## Protocol Section
### Identification Module
**NCT ID:** NCT01241279

**Brief Title:** Accommodation Measurements After Bilateral Implantation of an Aspheric Accommodating Lens and Monofocal Aspheric Lenses

**Official Title:** A Two Arm Prospective, Randomized, Double-Masked Clinical Evaluation of Accommodation Measurements After Bilateral Implantation of an Aspheric Accommodating Lens and Monofocal Aspheric Lenses

#### Organization Study ID Info
**ID:** 657
#### Organization
**Class:** INDUSTRY
**Full Name:** Bausch & Lomb Incorporated
### Status Module
#### Completion Date
**Date:** 2011-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-11-26

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-11-25

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2011-11

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2014-11-26

**Type:** ESTIMATED

**Results First Submit Date:** 2013-05-17

**Results First Submit QC Date:** 2014-11-25

#### Start Date
**Date:** 2010-10

**Status Verified Date:** 2014-11

#### Study First Post Date
**Date:** 2010-11-16
**Type:** ESTIMATED
**Study First Submit Date:** 2010-11-12
**Study First Submit QC Date:** 2010-11-12
**Why Stopped:** Terminated due to low enrollment
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Bausch & Lomb Incorporated

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The objective of this study is to demonstrate the correlation of near vision and changes in higher order aberrations following lens extraction and to characterize the defocus curves of Crystalens® AO™ intraocular lens (IOL) versus the monofocal aspheric SofPort® LI61AO IOL in adults.

### Conditions Module

**Conditions:**

- Cataract

**Keywords:**

- cataract surgery

- intraocular lens

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 6

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** A silicone multi-piece accommodating intraocular lens

**Intervention Names:**

- Device: Crystalens AO

**Label:** Crystalens AO

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** A silicone multi-piece foldable aspheric intraocular lens

**Intervention Names:**

- Device: SoftPort LI61AO

**Label:** SoftPort LI61AO

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Crystalens AO

**Description:** Participants will undergo small incision cataract surgery (phacoemulsification). At the time of surgery, eligible participants will be implanted bilaterally with the Crystalens AO intraocular lens.

**Name:** Crystalens AO

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- SoftPort LI61AO

**Description:** Participants will undergo small incision cataract surgery (phacoemulsification). At the time of surgery, eligible participants will be implanted bilaterally with the SoftPort LI61AO intraocular lens.

**Name:** SoftPort LI61AO

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** The measurement of optical change in the power of the eye when viewing from far to near. Accommodation decreases as age increases resulting in an inability to focus on near objects.

**Measure:** Amplitude of Accommodation

**Time Frame:** Visit 4 (postoperative day 120-180)

#### Secondary Outcomes

**Description:** Number of correct letters on an early treatment diabetic retinopathy study (ETDRS) chart to measure distance visual acuity and the smallest readable print size on an Minnesota Low-Vision Reading (MNREAD) acuity chart for intermediate and near visual acuity (VA). Visual acuity measured in LogMAR.

**Measure:** Visual Acuity

**Time Frame:** All visits through visit 4 (day 160-180)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Subjects must have clear intraocular media other than cataract.
* Subjects must have a clinically documented diagnosis of age-related bilateral cataracts that are considered amenable to treatment with standard phacoemulsification cataract extraction.
* Subjects must be undergoing primary IOL implantation for the correction of aphakia following central continuous curvilinear anterior capsulorrhexis and phacoemulsification cataract extraction.
* Subjects must require a spherical lens power from 10.00 D to 30.00 D.
* Subjects must be willing and able to return for all scheduled follow-up examinations for each eye from days 1 through 180 following surgery.
* Subjects must have ≤ 1.25 D of preoperative corneal astigmatism.

Exclusion Criteria:

* Subjects with corneal pathology potentially affecting topography.
* Subjects whose fundus cannot be assessed preoperatively.
* Subjects with diagnoses of degenerative visual disorders (eg, macular degeneration, or other retinal disorders) that cause potential acuity losses to a level worse than 20/30 as verified by OCT.
* Subjects with conditions with increased risk of zonular rupture, such as pseudoexfoliation syndrome.
* Subjects who have any active inflammation or edema (swelling) of the cornea, including but not limited to the following: keratitis, keratoconjunctivitis, and keratouveitis.
* Subjects with uncontrolled glaucoma.
* Subjects with previous retinal detachment.
* Subjects with visually significant diabetic retinopathy (proliferative or non-proliferative) which reduces potential acuity to 20/30 or worse.
* Subjects with rubella, bilateral congenital, traumatic, complicated or polar cataract.
* Subjects with marked microphthalmos or aniridia.
* Subjects who have had previous corneal surgery.
* Subjects with irregular corneal astigmatism.
* Subjects with amblyopia which reduces potential acuity to worse than 20/30.
* Subjects with optic atrophy.
* Subjects with iris neovascularization.
* Subjects with clinically significant retinal pigment epithelium/macular changes which reduces potential acuity to 20/30 or worse.
* Subjects with chronic use of systemic steroids or immunosuppressive medications.
* Subjects lacking intact binocular vision.

**Minimum Age:** 40 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Irvine

**Country:** United States

**Facility:** Bausch & Lomb

**State:** California

**Zip:** 92618

#### Overall Officials

**Official 1:**

**Affiliation:** Valeant Pharmaceuticals/Bausch & Lomb Incorporated

**Name:** Johnson Varughese

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007905

- Term: Lens Diseases

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5638

- Name: Cataract

- Relevance: HIGH

- As Found: Cataract

- ID: M10917

- Name: Lens Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002386

- Term: Cataract

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Crystalens AO

**Description:** A silicone multi-piece accommodating intraocular lens

**ID:** EG000

**Other Num at Risk:** 4

**Serious Number At Risk:** 4

**Title:** Crystalens AO

**Group ID:** EG001

**Title:** SoftPort LI61AO

**Description:** A silicone multi-piece foldable aspheric intraocular lens

**ID:** EG001

**Other Num at Risk:** 2

**Serious Number At Risk:** 2

**Title:** SoftPort LI61AO

**Frequency Threshold:** 1

**Time Frame:** 180 days

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 4

**Group ID:** BG001

**Value:** 2

**Group ID:** BG002

**Value:** 6

**Units:** Participants

### Group

**ID:** BG000

**Title:** Crystalens AO

**Description:** A silicone multi-piece accommodating intraocular lens

### Group

**ID:** BG001

**Title:** SoftPort LI61AO

**Description:** A silicone multi-piece foldable aspheric intraocular lens

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 6

**Class Title:** Age 54 to 70 years

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 3

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 3

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** NUMBER
**Title:** Age, Customized
**Unit of Measure:** participants
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**Other Details:** Study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Limitations and Caveats
**Description:** Study terminated early due to lack of enrollment
### Point of Contact
**Email:** Johnson.Varughese@valeant.com
**Organization:** Valeant Pharmaceuticals/Bausch & Lomb
**Phone:** 908-927-1162
**Title:** Johnson Varughese
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
#### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** The measurement of optical change in the power of the eye when viewing from far to near. Accommodation decreases as age increases resulting in an inability to focus on near objects.
**Population Description:** DUE TO THE SMALL SAMPLE SIZE, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS CAN BE MADE.
**Reporting Status:** POSTED
**Time Frame:** Visit 4 (postoperative day 120-180)
**Title:** Amplitude of Accommodation
**Type:** PRIMARY
##### Group
**Description:** A silicone multi-piece accommodating intraocular lens
**ID:** OG000
**Title:** Crystalens AO
##### Group
**Description:** A silicone multi-piece foldable aspheric intraocular lens
**ID:** OG001
**Title:** SoftPort LI61AO
#### Outcome Measure 2
**Description:** Number of correct letters on an early treatment diabetic retinopathy study (ETDRS) chart to measure distance visual acuity and the smallest readable print size on an Minnesota Low-Vision Reading (MNREAD) acuity chart for intermediate and near visual acuity (VA). Visual acuity measured in LogMAR.
**Population Description:** DUE TO THE SMALL SAMPLE SIZE, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS CAN BE MADE.
**Reporting Status:** POSTED
**Time Frame:** All visits through visit 4 (day 160-180)
**Title:** Visual Acuity
**Type:** SECONDARY
##### Group
**Description:** A silicone multi-piece accommodating intraocular lens
**ID:** OG000
**Title:** Crystalens AO
##### Group
**Description:** A silicone multi-piece foldable aspheric intraocular lens
**ID:** OG001
**Title:** SoftPort LI61AO
### Participant Flow Module
#### Group
**Description:** A silicone multi-piece accommodating intraocular lens
**ID:** FG000
**Title:** Crystalens AO
#### Group
**Description:** A silicone multi-piece foldable aspheric intraocular lens
**ID:** FG001
**Title:** SoftPort LI61AO
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 4
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 2
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 4
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 1
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 1
**Pre-Assignment Details:** Due to the small sample size, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS CAN BE MADE.
**Recruitment Details:** A total of 6 subjects (11 eyes) were enrolled at one investigational site in the US. First participant enrolled 10/26/2010; last participant visit 12/01/2011.
**Has Results:** True