---
title: Evaluation of Effective Lens Position With a Uniplanar Bi-aspheric IOL
nct_id: NCT01248572
overall_status: COMPLETED
phase: PHASE4
sponsor: Lenstec Incorporated
study_type: INTERVENTIONAL
primary_condition: Cataract
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01248572.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01248572"
ct_last_update_post_date: 2014-03-18
last_seen_at: "2026-05-12T06:26:35.713Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Evaluation of Effective Lens Position With a Uniplanar Bi-aspheric IOL

**Official Title:** Evaluation of Lens Effective Position, Stability and Prediction With a 12mm Uniplanar, Biaspheric Intraocular Lens

**NCT ID:** [NCT01248572](https://clinicaltrials.gov/study/NCT01248572)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 40
- **Lead Sponsor:** Lenstec Incorporated
- **Conditions:** Cataract
- **Start Date:** 2010-10
- **Completion Date:** 2012-03
- **CT.gov Last Update:** 2014-03-18

## Brief Summary

The primary goal of this study is to determine the effective lens position (ELP) - or location an intraocular lens (IOL) "sits" in the eye - of the Softec HD IOL. A secondary study goal is to determine if measures of the eye taken prior to surgery can reliably predict postoperative ELP.

## Detailed Description

The primary objective of this study is to determine the effective lens position (ELP) of the study lens, and to report the stability of ELP post-operatively. Additionally, correlations of ELP to predicted postoperative lens position, capsular bag metrics, preoperative biometry and age will be statistically analyzed for determination of ELP prediction via one, or a combination of preoperative variables.

## Eligibility

- **Minimum age:** 40 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* \>=40 years of age, of any race and either gender
* Operable, age related cataract grade 3+ or lower in the study eye
* Able to achieve best corrected visual acuity (BCVA) 20/30 Snellen or better postoperatively in the study eye
* ≤1.0 diopter (D) of corneal astigmatism preoperatively in the study eye
* Able to achieve a dilated pupil \>6.0 millimeter (mm) in the study eye
* Able to adequately visualize the lens equatorial diameter on ultrasound biomicroscopy (UBM) unit (preoperatively)
* Desire implantation of a monofocal lenses targeted at emmetropia in the study eye
* In good general and ocular health
* Able to competently complete testing
* Willing and able to attend study visits
* Willing and able to understand and sign an informed consent

Exclusion Criteria:

* Previous intraocular surgery or laser treatment
* Severe dry eye
* Uncontrolled IOP or glaucoma
* Retinal or macular pathology (i.e. macular degeneration, proliferative diabetic retinopathy, etc.)
* History of retinal detachment
* Microphthalmia
* Chronic severe uveitis
* Corneal decompensation
* Irregular astigmatism
* History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
* Clinically significant corneal endothelial dystrophy (e.g., Fuchs' dystrophy)
* Pseudoexfoliation syndrome
* Iris atrophy
* Pupil abnormalities (e.g., corectopia)
* Aniseikonia
* Amblyopia
* An acute or chronic disease or illness that may confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness)
* Pregnant, lactating, or planning to become pregnant during the course of the trial
* Participation in another clinical trial within 30 days of study start
```

## Arms

- **Softec HD IOL** (EXPERIMENTAL)

## Interventions

- **Softec HD IOL** (DEVICE) — Posterior chamber intraocular lens intended for the replacement of the human crystalline lens following phacoemulsification cataract removal in adults over the age of 21.

## Primary Outcomes

- **Effective Lens Position** _(time frame: 6 Months Postoperative)_ — The position of the intraocular lens - defined by measurement of the aqueous-containing space between the corneal endothelium and the anterior surface of the intraocular lens - once implanted in the capsular bag.

## Locations (3)

- Barnet-Dulaney-Perkins Eye Center, Phoenix, Arizona, United States
- Eye Centers of Florida, Fort Myers, Florida, United States
- Harbin Clinic, Rome, Georgia, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.barnet-dulaney-perkins eye center|phoenix|arizona|united states` — added _(2026-05-12)_
- `locations.eye centers of florida|fort myers|florida|united states` — added _(2026-05-12)_
- `locations.harbin clinic|rome|georgia|united states` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT01248572*  
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