Refractive Outcomes After Cataract Surgery in Eyes With Pseudoexfoliation Syndrome
Refractive Outcomes of Phacoemulsification Cataract Surgery in Eyes With Pseudoexfoliation Syndrome
1 other identifier
observational
80
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2018
CompletedFirst Submitted
Initial submission to the registry
March 3, 2021
CompletedFirst Posted
Study publicly available on registry
March 5, 2021
CompletedMarch 5, 2021
March 1, 2021
1.2 years
March 3, 2021
March 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare refractive outcomes in PEX and control eyes.
To measure MAE, MedAE, percentage of eyes within certain range of prediction error after cataract surgery
3 months
Secondary Outcomes (1)
To determine whether any of IOL power prediction formulas is more precise for these challenging eyes.
3 months
Study Arms (2)
PEX
42 eyes with PEX syndrome and coexisting cataract
Control
38 eyes with cataract only
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.
Eligibility Criteria
Patients above 18 yo with senile cataract with/without PEX without coexisting ocular pathologies
You may qualify if:
- senile cataract with/without PEX
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Wlaz A, Kustra A, Rozegnal-Madej A, Zarnowski T. Intraocular lens power calculations in eyes with pseudoexfoliation syndrome. Sci Rep. 2021 Sep 24;11(1):19071. doi: 10.1038/s41598-021-98675-5.
PMID: 34561548DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Tomasz Żarnowski, MD, PhD, Professor
Medical University in Lublin
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2021
First Posted
March 5, 2021
Study Start
October 1, 2016
Primary Completion
December 31, 2017
Study Completion
May 30, 2018
Last Updated
March 5, 2021
Record last verified: 2021-03