Comparison of Quality of Vision After Bifocal and Extended Depth of Focus Intraocular Lens Implantation
- Conditions
- Intraocular Lens
- Interventions
- Procedure: Clear corneal phacoemulsification and IOL implantation
- Registration Number
- NCT04557579
- Lead Sponsor
- Taipei Nobel Eye Clinic
- Brief Summary
To compare the visual performance of the extended depth of focus (EDOF) intraocular lens (IOL) to bifocal and spherical monofocal IOL
- Detailed Description
This study was conducted from 2018 to 2020. This study included patients who were with presence of cataract in both eyes, age between 50 and 80 years, and corrected distance visual acuity (CDVA) of both eyes under 20/40. Phacoemulsification cataract surgery was arranged for both eyes for all patients. The study groups of IOL models include EDOF Symfony IOL (AMO, Santa Ana, CA, USA), bifocal Restor +2.5D IOL (Alcon, Fort Worth, TX, USA), and monofocal Sensar AR40e IOL (AMO, Santa Ana, CA, USA). The patients were routinely examined preoperatively as well as 1 month after surgery for far and near visual acuity (in LogMAR unit). Contrast sensitivity, wavefront aberration and quality of vision questionnaire was measured at the 1-month postoperative visit. These aforementioned outcomes were recorded and compared between groups.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 97
- presence of cataract in both eyes
- age between 50 and 80 years
- CDVA of both eyes under 20/40
- Phacoemulsification cataract surgery was arranged for both eyes
- complicated cataract
- corneal opacities or irregularities
- corneal astigmatism > 1.5 diopter
- dry eye (Schirmer's test I ≤ 5mm)
- amblyopia
- anisometropia
- surgical complications such as posterior capsular bag rupture or vitreous loss
- IOL tilt or decentration
- coexisting ocular pathologies
- glaucoma
- non-dilating pupil
- history of intraocular surgery, laser therapy, or retinopathy
- optic nerve or macular diseases
- refusal or unable to maintain follow-up.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Bifocal group Clear corneal phacoemulsification and IOL implantation Patients in bifocal group implanted with Restor +2.5D IOL (Alcon, Fort Worth, TX, USA) in bilateral eyes Extended depth of focus group Clear corneal phacoemulsification and IOL implantation Patients in extended depth of focus group implanted with EDOF Symfony IOL (AMO, Santa Ana, CA, USA) in bilateral eyes Monofocal group Clear corneal phacoemulsification and IOL implantation Patients in monofocal group implanted with Sensar AR40e IOL (AMO, Santa Ana, CA, USA) in bilateral eyes
- Primary Outcome Measures
Name Time Method Wavefront examination at the 1-month postoperative visit Wavefront analysis was performed only at the 1-month postoperative visit with an AMO WaveScan Hartmann-Shack sensor (Santa Clara, CA, USA). The wavefront maps were analyzed using a 6-mm pupil diameter and a Zernike polynomial expansion up to the sixth-order of Zernike coefficients. Higher order aberrations including RMS errors of horizontal coma aberration (Z 3,1), spherical aberration (4,0), trefoil aberration and the higher order aberrations were assessed.
Contrast sensitivity at the 1-month postoperative visit CS was also measured at the 1-month postoperative visit using the Vector Vision CSV-1000 (Greenville, OH, USA) chart. All subjects were tested at the recommended distance of 8 feet. The CSV-1000 consists of a series of circular achromatic sine-wave patches having a 1.5-in. diameter and comprising 4 rows, each corresponding to one of 4 spatial frequencies: 3, 6, 12, and 18 cycles per degree (cpd). We selected 3, 6 and 12 cpd for analysis.
Questionnaire at the 1-month postoperative visit Subjective QoV was evaluated using a questionnaire adopted from a near-activity 19-item questionnaire and the NEI-RQL-42. Our questionnaire contains 11 questions and the subscales include far vision, diurnal fluctuation, glare and halos, spectacle dependence, near vision, and intermediate vision. In general, questionnaires were completed without assistance; however, on the patient's request, explanations of the questions were provided.
Ophthalmic examinations 1 month after surgery. far uncorrected visual acuity(UCVA) and corrected distance visual acuity (CDVA), near UCVA in LogMAR unit
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Taipei Nobel Eye Clinic
🇨🇳Taipei, Taiwan