Pilot study to compare straylight perception in pseudophakic subjects with different intraocular lenses

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

1. Age 18 or greater
2. Bilateral cataracts for which phacoemulsification cataract extraction and posterior chamber IOL implantation have been planned.
3. Visual potential in each eye of 0.8 (20/25 Snellen) or better as determined by surgeon*s estimation
4. Normal corneal topography with preoperative corneal astigmatism of 1.5 D or less (or the ability to manage astigmatism to 1.0 or less postoperatively by incision placement)
5. Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
6. Signed informed consent

Exclusion Criteria

1. Concurrent participation or participation during the last 30 days in any other clinical trial
2. Use of systemic or ocular medications that may affect vision (the use of any miotic agent is specifically contraindicated)
3. Acute or chronic disease or illness that would increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, diabetes, etc.)
4. Uncontrolled systemic or ocular disease
5. Irregular astigmatism
6. Requiring an intraocular lens <16.0 or >26.0 diopters
7. History of ocular trauma or prior ocular surgery
8. Corneal abnormalities such as stromal, epithelial or endothelial dystrophies
9 10. Uncontrolled ocular hypertension or glaucomatous changes in the retina
11. Intraocular inflammation or recurrent ocular inflammatory condition
12. Known pathology that may potentially affect vision
13. Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils)
14. Capsule or zonule abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, an eccentric anterior capsulorhexis, or posterior capsule defects
15. Retinal changes that may affect vision or that may require surgical intervention during the course of the study (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)
16. Planned moving or moving to another home address during the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>PRIMARY CLINICAL STUDY ENDPOINTS:<br /><br><br /><br>Pre- and postoperative stray light perception measured with the C-Quant<br /><br>(standard and with modified tube), Rostock Glare Perimeter, Double Pass System<br /><br>and a subject questionnaire.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Uncorrected and best corrected distance visual acuities (ETDRS 100% and 25%<br /><br>charts) • Capsular bag striae ratings • IOL Decentration/Tilt • Posterior<br /><br>capsule opacification (PCO) • Optical visual symptom incidence • Complication<br /><br>rates • Adverse event rates • Subjective subject questionnaire</p><br>