NCT06773273

Brief Summary

Evaluating new technique for treating patients with subluxation using specific laser type and new 6-0 proline fixating novel technique for the capsular bag

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 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

May 28, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 14, 2025

Completed
Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

December 29, 2024

Last Update Submit

January 8, 2025

Conditions

Subluxation

Keywords

Subluxation, CapsuLaser, Prolene, Cionni

Outcome Measures

Primary Outcomes (1)

  • Number of cases with IOL centration inside the capsular bag

    the long term stability of the capsular bag

    6 months

Study Arms (1)

CapsuLaser-Assisted Capsulorhexis and Flanged Prolene Suture

OTHER

CapsuLaser-Assisted Capsulorhexis and Flanged 6-0 Prolene Suture for Cionni Ring Scleral Fixation

Procedure: CapsuLaser-Assisted Capsulorhexis and Flanged Prolene Suture

Interventions

CapsuLaser-Assisted Capsulorhexis and Flanged Prolene SuturePROCEDURE

CapsuLaser-Assisted Capsulorhexis and Flanged 6-0 Prolene Suture for Cionni Ring Scleral Fixation

CapsuLaser-Assisted Capsulorhexis and Flanged Prolene Suture

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Lens subluxation with clear corneal media.

You may not qualify if:

  • Associated macular lesions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maghrabi Eye Hospitals

Jeddah, 22230, Saudi Arabia

Location

MeSH Terms

Conditions

Joint Dislocations

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesWounds and Injuries

Study Officials

  • AHMED SAMIR, MD,PhD

    Zagazig University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This retrospective interventional randomized study included 15 eyes of 15 patients; six of them were due to pseudo exfoliation, five of them were males while the other nine cases were due to hereditary lens subluxation eight of them were females.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2024

First Posted

January 14, 2025

Study Start

May 28, 2024

Primary Completion

October 1, 2024

Study Completion

December 1, 2024

Last Updated

January 14, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)