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Stepped Surgery in Uveitic Cataract: A Novel Approach to a Quiet Eye

Primary Purpose

Outcome of Stepped Cataract Surgery in Uveitis

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

cataract surgery

About this trial

This is an interventional treatment trial for Outcome of Stepped Cataract Surgery in Uveitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

the study will include any uveitic patients below 45 years old with complicated cataract and their best corrected visual acuity (BCVA) not better than 6/36 nor worse than hand movement

Exclusion Criteria:

the study will not include those with visual acuity more than 6/36 or patients with active uveitis or with posterior segment pathology discovered by ultrasonography that may affect to a lager extent the visual prognosis

Sites / Locations

Mansoura university

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

stepped cataract surgery

Arm Description

Outcomes

Primary Outcome Measures

Visulal acuity

overall improvement in vision using LogMAR

Secondary Outcome Measures

Intraocular inflammation

flare up of inflammation after surgery USING SUN classification

Full Information

NCT ID

NCT04931277

First Posted

June 12, 2021

Last Updated

June 18, 2021

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT04931277

Brief Title

Stepped Surgery in Uveitic Cataract: A Novel Approach to a Quiet Eye

Official Title

Stepped Surgery in Uveitic Cataract: A Novel Approach to a Quiet Eye

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

February 8, 2021 (Actual)

Primary Completion Date

May 15, 2021 (Actual)

Study Completion Date

May 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This study aims to assess the short-term results of primary phacoemulsification and secondary posterior chamber intraocular lens (PCIOL) implantation in patients with uveitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Outcome of Stepped Cataract Surgery in Uveitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

stepped cataract surgery

Arm Type

Other

Intervention Type

Procedure

Intervention Name(s)

cataract surgery

Intervention Description

stepped surgery in the form of primary phacoemulsification and secondary posterior chamber intraocular lens (PCIOL) implantation in patients with uveitis.

Primary Outcome Measure Information:

Title

Visulal acuity

Description

overall improvement in vision using LogMAR

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Intraocular inflammation

Description

flare up of inflammation after surgery USING SUN classification

Time Frame

6 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: the study will include any uveitic patients below 45 years old with complicated cataract and their best corrected visual acuity (BCVA) not better than 6/36 nor worse than hand movement Exclusion Criteria: the study will not include those with visual acuity more than 6/36 or patients with active uveitis or with posterior segment pathology discovered by ultrasonography that may affect to a lager extent the visual prognosis

Overall Study Officials: