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OpenTrials
Completed

NCT Number: NCT04783909

Refractive Outcomes After Cataract Surgery in Eyes With Pseudoexfoliation Syndrome

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.

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Key information

Conditions

Refractive Errors Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phacoemulsification Cataract Surgery

Procedure

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.

Primary outcomes

  1. To compare refractive outcomes in PEX and control eyes.

    Time frame: 3 months

    To measure MAE, MedAE, percentage of eyes within certain range of prediction error after cataract surgery

Secondary outcomes

  1. To determine whether any of IOL power prediction formulas is more precise for these challenging eyes.

    Time frame: 3 months

    To measure the effects of IOL power calculation formulas - SRK/T, Barrett Universal II and Hill-RBF - on postoperative refraction

Sponsors and collaborators

Lead sponsor

Medical University of Lublin

Other

Registry information

Official study title

Refractive Outcomes of Phacoemulsification Cataract Surgery in Eyes With Pseudoexfoliation Syndrome

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Mar 5, 2021
Registry last updated
Mar 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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