Condition category
Eye Diseases
Date applied
02/08/2005
Date assigned
21/09/2005
Last edited
19/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.charttrials.abdn.ac.uk/films

Contact information

Type

Scientific

Primary contact

Dr Noemi Lois

ORCID ID

Contact details

Eye Clinic
Foresterhill
Aberdeen
AB25 2ZN
United Kingdom
+44 (0)1224 553217
noemilois@aol.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00286507

Protocol/serial number

HS028 RGC1462

Study information

Scientific title

Acronym

FILMS

Study hypothesis

The principal research question is whether peeling the internal limiting membrane of the retina improves the vision of patients undergoing macular hole surgery. Secondary questions are whether peeling the internal limiting membrane of the retina improves the anatomical outcome of macular hole surgery and, subsequently, the quality of life of patients with macular holes. Whether internal limiting membrane peeling is cost-effective will also be considered.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information can be found at: https://medserv.abdn.ac.uk/films/documents/pdf/patientInformationSmPdf.pdf

Condition

Full-thickness macular holes in the centre of the retina

Intervention

Participants will undergo one of the two possible macular hole surgeries:
1. Surgery without ILM peeling
2. Surgery with ILM peeling

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Distance visual acuity at 6 months post surgery.

Secondary outcome measures

Distance visual acuity at 3 months, near visual acuity at 3 and 6 months, contrast sensitivity at 6 months, reading speed at 6 months, health related quality of life, costs to the health service and the participant, incremental costs per QALY and adverse events.

Overall trial start date

01/06/2005

Overall trial end date

31/05/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with idiopathic full-thickness macular holes (FTMHs) stages 2-3 of equal to or less than 18 months duration and with vision equal to or worse than 20/40 in the study eye.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

Patients with macular holes of stage 1 or 4 or with a hole of greater than 18 months duration will be excluded. If the FTMH is related to high myopia or trauma or there are other causes of decreased vision (e.g. corneal scarring, age-related macular degeneration, diabetic retinopathy, glaucoma if central and/or paracentral absolute visual field defects are present) will also be excluded. Patients who are unable to understand English or give informed consent to be excluded.

Recruitment start date

01/06/2005

Recruitment end date

31/05/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Eye Clinic, Foresterhill
Aberdeen
AB25 2ZN
United Kingdom

Sponsor information

Organisation

University of Aberdeen (UK)

Sponsor details

Kings College
Aberdeen
AB24 3FX
United Kingdom

Sponsor type

University/education

Website

http://www.abdn.ac.uk

Funders

Funder type

Government

Funder name

Chief Scientist Office, Health Department, Scottish Executive (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 protocol in http://www.ncbi.nlm.nih.gov/pubmed/18980675

Publication citations

  1. Protocol

    Lois N, Burr J, Norrie J, Vale L, Cook J, McDonald A, , Clinical and cost-effectiveness of internal limiting membrane peeling for patients with idiopathic full thickness macular hole. Protocol for a randomised controlled trial: FILMS (Full-thickness Macular Hole and Internal Limiting Membrane Peeling Study)., Trials, 2008, 9, 61, doi: 10.1186/1745-6215-9-61.

Additional files

Editorial Notes