NCT02535819

Brief Summary

Cataract is the clouding of the lens of the eye, which initially prevents clear vision and eventually progresses to blindness if left untreated. Cataract remains the leading cause of blindness and an important cause of visual impairment across the globe. Cataract surgery by ultrasonic phacoemulsification is the most common surgery practiced in France (600 000/year) Two sub-categories of phacoemulsification coexist : Endocapsulars techniques represented by Divide-and-Conquer and Phaco-Chop ; and Supracapsular techniques mainly represented by Subluxation (similar to Tilt-and-Tumble) The corneal endothelium plays an important role in maintaining the dehydrated state and the transparency of the cornea. Some degree of endothelial cell loss invariably occurs in all types of cataract surgery but the amount of endothelial cell loss may varies with the type of surgical technique The aim of the study is to evaluate the density of the central corneal endothelial cells before and after cataract surgery comparing two phacoemulsification techniques (Divide-and-Conquer vs Subluxation)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
294

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 31, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

April 16, 2019

Status Verified

September 1, 2017

Enrollment Period

2.3 years

First QC Date

June 30, 2015

Last Update Submit

April 12, 2019

Conditions

Cataracts

Keywords

Cataract surgery

Outcome Measures

Primary Outcomes (1)

  • Main Outcome Measures: postoperative Endothelial cell loss of the central corneal

    12 month

Study Arms (2)

Subluxation

EXPERIMENTAL

Nucleus is hydrodissected until it lilts above the capsular bag, rotated to face the incision then tumbled and emulsification continues from the opposite equator outside in until complete

Procedure: Subluxation

Divide and Conquer

OTHER

Cataract nucleus is fragmented into 4 pieces then aspirated by ultrasonic vibration

Procedure: Divide and Conquer

Interventions

SubluxationPROCEDURE

One pole of The nucleus is hydrodissected until it lilts above the capsular bag. The tilted nucleus is rotated to face the incision and remaining half nucleus is then tumbled and emulsification continues from the opposite equator outside in until complete

Subluxation
Divide and ConquerPROCEDURE

Cataract nucleus is fragmented into 4 pieces then aspirated by ultrasonic vibration

Divide and Conquer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female aged ≥ 18 years
  • Patients undergoing cataract surgery
  • Visual acuity Monoyer scale \<6/10e (\< +0.2 logMar)
  • Nuclear, cortical and posterior subcapsular cataract with normal density to severe in the LOCSIII classification

You may not qualify if:

  • insulin-dependent diabetes and /or diabetic retinopathy
  • corneal disease: keratitis, dystrophy, corneal degeneration
  • Any disease of intraocular pressure
  • Any disease of the anterior segment
  • Low preoperative endothelial cell density \< 1500 c/mm²
  • Combined surgery (cataract + corneal transplant, cataract + glaucoma surgery, cataract +vitrectomy ...)
  • Risk factors for surgical per-operative complication
  • Pregnancy, lactation
  • Ward of court
  • Patient not covered by the Social Security scheme

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chr Metz Thionville

Metz, 57085, France

Location

Related Publications (2)

  • Leterrier J, Mastrangelo L, Goetz C, Zevering Y, Perone JM. Preoperative and perioperative factors that predict endothelial cell loss 1 year after uncomplicated Descemet membrane endothelial keratoplasty. PLoS One. 2025 Dec 19;20(12):e0339346. doi: 10.1371/journal.pone.0339346. eCollection 2025.

    PMID: 41417772DERIVED

  • Perone JM, Ghetemme C, Zevering Y, Zaidi M, Ouamara N, Goetz C, Lhuillier L. Corneal Endothelial Cell Loss After Endocapsular and Supracapsular Phacoemulsification: The PERCEPOLIS Randomized Clinical Trial. Cornea. 2022 Jun 1;41(6):714-721. doi: 10.1097/ICO.0000000000002822. Epub 2021 Nov 2.

    PMID: 34732666DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Jean-Marc PERONE, MD

    CHR Metz-Thionville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2015

First Posted

August 31, 2015

Study Start

June 1, 2015

Primary Completion

September 1, 2017

Study Completion

May 1, 2018

Last Updated

April 16, 2019

Record last verified: 2017-09

Locations

FR(1)