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Corneal Endothelium Evaluation After Phacoemulsification in Diabetec and Non-diabetic Patients With Pseudoexfoliation

M

Minia University

Status

Completed

Conditions

Pseudoexfoliation

Treatments

Procedure: phacoemulsification of the lens

Study type

Interventional

Funder types

Other

Identifiers

NCT04965168
691:11/2020

Details and patient eligibility

About

Our study is a comparative study, that was conducted to evaluate the corneal endothelial cells changes and central corneal thickness after uncomplicated phacoemulsification and intra ocular lens (IOL) implantation in normal controls, in non-diabetic and diabetic patients with PEX, and in patients with PEX only using specular microscopy.

Full description

Our study is a comparative study that included 4 groups (controls, patients with PEX, non-diabetic patients with PEX, diabetic patients with PEX) to evaluate the corneal endothelial cells changes and central corneal thickness after uncomplicated phacoemulsification and intra ocular lens (IOL) implantation using specular microscopy, over a 6 months follow up period.

Enrollment

61 patients

Sex

All

Ages

50 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Senile cataract with age between 50 to 70 years
  • Clear cornea with no zonuler dehiscence
  • Lens opacity classification system III (LOCS III), with grade 2-3 nuclear cataract with any additional cortical (C) and posterior sub capsular (P)

Exclusion criteria

  • Uncontrolled DM in diabetic groups
  • Presence of autoimmune diseases
  • Patients with glaucoma
  • Corneal guttata
  • Zonular dehiscence
  • Rupture posterior capsule during cataract surgery

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

61 participants in 4 patient groups

controls
Active Comparator group
Description:
phacoemulsification and IOL implantation
Treatment:
Procedure: phacoemulsification of the lens
diabetic without pseudoexfoliation
Active Comparator group
Description:
phacoemulsification and IOL implantation
Treatment:
Procedure: phacoemulsification of the lens
non-diabetic with pseudoexfoliation
Active Comparator group
Description:
phacoemulsification and IOL implantation
Treatment:
Procedure: phacoemulsification of the lens
diabetic with pseudoexfoliation
Active Comparator group
Description:
phacoemulsification and IOL implantation
Treatment:
Procedure: phacoemulsification of the lens

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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