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

• Sponsor: Minia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04965168
• Collaborator: (none)
• Enrollment: 61
• Location: 1
• Arms: 4
• Actual Duration (Months): 10.5
• Patients Per Site Per Month: 5.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pseudoexfoliation	Procedure: phacoemulsification of the lens	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 61 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Evaluation of Corneal Endothelium Following Phacoemulsification in Diabetic and Non-diabetic Patients With Pseudoexfoliation Syndrome by Specular Microscopy
• Actual Study Start Date: Dec 1, 2020
• Actual Primary Completion Date: Oct 12, 2021
• Actual Study Completion Date: Oct 16, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: controls phacoemulsification and IOL implantation	Procedure: phacoemulsification of the lens; all patients underwent phacoemulsification and IOL implantation for immature cataract extraction
Active Comparator: diabetic without pseudoexfoliation phacoemulsification and IOL implantation	Procedure: phacoemulsification of the lens; all patients underwent phacoemulsification and IOL implantation for immature cataract extraction
Active Comparator: non-diabetic with pseudoexfoliation phacoemulsification and IOL implantation	Procedure: phacoemulsification of the lens; all patients underwent phacoemulsification and IOL implantation for immature cataract extraction
Active Comparator: diabetic with pseudoexfoliation phacoemulsification and IOL implantation	Procedure: phacoemulsification of the lens; all patients underwent phacoemulsification and IOL implantation for immature cataract extraction

Outcome Measures

Primary Outcome Measures

1. endothelial cell density [6 months]

   number of endothelial cells

2. Percentage of hexagonal cells [6 months]

   indicator of healthy endothelial cells

3. coefficient of variation (CV) [6 months]

   indicator of the uniformity of the size of endothelial cells

4. Central corneal thickness [6 months]

   measurement of the distance between the epithelium and endothelium at the central cornea

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ophthalmology department/ Minia University Hospital/Minia University	Minya		Egypt	61111

Sponsors and Collaborators

• Minia University

Investigators

• Principal Investigator: Heba R AttaAllah, MD, Faculty of Medicine, Minia University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Aoki T, Kitazawa K, Inatomi T, Kusada N, Horiuchi N, Takeda K, Yokoi N, Kinoshita S, Sotozono C. Publisher Correction: Risk Factors for Corneal Endothelial Cell Loss in Patients with Pseudoexfoliation Syndrome. Sci Rep. 2020 May 26;10(1):8800. doi: 10.1038/s41598-020-66089-4.
• Fernández-Muñoz E, Zamora-Ortiz R, Gonzalez-Salinas R. Endothelial cell density changes in diabetic and nondiabetic eyes undergoing phacoemulsification employing phaco-chop technique. Int Ophthalmol. 2019 Aug;39(8):1735-1741. doi: 10.1007/s10792-018-0995-y. Epub 2018 Jul 28.
• Oltulu R, Satirtav G, Kayitmazbatir ET, Bitirgen G, Ozkagnici A, Karaibrahimoglu A. Characteristics of the cornea in patients with pseudoexfoliation syndrome. Arq Bras Oftalmol. 2015 Nov-Dec;78(6):348-51. doi: 10.5935/0004-2749.20150092.
• Quiroga L, Lansingh VC, Samudio M, Peña FY, Carter MJ. Characteristics of the corneal endothelium and pseudoexfoliation syndrome in patients with senile cataract. Clin Exp Ophthalmol. 2010 Jul;38(5):449-55. doi: 10.1111/j.1442-9071.2010.02313.x. Epub 2010 Apr 28.
• Storr-Paulsen A, Singh A, Jeppesen H, Norregaard JC, Thulesen J. Corneal endothelial morphology and central thickness in patients with type II diabetes mellitus. Acta Ophthalmol. 2014 Mar;92(2):158-60. doi: 10.1111/aos.12064. Epub 2013 Feb 7.

• Responsible Party: Heba Radi AttaAllah, Associate Professor of Ophthalmology, Minia University
• ClinicalTrials.gov Identifier: NCT04965168
• Other Study ID Numbers: 691:11/2020
• First Posted: Jul 16, 2021
• Last Update Posted: Nov 12, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Heba Radi AttaAllah, Associate Professor of Ophthalmology, Minia University: DM; phacoemulsification; endothelial cell density

Study Results

No Results Posted as of Nov 12, 2021