Corneal Astigmatism Clinical Trial
Official title:
Toric Intraocular Lens (IOL) Implantation Compared to Incisional Surgery to Correct Corneal Astigmatism as Part of Cataract Surgery - A Randomised Controlled Clinical Trial
The purpose of the study is to compare the astigmatism reducing effect of a toric intraocular lens (IOL) (model MX60T - Bausch & Lomb) with that of limbal relaxing incisional surgery combined with a non toric IOL (model MX60 - Bausch & Lomb) in patients with corneal astigmatism between 1.0 and 1.5 diopters and also the effect of cylinder reduction on patient's quality of vision.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | August 2019 |
Est. primary completion date | August 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: - Bilateral cataract. - Age 21 and older. - Written informed consent to sequential bilateral surgery and participation in the study. - Preoperative pupil size greater than or equal to 5.0 mm in the study eye. - IOL power as predicted by biometry ranging from 6.0 D to 30.0 D in both eyes. - Regular corneal astigmatism according to Orbscan topography. - Postoperative corneal astigmatism between 0.90 D and 1.40 D in both eyes, as predicted by the Bausch + Lomb Toric Calculator (https://envista.toriccalculator.com). Exclusion Criteria: - Ocular comorbidity (corneal scars, amblyopia, retina, or optic nerve disease) that may reduce postoperative CDVA - Reduced zonular or capsular stability (e.g. Marfan syndrome, previous eye trauma) - Irregular corneal astigmatism on Orbscan topography |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Dr Isaac John | Chertsey | Surrey |
Lead Sponsor | Collaborator |
---|---|
Ashford and St. Peter's Hospitals NHS Trust | Bausch & Lomb Incorporated |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Astigmatism reduction effect of toric intraocular lens (IOL) versus non-toric IOL with limbal relaxing incisions. | Astigmatism reduction will be evaluated with optical biometry, corneal topography | 6 months and 12 months | |
Primary | Astigmatism reduction effect of toric intraocular lens (IOL) versus non-toric IOL | Astigmatism reduction will be evaluated with manifest refraction, autorefraction | 6 months and 12 months | |
Secondary | Unaided visual acuity after toric intraocular lens (IOL) versus non-toric IOL with limbal relaxing incisions. | Measurement of uncorrected visual acuity, monocular and binocular, will be done using a back-lit EDTRS chart placed at 4m. Although these assessments appear to have different units of measurements, but all the measurements will be in the same units of measure. | 6 months and 12 months | |
Secondary | Best-spectacle corrected visual acuity after toric intraocular lens (IOL) versus non-toric IOL with limbal relaxing incisions. | Measurement of best-spectacle corrected visual acuity, monocular and binocular, will be done using a back-lit EDTRS chart placed at 4m. | 6 months and 12 months | |
Secondary | Quality of Vision | Quality of Vision will be evaluated with the QoV (Quality of Vision) questionnaire score. It is a validated, Rasch-adjusted questionnaire in which patients are asked to rate 10 dysphotopsia items illustrated by standard photographs, scoring each item (0, 1, 2, 3) in relation to how frequent, severe, and bothersome their symptoms are (30 items in total). | 6 months and 12 months | |
Secondary | Visual disability | Visual disability will be evaluated with the Catquest 9-SF cataract visual disability questionnaire. It is a Rasch-adjusted cataract visual disability questionnaire that asks patients to rate difficulty with a range of vision-related daily activities. | 6 months and 12 months | |
Secondary | Overall satisfaction | Overall satisfaction will be evaluated with vision rating questionnaire. It will be obtained by asking patients to rate whether they were very satisfied, satisfied, neither satisfied nor unsatisfied, unsatisfied, or very unsatisfied. | 6 months and 12 months | |
Secondary | Dysphotopsia | Dysphotopsia will be evaluated with the Dysphotopsia questionnaire. They are 4 questions regarding dysphotopsia symptoms: "Since your surgery, have you noticed any" halo, glare or dazzle, unwanted images, or shadows? Patients were asked to respond by indicating whether they had not experienced these symptoms at all ("none") or found them "barely noticeable," "annoying," or "debilitating." | 6 months and 12 months |
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