperative
- Postoperative
- Post-Surgical Follow-Up

## BACKGROUND

## AMD & VISUAL IMPAIRMENT

## Key Ocular Anatomy

- Cornea

- Crystalline Lens

- Vitreous

- Iris

- Macula

- Retina

**Key Ocular Anatomy**

- Corneal Endothelium

## MACULAR LESION

- PDT Treated Eye With Small Central Scar

## Retinal Image

- Scarred Macula (Lesion causing scotoma)
- Central Visual Field Projection

- CAT

## Blind spot (scotoma)

- Normal Central Vision

- End-Stage AMD

**Visual Impairment**

## Patient Population

- 50K to 80K/year (US)

**Patient Population**

- Bilateral End-stage AMD =
- Geographic atrophy (advanced dry AMD)
**and/or**
- Disciform scar (Treated or stable wet AMD)
**with associated**
- Moderate to profound visual impairment

## Current Environment

- AMD therapies
- Dry
- No viable therapies
- Wet
- PDT/Drugs slow or halt progression of wet AMD
- Underlying dry AMD still present
- No approved/accepted Tx for end-stage AMD
- Growing elderly population

## Current Environment

*Limited Tools*

**Current Environment**

## VISUAL PROSTHETIC DEVICE 

## The Implantable Miniature Telescope(IMTTM By Dr. Isaac Lipshitz)

*Visual Prosthetic Device*
- Goal: reduce central vision impairment due to scotoma to improve vision and quality of life/ADLs
- Wide-angle properties offer wide field of view

## Micro-optics enlarge central visual field by telephoto effect (2.2 or 3X); macular lesion stable  
Patient utilizes natural eye movements for distance and near vision in either dynamic or static activities 

- Micro-optics enlarge central visual field by telephoto effect (2.2 or 3X); macular lesion stable
- Patient utilizes natural eye movements for distance and near vision in either dynamic or static activities

## PIVOTAL CLINICAL TRIALRESULTS

## Clinical Trials Program

- End-stage (geographic atrophy, disciform scar)

- Phase I (US)
- Complete 2002 (n=13)
- Phase II/III (US)
- Trial complete 2005 (n=217)

*Indication*

*Status*

**Clinical Trials Program**

## Phase II/III Pivotal Trial Results (12 Months)

## PHASE II/III PIVOTAL TRIAL

- Prospective, open-label (fellow eye control)
- 28 Centers
- 217 patients enrolled
- Multi-disciplinary approach
- Retina Specialist, Anterior Segment Surgeon, Optometrist, Visual Rehabilitation Specialist
- Visual rehabilitation (6 visits over 3 months) to utilize new visual status in activities of daily living

## KEY ENTRY CRITERIA

- End-stage AMD; ≥ 55 years old
- Distance VA 20/80 – 20/800
- Minimum 5-letter improvement on ETDRS chart using an external telescope
- Uncompromised peripheral vision
- Endothelial cell density <1600 cells/mm2
- Presence or treatment of active CNV within the preceding 6 months
- Previous intraocular or corneal surgery

## OUTCOME MEASURES

- Safety (12 months+)
- Endothelial cell density (ECD) (target <17% loss)
- Preservation of vision
- Primary Efficacy (12 months)
- 50% of patients gain  2 lines distance or near* VA
- Secondary Efficacy: QoL Outcomes
- NEI Visual Function Questionnaire (VFQ-25)
- Activities of Daily Life (ADL) Scale

- *8” or 16”

## BASELINE CHARACTERISTICS

- Mean Age 75.6 years
- 53% Male
- Mean Distance Visual Acuity 20/316
- ICD-9-CM “Severe” Visual Impairment

## ONE-YEAR RESULTS SUMMARY

**EFFICACY**
- VA endpoint met in **90%** (vs 50% target)
**67%** improved ≥ 3 lines BCDVA
- Meaningful quality of life gains
**SAFETY**
- Preservation of vision met **95%**
- Endothelial cell density (-**25%** vs -17%)

## CLINICAL RESULTS - OPERATIVE

- 206/217 implanted successfully
- 11 aborted procedures
- Implant removed in 5 eyes postop
- 2 condensation inside implant
- 1 patient request (dissatisfaction)
- 2 corneal decompensation

## VISUAL ACUITY ENDPOINT

**% of Patients**

**87%**

**3%**

**90%**
******2 lines**

****

****

**At 12 months (n=192)**

## ACUITY VS FELLOW EYE CONTROL

**Mean Lines Improved**

**p<.0001**

**p<.0001**

- *

- *8” or 16”

## Functional/QoL Improvement

- Mean Change for VFQ Subscales

**Functional/QoL Improvement**

## Functional/QoL Improvement

**Functional/QoL Improvement**

## VISUAL ACUITY AND QOL

**Fellow eye does not show this VA-QoL relationship (p=.5291)**

*** 8 relevant subscales**

## SAFETY

- Preservation of vision achieved
- Mean ECD reduction (target 17%)
- -25% from baseline to 12 months
- -28% from baseline to 24 months (longer-term available data)
- Majority of cell loss at time of surgery (-20%)
- Mean ECD stabilizes over time

## Operated Eye ECD

- Endothelial Cell Density (ECD)

**Operated Eye ECD**

- N=142

- N=186

- N=180

- N=142

- N=186

- N=180

## Endothelial Cell Density

**3 Mos ECD vs POD1 Corneal Edema**

| Edema Level POD1 | Mean ECD Change | % of IMT002 cases |
| --- | --- | --- |
| Normal/1+
 | -12.8% | (75% of cases) |
| ≥ 2+ 
 | -35.1% | (25% of cases) |
| Difference p<.0001;
Significant through 24 months (interim data)
 |  |  |

## LEARNING CURVE

**Mean ECD (cells/mm****2****)**

- Experience Curve

*p=.0045*

*p=.0302*

- p=.1046

- p=.3961

- N=186

- N=180

- N=142

**LEARNING CURVE**

## ADVERSE EVENTS/COMPLICATIONS >5%

| Event | Cumulative |
| --- | --- |
| Ocular Adverse Events | N/206 (%) |
| Inflammatory deposits on device | 44 (21.4) |
| Pigment deposits on device | 20 (9.7) |
| Guttata | 16 (7.8) |
| Posterior synechiae | 13 (6.3) |
| Complications | N/206 (%) |
| Increased IOP req. Rx ≤ 7 days | 57 (27.7) |
| Corneal edema ≤ 30 days | 14 (6.8) |
| Iris prolapse | 12 (5.8) |
| Corneal abrasion | 11 (5.3) |

## RETINA SAFETY

- No postop retinal complications >1%
- 1 CNV recurrence at 7 months
- successfully treated by argon laser photocoagulation through device

## PATIENT SELECTION CRITERIA

*From US Phase II/III Trial*

## Clinical Parameters

- BCVA (distance and near)
- Manifest refraction
- A-Scan (baseline only)
- IOP (by applanation tonometry)
- Slit lamp examination
- Fundus exam and photography (baseline only)
- Fluorescein angiography (baseline only)
- Endothelial cell density (non-contact specular microscope)
- Activities of Daily Life questionnaire/VFQ-25
- Pachymetry

## INCLUSION CRITERIA

*Bilateral, stable untreatable AMD and cataract in study eye (geographic atrophy or disciform scars)*
*Distance BCVA 20/80 – 20/800 and adequate peripheral vision in one eye (non-study eye) to allow navigation*
*5 letter improvement on ETDRS chart in planned operative (study) eye using an external telescope*
**AC depth ******** 2.5mm in study eye**
****** ****55 years of age**

## EXCLUSION CRITERIA

*Active CNV or treatment of active CNV within the past 6 months*
**Hx of intraocular or corneal Sx in study eye**
**Pathology that compromises peripheral vision in fellow eye**

**Study eye has:**
**Myopia >6.0D or Hyperopia >4.0D**
**Axial Length <21mm**
**Endothelial cell density <1600 cells/mm****2**
**Narrow Angle (< Schaefer Grade 2)**
**Corneal disease, inflammatory ocular disease**
*Hx of retinal detachment or untreated tears*
*Retinal vascular or optic nerve disease*
**Zonular weakness/instability of crystalline lens; pseudoexfoliation**
**Uncontrolled glaucoma**

**Magnetic Resonance Imaging (MRI) **
**Due to the metal content found in the device, MRI is contraindicated. **
**The metal content may interfere with the safe use of MRI. MRI incompatibility could put implanted patients at risk of serious injury to ocular and peri-ocular structures due to the effect of magnetic fields on the device. **
**Patients who are known to require, or are scheduled for MRI after surgery, should not be implanted with this device.**

## Other Patient Selection Considerations

**Patient Satisfaction Factors**
- Patient must be self-motivated, not pushed into trial (e.g., children, relatives)
- Patients should have functional goals
- Patient must understand visual rehabilitation is required for adaptation and best potential outcome
- No motor or psychiatric challenges

## Other Patient Selection Considerations

**Patient Satisfaction Factors**
- Psychological: Not a cure, will still have visual impairment
- Visual Acuity: Pre-op external telescope simulation
- Outcome dependent on vision rehabilitation, patient actively using implanted eye, and refraction/spectacles
- Implantation is not the end of treatment, but the beginning

## Other Patient Selection Considerations

**Must understand tradeoff between magnification and visual field in implanted eye**

## Preoperative Testing

**External Telescope Evaluation**
- Using ETDRS
- Patient must achieve at least a 5 letter improvement in study eye (2.2 or 3X)

## Which Eye to Implant?

**If VA is better than 20/200 in either eye, implant worse seeing eye**
**If VA is worse than or equal to 20/200 OU, patient and physician decide which eye is to be implanted**

## Which Eye to Implant?

| Decide... | OD | OS |
| --- | --- | --- |
| Best Corrected 
Visual Acuity | 20/120 | 20/200 |
| Visual Acuity +
Ext. Telescope | 20/60 | 20/80 |

## Which Eye to Implant?

| Decide... | OD | OS |
| --- | --- | --- |
| Best Corrected 
Visual Acuity | 20/400 | 20/400 |
| Visual Acuity +
Ext. Telescope | 20/200 | 20/120 |

**Either eye – patient and physician select**

## Which Eye to Implant?

| Decide... | OD | OS |
| --- | --- | --- |
| Best Corrected 
Visual Acuity | 20/125 | 20/160 |
| Visual Acuity +
Ext. Telescope | 20/50 | 20/60 |

## Which Eye to Implant?

**Pseudophakia**
- OU – excluded
- Unilateral – other criteria applies, but cannot implant pseudophakic eye

## PRODUCT DESCRIPTION

## Glass micro-optical device in PMMA carrier
Diameter 3.6mm
Length 4.4mm
Haptic diameter 13.5mm
Implanted in one eye in the capsular bag for central vision
Field of view 20 - 24° 
Fellow eye for peripheral vision

- Diameter 3.6mm
- Length 4.4mm
- Haptic diameter 13.5mm
- Implanted in one eye in the capsular bag for central vision
- Field of view 20 - 24°
- Fellow eye for peripheral vision

**Specifications**

## Retinal Image

- Scarred Macula (Lesion causing scotoma)
- Central Visual Field Projection

- CAT

## Retinal Image

- CAT

**Retinal Image**

- Wide-Angle Prosthesis
- Central Visual Field Projection

## Field of View vs. External Telescope

- 3.0X Ext. Telescope: 8°

- 3.0X Wide Angle Implant: 20°

**   ****SIMULATION**

## BLIND SPOT DUE TO AMD

- PreOp with Glasses

**Trial patient visual field**
**10-15****° blind spots in central visual field**

***Simulation***

**   ****CASE STUDY**

## PREOP EXTERNAL TELESCOPE

- PreOp with 2.2X External Telescope

**10****° (incomplete) field of view**

**   ****CASE STUDY**

## IMPLANT VIEW 3 MOS POSTOP

- PostOp with 2.2X Implant

**Blind spot reduction (relative) in central visual field**
**25****° field of view**** **

**   ****CASE STUDY**

## Technical Specifications

| Design Element | WA 3.0X IMT
& WA 2.2X IMT |
| --- | --- |
| Optic | Glass tube with microlenses |
| Dimensions | Diameter: 3.6mm
Length: 4.4mm |
| Haptic diameter | 13.5mm |
| Haptic plate diameter | 7.0mm |
| Carrier 
(haptics & plate) | Clear PMMA |
| Light Restrictor | Blue PMMA |
| Depth of focus | 1.5 m – 10 m  |
| Weight | ~115mg(air); 60mg(aqueous) |

## DEVICE IMPLANTATION PROCEDURECorneal Endothelial Protection

## Surgical Procedure Precautions

- Device geometry/volume create challenging procedure with no shortcuts.
- The risk of endothelial cell loss is significantly higher than intraocular lens implantation procedures.
- Special care should be taken to minimize the risk of corneal endothelial cell loss including attention to proper patient selection, appropriate surgical techniques, device handling precautions, selection and use of ocular viscoelastic devices, wound management, appropriate post-procedure medications and patient instructions.

## Surgical Procedure Precautions

- Corneal decompensation resulting from operative complications necessitating device removal, IOL implantation, and penetrating keratoplasty has occurred in two patients participating in a pivotal clinical evaluation of the device.

## Unique Geometrical Considerations

**Unique Geometrical Considerations**

- IOL

- VISUAL PROSTHESIS

## Procedure Overview

- _Not_ an IOL
- 12 mm limbal incision
- Large capsulorrhexis
- 7 mm ideal
- Implantation entry angle must be away from cornea during implantation (towards PC through limbal incision)
- Depress implant in AC away from cornea
- Viscoelastics critical
- Cohesive in bag & fill AC
- Dispersive to coat endothelium/device

## Anesthesia (retro- or peri-bulbar injection)
Mydratic agents to ensure adequate intraoperative pupil dilation
Lid speculum placed to provide maximum corneal exposure
Operating microscope positioned over front of operative eye with illumination to provide adequate visualization during procedure

- Mydratic agents to ensure adequate intraoperative pupil dilation
- Lid speculum placed to provide maximum corneal exposure
- Operating microscope positioned over front of operative eye with illumination to provide adequate visualization during procedure

**Patient Preparation**

## Dilate pupil maximally and create 12-13 mm conjunctival incision and achieve hemostasis
Create 12 mm partial thickness limbal groove
Note: Less beveled incision allows advantageous device entry angle into AC 
CAUTION: DO NOT MAKE SMALLER INCISION AS IT WILL MAKE DEVICE IMPLANTATION MORE DIFFICULT

- Create 12 mm partial thickness limbal groove
- Note: Less beveled incision allows advantageous device entry angle into AC
- CAUTION: DO NOT MAKE SMALLER INCISION AS IT WILL MAKE DEVICE IMPLANTATION MORE DIFFICULT

**Incision Construction**

## Make paracentesis and inject ophthalmic viscosurgical devices (OVD) into the AC (e.g., “softshell technique”)
Coat endothelium with dispersive OVD
Fill AC with cohesive OVD

- Coat endothelium with dispersive OVD
- Fill AC with cohesive OVD

**Ophthalmic Viscoelastic Devices**

## Create capsulorhexis of 7mm
CAUTION: DO NOT MAKE SMALLER CAPSULORHEXIS – MAKES DEVICE IMPLANTATION MORE DIFFICULT
DO NOT IMPLANT DEVICE IF CAPSULE INTEGRITY COMPROMISED
	Phacoemulsification is performed to remove the natural lens utilizing settings that help preserve endothelial cells.  Special care should be taken to remove any cortical remnants and polish the posterior capsular bag. 

- CAUTION: DO NOT MAKE SMALLER CAPSULORHEXIS – MAKES DEVICE IMPLANTATION MORE DIFFICULT
- DO NOT IMPLANT DEVICE IF CAPSULE INTEGRITY COMPROMISED
*	**Phacoemulsification is performed to remove the natural lens utilizing settings that help preserve endothelial cells.  Special care should be taken to remove any cortical remnants and polish the posterior capsular bag. *

**Capsulorhexis**

## Handling the IMT

**Handling the IMT**

**Cover with visco**

## The device is comprised of a glass optical apparatus. Damage (micro-cracks) can be induced due to trauma to the devices during handling an manipulation.   
Compression of the optical element of the device resulting from improper handling surgical instruments can induce such a failure. 
The haptics are stiff - use of sharp forceps which, when manipulated aggressively, can induce forces sufficient to damage or break the loops of the device.

- Compression of the optical element of the device resulting from improper handling surgical instruments can induce such a failure.
- The haptics are stiff - use of sharp forceps which, when manipulated aggressively, can induce forces sufficient to damage or break the loops of the device.

**Device Handling**

## CONDENSATION DUE TO CRACK IN DEVICE

## Anterior Segment “Softshell technique”:
Coat endothelium with dispersive OVD (e.g., Viscoat);  
then cohesive OVD (e.g., Healon V or other viscoadaptive/cohesive OVD) is injected to fill the AC and capsular bag. 
Note: lower viscosity OVDs may “burp” out     	 during device insertion.     
Device: A dispersive OVD (e.g., Viscoat or equivalent) is used to liberally coat the device (optical portion and leading haptic).  
Enlarge the incision to 12 mm. 

- Coat endothelium with dispersive OVD (e.g., Viscoat);
- then cohesive OVD (e.g., Healon V or other viscoadaptive/cohesive OVD) is injected to fill the AC and capsular bag.
- Note: lower viscosity OVDs may “burp” out     	 during device insertion.
- _Device_: A dispersive OVD (e.g., Viscoat or equivalent) is used to liberally coat the device (optical portion and leading haptic).
- Enlarge the incision to 12 mm.

**Device Insertion: OVD & Incision Prep**

## Grasp the device by the device’s carrier plate;
Lift the cornea maximally while avoiding “tenting;”
Avoid contact with the corneal endothelium;
Insert the leading loop into the bag with device at approximately 45 degrees to the horizontal plane;

- Lift the cornea maximally while avoiding “tenting;”
- _Avoid_ contact with the corneal endothelium;
- Insert the leading loop into the bag with device at approximately 45 degrees to the horizontal plane;

**Device Insertion: Implantation**

**Implant device into capsular bag:**

**Avoid Corneal Touch**

**Avoid Corneal Touch**

## Both loops must be placed inside the capsular bag. Direct placement using a superior haptic compression technique should be employed.  Dialing the trailing haptic into position should be avoided as the haptics are too stiff.
A second instrument through the paracentesis incision may be helpful in holding the device steady during trailing haptic placement. 
The device is bimanually rotated to a 12:6 o’clock position (using clockwise rotation).

- A second instrument through the paracentesis incision may be helpful in holding the device steady during trailing haptic placement.
- The device is bimanually rotated to a 12:6 o’clock position (using clockwise rotation).

**Device Insertion: Implantation**

**Implant device into capsular bag:**

## Handle the device only by the carrier and haptics. 
Do not touch or grasp the optical glass cylinder with surgical instruments. 
Liberally coat the device with dispersive OVD prior to insertion.
Avoid corneal touch during the implant procedure.
Iris damage increases the risk of endothelial cell loss.

- Do not touch or grasp the optical glass cylinder with surgical instruments.
- Liberally coat the device with dispersive OVD prior to insertion.
- Avoid corneal touch during the implant procedure.
- Iris damage increases the risk of endothelial cell loss.

**Device Insertion: Precautions**

**Both Loops In-The-Bag**

## Once device is in place, place several uninterrupted sutures to create water-tight incision and prevent shallowing AC.
Constrict pupil.
Irrigate and meticulously aspirate OVD to minimize postop IOP spikes.
Special care to be taken to remove OVD between the carrier plate and capsular bag
Peripheral iridectomy is performed.
Additional sutures are placed to close wound and knots are trimmed and buried.
Test incision for leakage.

- Constrict pupil.
- Irrigate and meticulously aspirate OVD to minimize postop IOP spikes.
- Special care to be taken to remove OVD between the carrier plate and capsular bag
- Peripheral iridectomy is performed.
- Additional sutures are placed to close wound and knots are trimmed and buried.
- Test incision for leakage.

**Wound Closure**

## Sub-Tenon’s steroid injection
betamethasone (Celestone) 6mg
methylprednisolone (Solumedrol) 100mg
Or appropriate substitute

- betamethasone (Celestone) 6mg
- methylprednisolone (Solumedrol) 100mg
- Or appropriate substitute

**Anti-Inflammatory Injection**

## SURGICAL VIDEO

## COMPLICATIONMANAGEMENTINTRA-OPERATIVE

## Potential Intraoperative Surgical Complications

- Capsular rupture
- Small capsulorhexis – inability to place loops
- Corneal touch
- Malpositioned IMT
- Vitreous bulge/loss

## Intraoperative Surgical Complication Management  

| Complication | Action |
| --- | --- |
| Haptic not in the bag, inability to place loops (malpositioned device) | Do not manipulate haptic into the bag, risk of capsular rupture

Place haptics in sulcus, or
cut haptics and remove device -implant a back-up device or an IOL |
| Capsular rupture | Cut haptics and remove IMT; implant an IOL |
| Choroidal hemorrhage | Remove device immediately and close wound |
| Radial tears in the capsule | Do not implant device, place an IOL |

## COMPLICATIONMANAGEMENTPOST-OPERATIVE

## Potential Post-Op Complications/AEs 

- Malpositioned IMT
- Mechanical failure of device
- Explant
- Posterior capsule opacification
- Transient shallow AC
- Inflammatory reaction & hypopyon
- Fibrin deposition on IMT
- Photophobia
- Corneal edema
- Synechiae
- Hyphema
- Endothelial cell loss/corneal decompensation

## Potential Post-Op Complications/AEs 

- Most require actions/management similar to intraocular lenses
- Posterior capsule opacification and explants described next...

## Posterior Capsule Opacification

**Manual capsulotomy**
- Pars plana entry capsulotomy (needle or vitrector)
**YAG capsulotomy**
- do not fire laser through the telescope optic
- has been performed around periphery of IMT in an animal study with favorable results

## Explanting the device is possible
Explanted eyes may be re-implanted with a PC-IOL
Cut haptics and remove telescope prosthetic device
INSERT EXPLANT VIDEO HERE FOR EXAMPLE

- Explanted eyes may be re-implanted with a PC-IOL
- Cut haptics and remove telescope prosthetic device
**INSERT EXPLANT VIDEO HERE FOR EXAMPLE**

**Explanting the IMT**

## POST-SURGICAL FOLLOW-UP

## Trial Protocol

**Medical examinations at:**
- 1 day
- 1  week
- 1, 3, 6, 9, 12, 18, 24 months
**Each examination includes:**
- Surgical evaluation
- Visual acuity (distance & near)
- Functional evaluation (3-12 months)
**Postop referral to credentialed rehabilitation therapist**

## Recommended Visit Schedule

| EXAM/TEST | Pre-op | Day 1 | Day 7 | 1 Mo. | 3 Mos | 6 Mos | 12 Mos |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Distance  BCVA |  |  |  |  |  |  |  |
| Near BCVA |  |  |  |  |  |  |  |
| Manifest Refraction |  |  |  |  |  |  |  |
| IOP |  |  |  |  |  |  |  |
| Slit Lamp Exam |  |  |  |  |  |  |  |
| Fluorescein angiography |  |  |  |  |  |  |  |
| Dilated Fundus Exam  |  |  |  |  |  |  |  |
| Specular Microscopy (optional) |  |  |  |  |  |  |  |
| ADL & VFQ-25 Questionnaire (optional) |  |  |  |  |  |  |  |

## Topical antibiotic
NSAID – diclofenac sodium (0.1%)
Topical steroids – predinisolone acetate (1%)
q2h for first 2 weeks; q4h for next 2-4 weeks; taper over the next 4-6 weeks.  (About 3 months total duration)
Mydriatics 
Homatropine 5% b.i.d. 4-6 weeks
Atropine may be used if homatropine inadequate to maintain cycloplegia
Miotics 
Only in case of glare

**NSAID – diclofenac sodium (0.1%)**
**Topical steroids – predinisolone acetate (1%)**
- q2h for first 2 weeks; q4h for next 2-4 weeks; taper over the next 4-6 weeks.  (About 3 months total duration)
**Mydriatics **
- Homatropine 5% b.i.d. 4-6 weeks
- Atropine may be used if homatropine inadequate to maintain cycloplegia
**Miotics **
- Only in case of glare

**Post-Op Medical Treatment**

## Post-Op Medical Treatment

- 	Caution:   The above postoperative regimen of anti-inflammatory medications may be too aggressive for some patients and could result in medicamentosa.  The physician should exercise clinical judgment in deciding if a more moderate or rapid tapering of the topical steroid regimen is indicated for some patients.

## Refraction

- Ophthalmoscopy is challenging through the IMT
- Use 90D Lens
- Clinical refraction may be evaluated with +/- 1.0 and 2.0 diopter lenses
- Astigmatic correction should be added but is often only minimally helpful
- Add powers may be helpful

## Keys to Successful Surgical Outcomes

- Challenging surgical procedure
- Use special implantation technique to avoid corneal touch
- Use OVD to maintain AC and protect endothelium from device
- At least 12 mm incision necessary
- Large capsulorhexis (7 mm) necessary
- Prescribe extended anti-inflammatory drug regimen