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NCT04965168

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

NCT ID: NCT04965168

Last Updated: 2021-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2021-10-16

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pseudoexfoliation

Keywords

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DM phacoemulsification endothelial cell density

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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controls

phacoemulsification and IOL implantation

Group Type ACTIVE_COMPARATOR

phacoemulsification of the lens

Intervention Type PROCEDURE

all patients underwent phacoemulsification and IOL implantation for immature cataract extraction

diabetic without pseudoexfoliation

phacoemulsification and IOL implantation

Group Type ACTIVE_COMPARATOR

phacoemulsification of the lens

Intervention Type PROCEDURE

all patients underwent phacoemulsification and IOL implantation for immature cataract extraction

non-diabetic with pseudoexfoliation

phacoemulsification and IOL implantation

Group Type ACTIVE_COMPARATOR

phacoemulsification of the lens

Intervention Type PROCEDURE

all patients underwent phacoemulsification and IOL implantation for immature cataract extraction

diabetic with pseudoexfoliation

phacoemulsification and IOL implantation

Group Type ACTIVE_COMPARATOR

phacoemulsification of the lens

Intervention Type PROCEDURE

all patients underwent phacoemulsification and IOL implantation for immature cataract extraction

Interventions

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phacoemulsification of the lens

all patients underwent phacoemulsification and IOL implantation for immature cataract extraction

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Heba Radi AttaAllah

Associate Professor of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heba R AttaAllah, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Minia University

Locations

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Ophthalmology department/ Minia University Hospital/Minia University

Minya, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND

PMID: 23387877 (View on PubMed)

Fernandez-Munoz 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.

Reference Type BACKGROUND

PMID: 30056522 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 26677035 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 32451432 (View on PubMed)

Quiroga L, Lansingh VC, Samudio M, Pena 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.

Reference Type BACKGROUND

PMID: 20456430 (View on PubMed)

Mahmoud MSE, Omar IAN, AttaAllah HR. Evaluation of the corneal thickness and endothelial changes following uncomplicated phacoemulsification in diabetic and non-diabetic patients with pseudo-exfoliation syndrome by specular microscopy. Int Ophthalmol. 2023 Dec;43(12):4773-4780. doi: 10.1007/s10792-023-02877-x. Epub 2023 Sep 18.

Reference Type DERIVED

PMID: 37721703 (View on PubMed)

Other Identifiers

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691:11/2020

Identifier Type: -

Identifier Source: org_study_id