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Refractive Outcomes After Cataract Surgery in Eyes With Pseudoexfoliation Syndrome

M

Medical University of Lublin

Status

Completed

Conditions

Refractive Errors
Cataract

Treatments

Procedure: Phacoemulsification cataract surgery

Study type

Observational

Funder types

Other

Identifiers

NCT04783909
KE-0254/241/2014

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

PEX
Description:
42 eyes with PEX syndrome and coexisting cataract
Treatment:
Procedure: Phacoemulsification cataract surgery
Control
Description:
38 eyes with cataract only
Treatment:
Procedure: Phacoemulsification cataract surgery

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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