Refractive Outcomes After Cataract Surgery in Eyes With Pseudoexfoliation Syndrome

Cataract Clinical Trial

Official title:

Refractive Outcomes of Phacoemulsification Cataract Surgery in Eyes With Pseudoexfoliation Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04783909
• Other study ID #: KE-0254/241/2014
• Status: Completed
• Start date: October 1, 2016
• Est. completion date: May 30, 2018

Study information

• Verified date: March 2021
• Source: Medical University of Lublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 30, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Exfoliation Syndrome
• Refractive Errors

Intervention

Procedure:
• Phacoemulsification cataract surgery
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Lublin

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To determine whether any of IOL power prediction formulas is more precise for these challenging eyes.	To measure the effects of IOL power calculation formulas - SRK/T, Barrett Universal II and Hill-RBF - on postoperative refraction	3 months