CompletedNot Applicable

Visual Outcomes After Presbyopic Lens Exchange

Germany36 participantsStarted 2019-05-14

Plain-language summary

Evaluation of mean preoperative and postoperative Corrected distance visual acuity (CDVA) after Refractive Lens Exchange in presbyopic patients

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent
✓. Patients of any gender, aged 18 years or older
✓. Assured follow-up examinations
✓. Post-operative astigmatism ≤ 0.75 Diopter
✓. IOL implanted into the capsular bag with trifocal IOL in both eyes
✓. Patients who had bilateral uncomplicated presbyopic lens exchange surgery in both healthy eyes
✓. Preoperative monocular and binocular CDVA equal or better than 0.2 logMAR
✓. Normal findings in the medical history and physical examination

✕. Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial
✕. Patients whose freedom is impaired by administrative or legal order
✕. Concurrent participation in another drug or device investigation that affects patients vision
✕. Signs of early cataract in either eye
✕. Preoperative monocular and binocular CDVA worse than 0.2 logMAR
✕. Clinically significant Posterior capsule opacification (PCO) defined as a CDVA loss of 0.2 logMAR or more in either eye
✕. Cataract of any grade
✕. Ocular disorders, that could potentially cause future acuity loss to a level of 0.20 logMAR (best-corrected) or worse in either eye

Corrected distance visual acuity

Timeframe: 4 to 6 months postop

NCT IDNCT03790592

SponsorCarl Zeiss Meditec AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-12-09

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent
✓. Patients of any gender, aged 18 years or older
✓. Assured follow-up examinations
✓. Post-operative astigmatism ≤ 0.75 Diopter
✓. IOL implanted into the capsular bag with trifocal IOL in both eyes
✓. Patients who had bilateral uncomplicated presbyopic lens exchange surgery in both healthy eyes
✓. Preoperative monocular and binocular CDVA equal or better than 0.2 logMAR
✓. Normal findings in the medical history and physical examination

✕. Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial
✕. Patients whose freedom is impaired by administrative or legal order
✕. Concurrent participation in another drug or device investigation that affects patients vision
✕. Signs of early cataract in either eye
✕. Preoperative monocular and binocular CDVA worse than 0.2 logMAR
✕. Clinically significant Posterior capsule opacification (PCO) defined as a CDVA loss of 0.2 logMAR or more in either eye
✕. Cataract of any grade
✕. Ocular disorders, that could potentially cause future acuity loss to a level of 0.20 logMAR (best-corrected) or worse in either eye