Effect of Ectoine After Photorefractive Keratectomy (PRK). | NCT05313425

Studies
Effect of Ectoine After Photorefractive Keratectomy (PRK).

NCT05313425

Sponsor

Tanta University

Status

Unknown status

Last Update Posted

Apr 6, 2022Actual

Enrollment

15Estimated

Phase

Not provided

Conditions

Photorefractive Keratectomy
Corneal Haze

Interventions

Ectohylo (R) eye drops

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

May 2022Estimated

Completion Date

Oct 2022Estimated

First Submitted Date

Mar 29, 2022

First Submission Date that Met QC Criteria

Mar 29, 2022

First Posted Date

Apr 6, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2022

Last Update Posted Date

Apr 6, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a comparative, open label, parallel group, non interventional study aims to assess the effect of Ectoine containing eye drops on stromal haze, pain and epithelial healing after Photorefractive keratectomy (PRK). The patient apply Ectohylo eye drops (Ectoine +Sodium Hyauronate) in the right eye and Polyfresh Extra eye drops (Carboxymethyl cellulose + Sodium Hyauronate ) in the left eye plus the routine post PRK treatment in both eyes. Post operative pain , epithelial healing and corneal densitometry is observed in both eyes.

Detailed Description

Photorefractive keratectomy (PRK) is a commonly used operation for laser vision correction. The main fears of this type of laser vision correction is corneal haze, delayed epithelial healing and postoperative severe pain. Ectoine is a natural compound that has the ability to protect biological membranes from damage and environmental effects. This study assess the use of Ectoine containing eye drops to protect the bare ocular surface and reduce inflammation after PRK that will inturn is expected to affect the post operative corneal haze, pain, and epithelial healing .

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ectoine Eye		The right eye of the studied group will be given 2% Ectoine containig , 0.2% sodium hyaluronate eye drops(Ectohylo) hourly.	Other: Ectohylo (R) eye drops
Control eye		The left eye of the studied group will be give Carboxymethyl cellulose, 0.2% sodium hyaluronate eye drops(Polyfresh Extra) hourly.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ectohylo (R) eye drops	Other	using Ectohylo eye drops post operative after PRK in the right eyes of the patients	Ectoine Eye

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Corneal Densitometry (assesed by Pentacam).	Post photo refractive keratectomy early haze (3 months after operation) assesed by Pentacam densitometry	3 months post operative

Secondary Outcomes

Measure	Description	Time Frame
Pain score (0 -10)	pain in the first 2 days post operative (graded 0 to 10)	2 days
Time of Epithelial healing (days)	Time required for epithelial healing after PRK in days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient undergoing PRK for myopia and myopic astigmatism when astigmatism is 2.5 diopters or less and myopia with spherical equivalent -4 or less.

Exclusion Criteria:

patient spherical equivalent more myopic than -4 diopters
Patients with astigmatism more than 2.5 diopter
Patients with anisometropia ( difference > 2 diopters)
Patient with previous ocular surgery
Patients with chronic systemic disease that can affect results of laser vision correction (e.g. rheumatoid arthritis)
Pregnant and lactating females

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Patient enrolled for photorefractive keratectomy for correction of myopia and myopic astigmatism.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohamed Elkadim, MD	Contact	01004991183		mzekadem@gmail.com

Overall Officials

Name	Affiliation	Role
Mohamed Elkadim	Tanta University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tanta University	Recruiting	Tanta	El Gharbia	31512	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Data obtained through this study may be provided to qualified researchers with academic interest in Cornea. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

after publication for 5 months

Access Criteria

Authorized Ophthalmologists specialized in cornea and refractive surgery

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003318	Corneal Opacity

Ancestor Terms

ID	Term
D003316	Corneal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009883	Ophthalmic Solutions
C045628	ectoine

Ancestor Terms

ID	Term
D019999	Pharmaceutical Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations
D045506	Therapeutic Uses

Browse Leaves

Not provided

Browse Branches

Not provided