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Refractive Outcomes After Cataract Surgery in Eyes With Pseudoexfoliation Syndrome

Refractive Outcomes of Phacoemulsification Cataract Surgery in Eyes With Pseudoexfoliation Syndrome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04783909
Enrollment
80
Registered
2021-03-05
Start date
2016-10-01
Completion date
2018-05-30
Last updated
2021-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractive Errors, Cataract

Keywords

pseudoexfoliation, phacoemulsification cataract surgery, IOL power calculation formulas

Brief summary

To evaluate the refractive outcomes of cataract surgery in PEX syndrome and determine which of the commonly used IOL formulas (SRK/T, Barrett Universal II and Hill-RBF) is the best in predicting postoperative refractive outcomes in PEX.

Detailed description

The primary outcome measure was to compare refractive outcomes (MAE, MedAE, percentage of eyes within certain range of prediction error) in PEX and control eyes. The secondary outcome measure was to determine whether any of IOL power prediction formulas (SRK/T, Barrett Universal II and Hill-RBF) is more precise for these challenging eyes.

Interventions

All surgeries were performed using Infinity (Alcon Laboratories, Inc.) under topical anaesthesia by one surgeon through 2.2 mm incision in the upper corneal limbus. The hydroimplantation of IOL to the capsular bag was performed in all cases.

Sponsors

Medical University of Lublin
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* senile cataract with/without PEX

Exclusion criteria

* corneal pathology * glaucoma, * corneal astigmatism greater than 2.0 diopters (D), * previous eye surgery or subjects with decreased vision due to other reasons than cataract (e.g., exudative age-related macular degeneration (AMD), proliferative diabetic retinopathy, inflammatory eye diseases), * intraoperative complications, * postoperative corrected distance visual acuity (CDVA) worse than 20/40, * axial length below 21 mm and above 25 mm, * dense cataracts or poor fixation requiring ultrasound biometry * eyes with manifest iridophacodonesis and those in which a capsular tension ring was inserted

Design outcomes

Primary

MeasureTime frameDescription
To compare refractive outcomes in PEX and control eyes.3 monthsTo measure MAE, MedAE, percentage of eyes within certain range of prediction error after cataract surgery

Secondary

MeasureTime frameDescription
To determine whether any of IOL power prediction formulas is more precise for these challenging eyes.3 monthsTo measure the effects of IOL power calculation formulas - SRK/T, Barrett Universal II and Hill-RBF - on postoperative refraction

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026